[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-lymphocytic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-lymphocytic-leukemia":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,120,0,25,[9,42,73,95,124,147,177,206,242,266,290,312,334,354,376,399,431,510,533,558,593,618,637,665,686],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100609727","phase-4-a-study-of-pirtobrutinib-ly3527727-in-participants-with-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-100609727",false,"NCT07218341","A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\n* Are actively participating in study J2N-MC-JZNN\u002FLOXO-BTK-20020\n\nExclusion Criteria:\n\n* This is not applicable to this study","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN\u002FLOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.",[27,28],"Chronic Lymphocytic Leukemia","Lymphoma, Small Lymphocytic","RECRUITING","2026-08-20",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2026-03-09",{"date":37,"type":21},"2032-12",{"name":39,"class":40},"Eli Lilly and Company","INDUSTRY",50,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100439778","phase-1-a-dose-escalation-and-expansion-study-of-bgb-16673-in-participants-with-b-cell-malignancies-100439778","NCT05006716","A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","CaDAnCe-101","Inclusion Criteria :\n\n1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R\u002FR follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL\u002FSLL), Waldenström macroglobulinemia (WM), R\u002FR diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.\n2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).\n3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.\n4. Phase 2 Cohorts in R\u002FR CLL\u002FSLL, R\u002FR MCL, and R\u002FR WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.\n5. Measurable disease by radiographic assessment or serum IgM level (WM only)\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL\u002FSLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.\n2. Requires ongoing systemic treatment for any other malignancy\n3. Requires ongoing systemic (defined as ≥ 10 mg\u002Fday of prednisone or equivalent) corticosteroid treatment.\n4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease\n5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":51,"type":21},645,[53,54],"PHASE1","PHASE2","Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)",[57,58,59,60,61,27,62,63,64],"B-cell Malignancy","Marginal Zone Lymphoma","Follicular Lymphoma","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Small Lymphocytic Lymphoma","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma",{"date":32,"type":33},{"date":67,"type":33},"2021-09-13",{"date":69,"type":21},"2029-11",{"name":71,"class":40},"BeOne Medicines",115,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100383227","phase-3-testing-early-treatment-for-patients-with-high-risk-chronic-lymphocytic-leukemia-cll-or-small-lymphocytic-leukemia-sll-evolve-cllsll-study-100383227","NCT04269902","Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL\u002FSLL Study","Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL): EVOLVE CLL\u002FSLL Study","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL. Participants must have been diagnosed within 18 months prior to registration\n* Participants must have CLL-International Prognostic Index (CLL-IPI) score \\>= 4 and\u002For complex cytogenetics (defined as 3+ chromosomal abnormalities)\n* Cytogenetic AND\u002FOR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within 18 months prior to registration. At minimum, FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p\n* TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing test is distinct from FISH studies for del(17p)\n\n  * Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk factors that totals a score of 4 on the CLL-IPI score and\u002For has complex cytogenetics completed\n* Immunoglobulin heavy chain locus variable (IgVH) gene mutation analysis performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at any time prior to registration)\n* Serum beta-2 microglobulin level must be obtained within 28 days prior to registration\n* Participants must not meet any of the IWCLL specified criteria for active CLL therapy\n* Treatment with high dose corticosteroids and\u002For intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment\n* Steroids used for treatment of conditions other than CLL\u002FSLL must be at a dose of at most 20 mg\u002Fday of prednisone or equivalent corticosteroid at the time of registration\n* Prior therapy with anti CD20 monoclonal antibodies is not allowed\n* Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved for emergency access use for the prevention or treatment of coronavirus disease 2019 \\[COVID-19\\]), or radiotherapy\n* Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy\n* Participants must be \\>= 18 years of age\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Platelet count \\>= 100,000\u002Fmm\\^3 within 28 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3 within 28 days prior to registration\n* Creatinine clearance \\>= 30mL\u002Fmin (by Cockcroft Gault) within 28 days prior to registration\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3.0 x upper limit of normal (ULN) within 28 days prior to registration\n* Total bilirubin =\\\u003C 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration\n* Participants must be able to take oral medications\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within 6 months, localized prostate cancer treated with surgical resection and\u002For radiation only or requiring no more than chronic hormonal therapy, or prostate cancer with Gleason score ≤ 6, or localized breast cancer treated with surgical resection and\u002For radiation only or requiring no more than chronic hormonal therapy\n* Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor\n* Participants must not have cirrhosis\n* Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocol therapy with V-O.\n\n  * Active infection with hepatitis B or C:\n\n    * Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR).\n  * Latent infection with hepatitis B:\n\n    * Latent infection is defined as meeting all of the following criteria:\n\n      * Hepatitis B surface antigen positive\n      * Anti-hepatitis B total core antibody positive\n      * Anti-hepatitis IgM core antibody undetectable\n      * Hepatitis B PCR undetectable\n    * Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O.\n    * Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis\n* Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and surgeries that occur inside the thoracic or abdomino-pelvic cavities. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. If a participant has had a bone marrow biopsy for diagnosis or evaluation of CLL, this will not exclude the participant from registration to the study. If there is a question about whether a surgery is major or minor, this should be discussed with the Study Chair\n* Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia)\n* Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment\n* Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4\u002F5, as venetoclax is extensively metabolized by CYP3A4\u002F5\n* Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura\n* Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification\n* Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment\n* Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women\u002Fmen of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures\n* Participants must agree to have specimens submitted for translational medicine (MRD) as outlined\n* Participants must be offered the opportunity to participate in specimen banking for future research as outlined.\n\n  * NOTE: With participant's consent, the site must follow through with specimen submission as outlined\n* Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must be offered the opportunity to participate in the quality of life assessments. (Those participants who are unable to read and write in English, Spanish, French, German, Russian or Mandarin may be registered to S1925 without contributing to the quality of life portion of the study.)\n* Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system",{"count":81,"type":21},247,[83],"PHASE3","This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.",[27,62],{"date":32,"type":33},{"date":88,"type":33},"2021-03-02",{"date":90,"type":21},"2028-10-01",{"name":92,"class":93},"National Cancer Institute (NCI)","NIH",631,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":123},"100454411","phase-3-a-phase-3-trial-of-acalabrutinib-obinutuzumab--venetoclax-compared-to-obinutuzumab-and-venetoclax-in-previously-untreated-patients-with-high-risk-cll-100454411","NCT05197192","A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL","A Prospective, Open-label, Multicentre, Randomized, Phase-3-trial of Acalabrutinib, Obinutuzumab and Venetoclax (GAVE) Compared to Obinutuzumab and Venetoclax (GVE) in Previously Untreated Patients With High Risk Chronic Lymphocytic Leukemia (CLL)","Inclusion Criteria:\n\n* Documented CLL\u002FSLL requiring treatment according to iwCLL criteria\n* Age at least 18 years\n* At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases) or an unmutated IGHV gene status.\n* Life expectancy ≥ six months\n* Adequate bone marrow function indicated by a platelet count \\>30 x10\\^9\u002Fl\n* Creatinine clearance ≥ 30ml\u002Fmin\n* Adequate liver function as indicated by a total bilirubin ≤ 2 x, AST\u002F ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient's CLL or to Gilbert's Syndrome\n* Negative testing for hepatitis B (HbsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last treatment cycle),or hepatitis C (negative testing for hepatitis C RNA within 6 wee\n* ks prior to registration for study screening (i.e. PCR only required when serology was positive))\n* ECOG (Eastern Cooperative Oncology Group Performance Status) status 0-2\n\nExclusion Criteria:\n\n* Any prior CLL-specific therapies (except corticosteroid treatment administered due to necessary immediate intervention; within the last 10 days before start of study treatment, only dose equivalents up to 20 mg prednisolone are permitted)\n* Absence of high risk disease (17p-deletion, TP53-mutation complex karyotype\n* An individual organ\u002Fsystem impairment score of 4 as assessed by the CIRS definition (e.g. advanced cardiac disease (NYHA class 3 or 4) limiting the ability to receive the study treatment or any other life-threatening illness, medical condition or organ system dysfunction that, in the investigator´s opinion, could compromise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g. inability to swallow tablets or impaired resorption in the gastrointestinal tract)\n* Transformation of CLL (Richter transformation)\n* Malignancies other than CLL currently requiring systemic therapies\n* Uncontrolled or active infection of HIV\u002FPML or any other active infection\n* Anticoagulant therapy with warfarin or phenoprocoumon\n* Pregnant women and nursing mothers","120 Years",{"count":104,"type":21},202,[83],"This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation, complex karyotype or an unmutated IGHV-gene status).",[27],[109,110,111,112,113],"CLL","high risk","tp53 aberration","complex karyotype","unmutated IGHV gene status","2026-08-19",{"date":30,"type":33},{"date":117,"type":33},"2022-04-19",{"date":119,"type":21},"2028-05",{"name":121,"class":122},"German CLL Study Group","OTHER",30,{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100614256","phase-3-a-study-to-investigate-sonrotoclax-bgb-11417-plus-zanubrutinib-bgb-3111-compared-with-venetoclax-plus-acalabrutinib-in-adults-with-previously-untreated-chronic-lymphocytic-leukemia-100614256","NCT07277231","A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia","A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia","Inclusion Criteria:\n\n* Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment\n* Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2\n* Measurable disease by Computer Tomography\u002FMagnetic Resonance Imaging\n* Adequate bone marrow and organ function\n\nExclusion Criteria:\n\n* Previous systemic treatment for CLL\n* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation\n* Known central nervous system involvement\n* History of confirmed progressive multifocal leukoencephalopathy (PML)\n* Uncontrolled hypertension or clinically significant cardiovascular disease\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":132,"type":21},500,[83],"The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).",[27],[137,138],"B-cell Lymphoma-2 Inhibitor","Bruton Tyrosine Kinase Inhibitor","2026-08-18",{"date":114,"type":33},{"date":142,"type":33},"2026-01-22",{"date":144,"type":21},"2031-11",{"name":71,"class":40},105,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100458832","phase-3-a-study-of-pirtobrutinib-loxo-305-versus-ibrutinib-in-participants-with-chronic-lymphocytic-leukemia-cllsmall-lymphocytic-lymphoma-sll-100458832","NCT05254743","A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL)","A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (BRUIN-CLL-314)","BRUIN-CLL-314","Inclusion Criteria:\n\n* Confirmed diagnosis of CLL\u002FSLL requiring therapy per iwCLL 2018 criteria\n* Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n* Adequate organ function\n\n  * Platelets greater than or equal to ≥ 50 x 10⁹\u002Fliter (L) or ≥30 x 10⁹\u002FL in participants with documented bone marrow involvement considered to impair hematopoiesis,\n  * Hemoglobin ≥8 grams\u002Fdeciliter (g\u002FdL) or ≥6 g\u002FdL in participants with documented bone marrow involvement considered to impair hematopoiesis\n  * Absolute neutrophil count ≥0.75 x 10⁹\u002FL or ≥0.50 × 10⁹\u002FL in participants with documented bone marrow involvement considered to impair hematopoiesis\n  * Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL\u002Fmin)\n\nExclusion Criteria:\n\n* Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment\n* Known or suspected central nervous system (CNS) involvement\n* A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease\n* Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\])\n* Significant cardiovascular disease including ejection fraction \\\u003C 40% and any grade ongoing atrial fibrillation or atrial flutter\n* Hepatitis B or hepatitis C testing indicating active\u002Fongoing infection, based on Screening laboratory tests\n* Active cytomegalovirus (CMV) infection\n* Active uncontrolled systemic bacterial, viral, or fungal infection\n* Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count\n* Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments\n* Ongoing inflammatory bowel disease\n* Previous treatment for CLL\u002FSLL - Part 1: Treatment-naïve and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).\n\nPart 2: participants must be treatment naïve\n\n* Concurrent use of investigational agent or anticancer therapy except hormonal therapy\n* Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist\n* Use of \\> 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug\n* Vaccination with a live vaccine within 28 days prior to randomization\n* Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment\n* Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib",{"count":156,"type":21},737,[83],"The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL\u002FSLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL\u002FSLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.",[27,160,161,62],"Leukemia, Lymphocytic","Leukemia, B-cell",[163,164,165,166],"BTKi","Hematologic Disease","Lymphoma, non-Hodgkin's","Lymphoma, B-cell","2026-08-14",{"date":169,"type":33},"2026-08-17",{"date":171,"type":33},"2022-07-22",{"date":173,"type":21},"2028-01",{"name":175,"class":40},"Loxo Oncology, Inc.",143,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100361429","phase-2-early-clonal-dynamics-during-venetoclax-treatment-for-relapsed-or-refractory-chronic-lymphocytic-leukemia-cll-100361429","NCT03986034","Early Clonal Dynamics During Venetoclax Treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)","Early Clonal Dynamics During Venetoclax Treatment for Chronic Lymphocytic Leukemia (CLL)","-INCLUSION CRITERIA:\n\n1. Diagnosis of CLL\u002FSLL which is made according to the updated criteria of the NCI Working Group.\n2. Active disease as defined by at least one of the following (iwCLL consensus criteria):\n\n   * Weight loss \\>=10% within the previous 6 months\n   * Extreme fatigue\n   * Fevers of greater than 100.5 degrees F for \\>=2 weeks without evidence of infection\n   * Night sweats for more than one month without evidence of infection\n   * Evidence of progressive marrow failure as manifested by the development of, or worsening of\n\n     * Anemia and\u002For thrombocytopenia\n     * Massive or progressive splenomegaly\n     * Massive nodes or clusters or progressive lymphadenopathy\n     * Progressive lymphocytosis with an increase of \\>50% over a 2-month period, or an anticipated doubling time of less than 6 months\n3. Must have designated hematologist\u002Foncologist will assume care and provide venetoclax after the ramp-up phase is complete\n4. Must have G6PD testing performed to determine whether rasburicase can be given\n5. Must have HLA-testing performed to determine whether allopurinol hypersensitivity exists\n6. Age \\>=18 years\n7. ECOG 0-2\n8. Agreement to use acceptable methods of contraception for the duration of venetoclax treatment if sexually active and able to bear or beget children\n9. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty\n10. Able to comprehend the investigational nature of the protocol and provide informed consent\n\nEXCLUSION CRITERIA:\n\n1. Female patients who are currently pregnant or nursing\n2. Any uncontrolled active systemic infection\n3. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator s opinion, could compromise the subject s safety or put the study outcomes at undue risk\n4. Known additional malignancy that is progressing or requires active treatment.\n\n   --Note: Exceptions include basal cell carcinoma of skin, squamous cell carcinoma of skin, and in situ cervical cancer that has undergone potentially curative therapy. Further exceptions include other cancers from which the subject has been diseasefree for \\> 2 years, cancers which will not limit survival to \\\u003C 2 years or cancers in remission receiving endocrine therapy.\n5. Richter s Transformation\n6. Any prior therapy with BCL-2 inhibitors\n7. Concomitant use of strong CYP3A4 inhibitors\n8. Disease significantly affecting gastrointestinal function or absorption\n9. Uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia\n10. Concomitant systemic cancer directed therapy (e.g. immunotherapy, chemotherapy, radiotherapy)\n11. Absolute neutrophil count (ANC) \\\u003C1000\u002FmicroL, platelets (Plt) \\\u003C30,000\u002F microL\n12. Serum bilirubin \\>3 times upper limit of normal (ULN)\n13. Severe psychiatric illness\u002Fsocial situations or cognitive impairment that would limit the patient s ability to tolerate and\u002For comply with study requirements\n\n    * If the PI assesses the decreased ANC and\u002For Plt to be related to CLL involvement, patients may still be enrolled in the study, as cytopenias as expected to improve with treatment of CLL. Patients may receive supportive measures (e.g. transfusions, IVIG, growth factor support, etc.) to avoid severe cytopenias prior to and during therapy with venetoclax.","85 Years",{"count":186,"type":21},75,[54],"Background:\n\nThe drug venetoclax treats chronic lymphocytic leukemia (CLL). Researchers want to find better treatments for CLL. To do that, they need to learn how the drug affects CLL cancer cells and the immune system.\n\nObjective:\n\nTo learn about genetic changes that happen during treatment of CLL with venetoclax.\n\nEligibility:\n\nAdults ages 18 and older with relapsed or refractory CLL after at least 1 prior therapy\n\nDesign:\n\nParticipants will be screened under a separate protocol.\n\nIn Phase 1, participants will get venetoclax free of charge through the NIH. Venetoclax is started at a low dose. The dose will be increased every week until participants reach their maximum tolerable dose. This usually take about 5 weeks. Participants will visit the NIH at least once per week. Visits will be about 4 hours. They may have to stay in the hospital to be observed.\n\nIn Phase 2, participants will continue to get the drug through their local cancer doctor and their health insurance. Patients will also visit the NIH every 6 months, or if their disease progresses.\n\nAt the NIH participants will have regular health assessments. These will include physical exams and a review of the medicines they are taking. They will talk about how they are feeling.\n\nThe study included the following tests:\n\nBlood draws\n\nCT scans: Participants will lie in a machine that takes pictures of the body (maximum 3 per year)\n\nBone marrow biopsies: A small amount of marrow will be taken out of the participant s hip bone with a needle.\n\nOptional lymph node biopsies: A small piece of the participant s tissue will be taken out with a needle.\n\nThe study will last at least 2 years.",[27],[191,192,193,194,195],"ramp-up","Rituximab","Tumor","Treatment","Cancer","2026-08-11",{"date":198,"type":33},"2026-08-12",{"date":200,"type":33},"2019-06-26",{"date":202,"type":21},"2026-11-17",{"name":204,"class":93},"National Heart, Lung, and Blood Institute (NHLBI)",1,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":214,"targetDuration":215,"studyType":216,"phases":4,"briefSummary":217,"conditions":218,"keywords":227,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":205},"100651557","low-dose-liposomal-amphotericin-b-for-antifungal-prophylaxis-in-prolonged-neutropenia-patients-100651557","NCT07763054","Low-dose Liposomal Amphotericin B for Antifungal Prophylaxis in Prolonged Neutropenia Patients","Evaluation of Low-Dose Liposomal Amphotericin B for Prophylaxis of Invasive Fungal Infections in Patients With Prolonged Neutropenia: A Clinical Study","Inclusion Criteria:\n\n* Age 18 to 75 years (inclusive), both sexes.\n* Meets NCCN 2025 V1 guideline criteria for high-risk invasive fungal disease, including allogeneic hematopoietic stem cell transplantation, autologous hematopoietic cell transplantation with mucosal damage, acute leukemia, grade 3\u002F4 graft-versus-host disease, myelodysplastic syndrome, lymphoma, multiple myeloma, chronic lymphocytic leukemia, treatment with purine analogues (fludarabine, clofarabine, nelarabine), chimeric antigen receptor (CAR) T-cell therapy, alemtuzumab therapy, with expected neutropenia \\>7 days and accompanied by agranulocytosis.\n\nNote: Agranulocytosis is defined as absolute neutrophil count ≤0.5×10\\^9\u002FL, or absolute neutrophil count ≤1×10\\^9\u002FL with expected decline to ≤0.5×10\\^9\u002FL within 48 hours.\n\n* Assessed by the study physician as having high-risk for invasive fungal infection, intolerant or unable to use other antifungal agents due to toxicity or other reasons, and the treating physician has independently decided in routine clinical practice to initiate liposomal amphotericin B for antifungal prophylaxis for 3-5 days, with the selected dosage regimen of 50 mg\u002Fday, intravenous, once daily.\n* Patient or legally authorized representative has voluntarily signed the informed consent form.\n\nExclusion Criteria:\n\n* Allergy to any component of liposomal amphotericin B, or development of serious adverse events during the initial 3-5 days of prophylactic use.\n* Prior history of proven or probable invasive fungal disease (IFD).\n* Presence of pneumonia, unexplained fever, or clinical\u002Fimaging evidence suggestive of or diagnosed as fungal infection during screening.\n* Clinically significant hypokalemia (defined as serum potassium \\\u003C3.2 mmol\u002FL, or below the lower limit of normal while receiving digitalis therapy) that cannot be corrected before starting trial treatment.\n* Hepatic dysfunction with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥5× upper limit of normal (ULN), or total bilirubin ≥3× ULN.\n* Renal impairment requiring or currently undergoing hemodialysis or peritoneal dialysis.\n* New York Heart Association (NYHA) Class III\u002FIV heart failure.\n* Positive for human immunodeficiency virus (HIV) antibody or Treponema pallidum hemagglutination assay (TPHA).\n* Expected survival \\\u003C3 months.\n* Pregnant or breastfeeding women, or women of childbearing potential who are not using contraception and planning pregnancy.\n* Any other condition that the investigator considers inappropriate for participation in the clinical trial.","75 Years",{"count":123,"type":21},"7 Days","OBSERVATIONAL","This is a single-center, single-arm, observational clinical study evaluating the efficacy and safety of low-dose liposomal amphotericin B (50 mg\u002Fday, intravenous, once daily) for the prevention of invasive fungal infections in adult patients (aged 18-75 years) with hematological malignancies who develop prolonged neutropenia (absolute neutrophil count ≤0.5×10\\^9\u002FL, expected to last \\>7 days) and are at high risk for invasive fungal disease. Participants are those who, per the treating physician's routine clinical decision, have been initiated on liposomal amphotericin B prophylaxis at 50 mg\u002Fday due to intolerance or toxicity to other antifungal agents. The primary outcome is the incidence of proven or probable invasive fungal disease. Secondary outcomes include incidence of pneumonia, persistent unexplained fever \\>4 days, use of additional systemic antifungal therapy, and adverse events. A total of 30 participants will be enrolled. Data will be collected at baseline, during treatment, and within 7 days after treatment completion.",[219,220,221,222,223,27,224,225,226],"Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Myelodysplastic Syndrome","Lymphoma","Multiple Myeloma","Neutropenia","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Invasive Fungal Infections",[228,229,230,231,232],"Liposomal Amphotericin B","Antifungal Prophylaxis","Invasive Fungal Disease","Prolonged Neutropenia","Hematological Malignancies","2026-08-08",{"date":235,"type":33},"2026-08-13",{"date":237,"type":33},"2025-08-01",{"date":239,"type":21},"2026-11-30",{"name":241,"class":122},"Haikou Affiliated Hospital of Central South University Xiangya School of Medicine",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":251,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100581392","phase-2-zanubrutinib-obinutuzumab-sonrotoclax-boson-or-bgb-16673-obinutuzumab-sonrotoclax-doson-in-tn-cllsll-100581392","NCT06849713","Zanubrutinib, Obinutuzumab, Sonrotoclax (BOSon) or BGB-16673, Obinutuzumab, Sonrotoclax (DOSon) in TN CLL\u002FSLL","A Multicenter Phase 2 Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax (BOSon) or Tacabrutideg (BGB-16673), Obinutuzumab, and Sonrotoclax (DOSon) in Treatment-Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","Inclusion Criteria:\n\n* Participant must have CLL or SLL (WHO criteria).\n* Participant must require treatment according to iwCLL guidelines.\n* Participants must have no prior systemic therapy for CLL or SLL, except:\n\n  * Prior local radiation for symptomatic disease is permitted.\n  * Short course systemic corticosteroids is permissible for disease control, improvement of performance status, or non-cancer indication. However, duration of steroid course must be ≤14 days with maximum daily dose of ≤100 mg prednisone, ≤20 mg dexamethasone, or equivalent, and must be discontinued prior to study treatment (last dose may be administered up until the morning of \u002F prior to study treatment). Inhaled steroids, topical steroids, and replacement \u002F stress corticosteroids are permitted independent of above rules. In cases of autoimmune complications of CLL (e.g., ITP or AIHA), steroid usage is permitted.\n* Age ≥18 years.\n* ECOG performance status of 0, 1 or 2.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥1,000\u002FµL without growth factor support (filgrastim within 5 days or PEGfilgrastim within 10 days of test), unless clearly due to disease under study (per investigator)\n  * platelets ≥75,000\u002FµL, or ≥20,000\u002FµL if clearly due to disease under study (per investigator)\n  * total bilirubin ≤2 x institutional upper limit of normal (ULN), or ≤3 x institutional ULN if due to Gilbert's syndrome, or with PI approval if clearly due to disease under study\n  * AST(SGOT)\u002FALT(SGPT) ≤2.5 x × institutional ULN\n  * CrCl or GFR ≥30 mL\u002Fmin as estimated by the Cockcroft-Gault equation, the CKD-EPI equation, or as measured by 24-hour urine collection\n* For females of childbearing potential, a serum pregnancy test must be negative within screening period.\n* For female patients of childbearing potential: agreement to use highly effective form(s) of contraception (i.e., one that results in a low failure rate \\[\\\u003C1% per year\\] when used consistently and correctly) or remain abstinent (refrain from heterosexual intercourse) during the treatment period and to continue its use for ≥ 30 days after the last dose of zanubrutinib or BGB-16673 or ≥ 7 days after the last dose of sonrotoclax, and for ≥18 months fter the last dose of obinutuzumab (whicher is later).\n\n  * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\>12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.\n  * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* For men with a female partner of childbearing potential or a pregnant female partner: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom in addition to 1 of the highly effective methods of contraception listed below, from the time of taking the first dose of study drug , during the treatment period and to continue its use for ≥ 30 days after the last dose of zanubrutinib or BGB-16673 or ≥ 7 days after the last dose of sonrotoclax, and for ≥18 months fter the last dose of obinutuzumab (whicher is later).\n\n  --The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* Willingness to not donate or bank sperm or oocytes during the entire study treatment period and after treatment discontinuation for for ≥ 30 days after the last dose of zanubrutinib or BGB-16673 or ≥ 7 days after the last dose of sonrotoclax, and for ≥18 months fter the last dose of obinutuzumab (whicher is later).\n* Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)\n\nExclusion Criteria:\n\n* Known histologic transformation from CLL or SLL to an aggressive lymphoma (i.e., Richter's transformation).\n* Known central nervous system involvement with CLL or SLL.\n* Other diagnosis of active malignancy or systemic therapy within 2 years of study treatment. Note: An active malignancy or systemic therapy within 2 years for another malignancy, whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Also, local\u002Fregional therapy with curative intent such as surgical resection or localized radiation at any timepoint is permitted.\n* Any uncontrolled illness that in the opinion of the investigator would preclude administration of study therapy (e.g., significant active infections, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction).\n* Congestive heart failure, New York Heart Association III\u002FIV. Unstable angina within 3 months before screening, myocardial infarction within 6 months before screening. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes). Heart rate-corrected QT interval \\> 480 milliseconds based on Fridericia's formula corrected for bundle branch block as appropriate. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place.\n* Receipt of a live-virus vaccine within 28 days prior to initiation of study treatment or need for live-virus vaccine at any time during study treatment.\n* Active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds).\n* Known bleeding diathesis. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.\n* Prior major surgical procedure within 4 weeks of study, or anticipation of need for a major surgical procedure during the course of the study.\n* Known CNS hemorrhage or stroke within 6 months of the study.\n* History of progressive multifocal leukoencephalopathy.\n* History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection.\n\n  * Patients with a history of HIV infection that is well controlled on antiretroviral therapy are eligible if all of the following criteria are met: (1) undetectable HIV viral load by standard clinical assay AND (2) CD4+ T cell count of \\>\u002F=200 cells\u002Fmicroliter). NOTE: Many HIV regimens are excluded based on drug interactions, and concomitant antiretroviral therapy must be acceptable per protocol.\n  * Participants with occult or prior HBV infection (defined as positive total hepatitis B core antibody \\[HBcAb\\] and negative HBsAg) may be included if HBV DNA is undetectable, and if the participant is willing to take appropriate anti-viral prophylaxis as indicated and HBV DNA monitoring on study.\n  * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n\nKnown condition or other clinical situation resulting in inability to swallow oral medications, or that would impair absorption of oral medications.\n\n* Participant in a separate investigational therapeutic trial unless authorized by the PI.\n* Concurrent therapy with, or administration within 5 half-lives 14 days prior to the first dose of study drug (whichever is shorter), with moderate or strong inhibitors or inducers of CYP3A.\n* Concomitant use of warfarin or warfarin derivatives.\n* Concomitant use of dual antiplatelet therapy.\n* Prior systemic therapy for CLL or SLL, except for localized radiation or corticosteroids as per 3.1.3.\n* Prior anti-CD20 monoclonal antibody therapy for any indication (malignant or non-malignant).\n* Participants with a contraindication to obinutuzumab based on known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients. Hypersensitivity to zanubrutinib or sonrotoclax.\n* Consumption of one or more of the following within 3 days prior to the first dose of study drug: grapefruit or grapefruit products, Seville oranges including marmalade containing Seville oranges, or Star fruit (carambola).\n* Known psychiatric illness or social situation that would interfere with study adherence.\n* Pregnant women are excluded from this study given potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued prior to the first dose of study drug if the mother is treated.\n* Uncontrolled autoimmune anemia and\u002For autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura), e.g., with need for ongoing corticosteroid treatment (see 3.2.24).\n* Requires ongoing need for corticosteroid treatment. NOTE: Systemic corticosteroids must be fully tapered off\u002Fstopped before first study drug.\n* Uncontrolled hypertension at Screening, defined as systolic blood pressure \\> 170 mmHg and diastolic blood pressure \\> 105 mmHg by ≥ 2 consecutive measurements. In patients NOT meeting these parameters for uncontrolled hypertension, repeat blood pressure measurement is NOT required for eligibility.\n* Prior invasive fungal infections, except if patient agrees to receive secondary antifungal prophylaxis during the entire treatment period (Cohort 2 Only).\n* Patients with known contraindication to azole antifungal agents, including hypersensitivity reactions (Cohort 2 Only).",{"count":250,"type":21},80,[54],"The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).",[27,254],"Small Lymphocytic Lymphoma (SLL)",[109,256,257],"SLL","untreated",{"date":196,"type":33},{"date":260,"type":33},"2025-05-16",{"date":262,"type":21},"2030-03-01",{"name":264,"class":122},"Massachusetts General Hospital",2,{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},"100588628","a-study-to-investigate-progression-free-survival-with-sonrotoclax-plus-obinutuzumab-or-sonrotoclax-plus-rituximab-compared-with-venetoclax-plus-rituximab-treatment-in-patients-with-relapsed-andor-refractory-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-celestial-rrcll-100588628","NCT06943872","A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and\u002For Refractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CELESTIAL-RRCLL)","A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Inclusion Criteria:\n\n* Confirmed diagnosis of CLL\u002FSLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria\n* Received one or more prior therapies for CLL\u002FSLL. For each line of therapy, participants must have received at least 2 cycles of the therapy\n* Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known active prolymphocytic leukemia or currently suspected Richter's transformation\n* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug\n* Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent\n* Known central nervous system involvement by CLL\u002FSLL\n* Severe or debilitating pulmonary disease\n* Clinically significant cardiovascular disease\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":274,"type":21},630,[83],"The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and\u002For refractory (R\u002FR) chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R\u002FR CLL\u002FSLL. The safety of these treatments will also be assessed.",[27,62],[279,280,121],"B-cell lymphoma 2 inhibitor (BCL-2i)","CLL-RR1","2026-08-06",{"date":283,"type":33},"2026-08-10",{"date":285,"type":33},"2025-06-11",{"date":287,"type":21},"2031-12",{"name":71,"class":40},195,{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":311},"100581158","phase-3-a-study-of-bgb-16673-compared-to-investigators-choice-in-participants-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-previously-exposed-to-both-bruton-tyrosine-kinase-btk-and-b-cell-leukemialymphoma-2-protein-bcl2-inhibitors-100581158","NCT06846671","A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia\u002FLymphoma 2 Protein (BCL2) Inhibitors","A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors","CaDAnCe-302","Inclusion Criteria:\n\n1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.\n2. Previously received treatment for CLL\u002FSLL with both a BTKi and a BCL2i.\n3. Participants with SLL must have measurable disease by computer tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2\n5. Adequate liver function\n6. Adequate blood clotting function\n\nExclusion Criteria:\n\n1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation\n2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months\n3. Known central nervous system involvement\n4. Prior exposure to any BTK protein degraders\n5. Active fungal, bacterial and\u002For viral infection requiring parenteral systemic therapy\n6. Clinically significant cardiovascular disease\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":299,"type":21},250,[83],"The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab \\[for CLL only\\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).",[109,27],[109],{"date":305,"type":33},"2026-08-07",{"date":307,"type":33},"2025-04-10",{"date":309,"type":21},"2030-02-14",{"name":71,"class":40},127,{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":333},"100569664","a-study-to-investigate-the-safety-of-novel-dose-ramp-up-schedules-when-initiating-sonrotoclax-in-participants-treated-for-blood-cancers-100569664","NCT06697184","A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.","A Phase 1\u002F2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.","Inclusion Criteria:\n\n1. Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.\n2. Adequate organ function and no very recent transfusion or blood growth factor\n3. Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later.\n\n   Only for participants with Chronic Lymphocytic Leukemia (CLL):\n4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease\n5. At least 1 measurable lesion based on computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.\n\n   Only for participants with Mantle cell lymphoma (MCL):\n6. Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).\n7. Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.\n8. Measurable disease defined as ≥ 1 nodal lesion that is \\> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \\> 1 cm in longest diameter.\n\nExclusion Criteria:\n\n1. Participants unable to comply with the requirements of the protocol\n2. Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n3. Positive HIV serology (HIVAb) status unless certain conditions are met.\n4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment\n5. Prior systemic treatment for the CLL\n6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment\n7. Prior exposure to a BCL-2 inhibitor\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":320,"type":21},258,[53,54],"The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.",[27,109,63,324],"MCL",[326,232],"CLL previously untreated",{"date":283,"type":33},{"date":329,"type":33},"2025-01-23",{"date":331,"type":21},"2032-11-30",{"name":71,"class":40},17,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":353},"100526578","phase-3-a-study-of-nemtabrutinib-mk-1026-versus-comparator-investigators-choice-of-ibrutinib-or-acalabrutinib-in-first-line-1l-chronic-lymphocytic-leukemia-cll-small-lymphocytic-lymphoma-sll-mk-1026-011bellwave-011-100526578","NCT06136559","A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)\u002F Small Lymphocytic Lymphoma (SLL) (MK-1026-011\u002FBELLWAVE-011)","A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (BELLWAVE-011)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Confirmed diagnosis of CLL\u002FSLL and active disease clearly documented to have a need to initiate therapy.\n* Has at least 1 marker of disease burden.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.\n* Has the ability to swallow and retain oral medication.\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.\n* Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has an active hepatitis B virus\u002F hepatitis C virus (HBV\u002FHCV) infection.\n* Has gastrointestinal (GI) dysfunction that may affect drug absorption.\n* Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL\u002FSLL.\n* Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.\n* Has clinically significant cardiovascular disease.\n* Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.\n* Has history of severe bleeding disorder.\n* Has known additional malignancy that is progressing or has required active treatment within the past 2 years.\n* Has received any systemic anticancer therapy for CLL\u002FSLL.\n* Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.\n* Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.",{"count":342,"type":21},1200,[83],"The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.",[27,62],{"date":305,"type":33},{"date":348,"type":33},"2023-12-13",{"date":350,"type":21},"2032-09-07",{"name":352,"class":40},"Merck Sharp & Dohme LLC",201,{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":365,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":375},"100590881","phase-3-a-study-to-evaluate-the-safety-and-efficacy-of-bgb-16673-compared-to-pirtobrutinib-in-adults-with-relapsedrefractory-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-100590881","NCT06973187","A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed\u002FRefractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","Inclusion Criteria:\n\n* Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria\n* Previously received treatment for CLL\u002FSLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.\n* Participants with SLL must have measurable disease by computed tomography\u002Fmagnetic resonance imaging, defined as ≥ 1 lymph node \\> 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.\n\nExclusion Criteria:\n\n* Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.\n* History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug\n* Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).\n* Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL\u002FSLL\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":132,"type":21},[83],"The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R\u002FR) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).",[27,62],[366,367],"Noncovalent Bruton tyrosine kinase inhibitor","Bruton tyrosine kinase-targeted protein degrader","2026-08-05",{"date":281,"type":33},{"date":371,"type":33},"2025-09-04",{"date":373,"type":21},"2028-04-17",{"name":71,"class":40},204,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":383,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":398},"100617671","phase-3-testing-the-addition-of-anti-cancer-drug-sonrotoclax-to-the-standard-treatment-zanubrutinib-for-previously-untreated-cllsll-100617671","NCT07321652","Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL\u002FSLL","Phase III Evaluation of Fixed Duration Zanubrutinib Plus Sonrotoclax-Based Therapy Compared to Continuous Zanubrutinib in Previously Untreated Older Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL)","Inclusion Criteria:\n\n* STEP 0: This bone marrow or peripheral blood submission to Adaptive is mandatory prior to registration\u002Frandomization for real-time identification of the clone needed for MRD testing. The bone marrow sample should be from the first aspiration (i.e., first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be obtained as soon after pre-registration as possible to confirm registration eligibility\n* STEP 0: Patients must be diagnosed with CLL\u002FSLL according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria that includes all of the following:\n\n  * ≥ 5 x10\\^9 \u002FL B lymphocytes (5000\u002FμL) in the peripheral blood (CLL) or a lymph node biopsy demonstrating SLL with the below immunophenotype (SLL)\n  * On morphologic review, the leukemic cells must be small mature lymphocytes\n  * Immunophenotype of CLL cells (performed locally) must reveal a clonal B-cell population, which coexpress the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in \\> 10% of cells must lack t(11;14) translocation by interphase cytogenetics\n* STEP 0: Patients must meet criteria for treatment as defined by IWCLL 2018 guidelines which includes at least one of the following criteria:\n\n  * Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia), typically hemoglobin (Hb) \\\u003C 10 g\u002FdL, platelet count \\\u003C 100,000\u002Fmm\\^3\n  * Massive (\\> 6 cm below the costal margin), progressive or symptomatic splenomegaly\n  * Massive nodes (ie, \\> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy\n  * Autoimmune anemia and\u002For thrombocytopenia that is poorly responsive to standard therapy\n  * Constitutional symptoms, which include any of the following:\n\n    * Unintentional weight loss of ≥ 10% within the previous 6 months\n    * Significant fatigue (ie. Eastern Cooperative Oncology Group \\[ECOG\\] performance status \\[PS\\] ≥ 2)\n    * Fevers \\>100.5 °F or 38.0°C for 2 weeks or more without evidence of infection\n    * Night sweats \\> 1 month without evidence of infection\n* STEP 0: Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids)\n* STEP 0: Treatment with rituximab and\u002For high-dose corticosteroids for autoimmune complications of CLL must be completed prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg\u002Fday of prednisone or equivalent corticosteroid at the time of registration\n* STEP 0: Age ≥ 65 years\n* STEP 0: ECOG performance status ≤ 2\n* STEP 0: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n* STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* STEP 0: Patients with a history of hepatitis C virus (HCV), infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* STEP 0: Patients must not be receiving active systemic anticoagulation with warfarin. Patients must be off warfarin therapy for at least 5 half-lives washout and with normal INR prior to enrollment\n* STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be class 2B or better.\n\nPatients with acute cardiac events within 6 months prior to registration should be carefully evaluated for their suitability for enrollment\n\n* STEP 0: No patients with a history of a severe bleeding disorder or a history of hemorrhagic stroke or intracranial hemorrhage\n* STEP 0: No patients with known active progressive central nervous system (CNS) disease\n* STEP 0: No known medical condition causing an inability to swallow oral formulations of agents\n* STEP 1: The adaptive report confirming a measurable and trackable B cell clone\n* STEP 1: Patients may not have had major surgery within 7 days of enrollment, or minor surgery within 5 days of enrollment. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician\n* STEP 1: No patients with ongoing active fungal, bacterial or viral infection requiring systemic therapy except those described in the protocol document\n* STEP 1: Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily\n* STEP 1: Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics\n* STEP 1: Patients must not have continued requirement for therapy with a strong CYP3A4\u002F5 inhibitor or inducer. Any such inhibitor or inducer must have been discontinued at least 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug\n* STEP 1: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3 unless due to marrow involvement\n* STEP 1: Platelet count ≥ 30,000\u002Fmm3\n* STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless due to liver involvement, hemolysis or Gilbert's disease)\n* STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x upper limit of normal (ULN) unless due to disease infiltration of the liver\n* STEP 1: Calculated (calc.) creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) ≥ 30 mL\u002Fmin\n* STEP 1: Urine protein to creatinine ratio \\\u003C 1 or urine protein ≤ 1+\n* STEP 2: Detectable MRD ≥ 10 residual clonal cells per million nucleated cells in peripheral blood at the C15 restaging evaluation from ClonoSEQ\n* STEP 2: Response of PR, PR-L, CR, CCR or CRi to zanubrutinib sonrotoclax therapy","65 Years",{"count":385,"type":21},466,[83],"This phase III trial compares the effect of adding sonrotoclax to zanubrutinib versus zanubrutinib alone for the treatment of patients with untreated chronic lymphoblastic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL). Sonrotoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Giving sonrotoclax and zanubrutinib may be more effective than zanubrutinib alone for the treatment of untreated CLL\u002FSLL.",[27,389],"Small Lymphocytic Leukemia","2026-08-04",{"date":368,"type":33},{"date":393,"type":33},"2026-04-30",{"date":395,"type":21},"2038-09-30",{"name":397,"class":122},"Alliance for Clinical Trials in Oncology",182,{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":406,"maxAge":407,"enrollmentInfo":408,"targetDuration":4,"studyType":22,"phases":410,"briefSummary":411,"conditions":412,"keywords":420,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":430},"100557089","phase-1-gene-therapy-for-cd19-positive-hematologic-malignancies-sentry-cd19-100557089","NCT06533579","Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)","A Phase 1\u002F2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)","Inclusion Criteria:\n\n* Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age\n* Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol\n* CD19-positive expression\n* AAV specified capsid total antibody \\\u003C1:400\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity\n* Chemotherapy given within the protocol-specified discontinuation timelines\n\nOther Inclusion\u002FExclusion criteria to be applied per protocol.","13 Years","90 Years",{"count":409,"type":21},32,[53,54],"This is a Phase 1\u002F2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.",[413,414,27,62,58,59,63,64,415,416,417,418,419],"B-cell Acute Lymphoblastic Leukemia","Large B-cell Lymphoma","High-grade B-cell Lymphoma","Burkitt Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Non Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia",[421,422,222],"CD19-positive","Leukemia",{"date":281,"type":33},{"date":425,"type":33},"2025-05-30",{"date":427,"type":21},"2031-09",{"name":429,"class":40},"Vironexis Biotherapeutics Inc.",11,{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":438,"sex":17,"minAge":439,"maxAge":213,"enrollmentInfo":440,"targetDuration":4,"studyType":216,"phases":4,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":509},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928","NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages",true,"40 Years",{"count":441,"type":21},2000,"This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[220,219,444,445,446,447,27,448,449,450,451,452,453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502],"Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Myeloid Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Sarcoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma",{"date":368,"type":33},{"date":505,"type":33},"2022-08-18",{"date":507,"type":21},"2027-02-28",{"name":397,"class":122},744,{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":22,"phases":519,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":524,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":205},"100633431","phase-2-study-on-treatment-outcome-patterns-for-patients-with-cll-after-discontinuation-of-btk-inhibitors-100633431","NCT07526597","Study on Treatment Outcome Patterns for Patients With CLL After Discontinuation of BTK Inhibitors","STOP-CLL-DCT","Inclusion Criteria:\n\nIn order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subjects is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Eastern Cooperative Oncology Group Performance Status of 0-3 or Karnofsky Performance Status of ≥40\n* Confirmed of a diagnosis of CLL (Chronic Lymphocytic Leukemia) or SLL (Small Lymphocytic Lymphoma) according to International Workshop on Chronic Lymphocytic Leukemia 2018 Guidelines at any point prior to study enrollment.\n* At the time of enrollment, patients must be receiving treatment with a covalent Bruton tyrosine kinase inhibitor in the first or second line setting and have been receiving this treatment for at a minimum 2 years. Patients may have previously received anti-CD20 monoclonal antibodies (such as rituximab or obinutuzumab) in combination with the cBTKi.\n\nExclusion Criteria:\n\n* Patients must not have evidence of progressive CLL as defined by IWCLL 2018 criteria.\n* Participants with history of malignancy other than CLL\u002FSLL are allowed",{"count":518,"type":21},45,[54],"This Phase II hybrid decentralized multicenter study examines the outcomes of stopping Bruton tyrosine kinase inhibitor (BTKi) therapy in patients with chronic lymphocytic leukemia (CLL) who have remained in remission for at least two years. The primary objective is to determine how long patients remain free from disease progression or death after discontinuing treatment, measured as event free survival.\n\nThe study also evaluates whether stopping BTKi therapy leads to improvements in quality of life and reductions in treatment related side effects. Researchers will follow patients over time to assess if the cancer returns, whether resistance to therapy develops, and how patients feel during the treatment free period.\n\nIn addition, the trial will investigate how discontinuing BTKi therapy affects immune function, including whether immune recovery occurs and infection risk decreases.\n\nPreliminary data indicate that patients may experience a treatment free interval exceeding two years after stopping therapy, with associated improvements in quality of life. By prospectively evaluating a time limited treatment strategy, this trial aims to determine whether durable disease control can be maintained off therapy while also assessing the resolution of BTKi related adverse events and changes in patient reported outcomes.\n\nOverall, the study seeks to determine whether patients can safely discontinue BTKi therapy and potentially restart treatment later if needed, thereby maintaining disease control while reducing the burden of continuous therapy.",[27,62],[523],"Bruton's tyrosine kinase inhibitors (BTKi)","NOT_YET_RECRUITING","2026-08-03",{"date":368,"type":33},{"date":528,"type":21},"2026-09",{"date":530,"type":21},"2032-06",{"name":532,"class":122},"UNC Lineberger Comprehensive Cancer Center",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":540,"enrollmentInfo":541,"targetDuration":4,"studyType":22,"phases":543,"briefSummary":544,"conditions":545,"keywords":546,"overallStatus":524,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":557},"100649759","phase-2-epcoritamab-plus-venetoclax-plus-ibrutinib-in-patients-with-chronic-lymphocytic-leukemia-with-tp53-alterations-100649759","NCT07738887","Epcoritamab Plus Venetoclax Plus Ibrutinib in Patients With Chronic Lymphocytic Leukemia With TP53 Alterations","EVITA","Inclusion Criteria:\n\n1. Participant who understood and voluntarily signed and dated an informed consent form prior to any trial-specific assessments\u002Fprocedures being conducted\n2. Must be able to adhere to the trial visit schedule and other protocol requirements\n3. Age between ≥ 18 years and \\\u003C 80 years at the time of signing the informed consent form (ICF)\n4. Cumulative Illness Rating Score (CIRS) ≤ 6\n5. CD20+, untreated and documented CLL or SLL, with a Royal Marsden Hospital (RMH) or Matutes Score \\> 3. For SLL a detectable clone with a CLL phenotype in the peripheral blood is a prerequisite for trial participation.\n6. Presence of TP53 abnormalities (either 17p deletion by FISH and\u002For TP53 mutations) according to ERIC recommandations.17\n7. Participant requiring treatment according to 2018 iwCLL guidelines 18\n8. Presence of measurable disease (absolute lymphocyte count \\> 5,000\u002FμL, palpable or measurable lymph node ≥1.5cm on imaging, or bone marrow involvement\n9. ECOG performance status 0 to 2\n10. Adequate hematopoietic function within 7 days before the participant's enrollment\n\n    * ANC ≥ 1 G\u002FL\n    * And Platelets ≥ 50 G\u002FL\n    * And Hemoglobin ≥ 8 g\u002FdL\n\n    Note: Platelets and\u002For red blood cells transfusions may be administered during screening to meet this requirement\n11. Adequate renal function defined by a Creatinine Clearance ≥ 50 ml\u002Fmin calculated according to MDRD or CKD-EPI or Cockcroft-Gault (using actual body weight).\n12. Adequate liver function, as indicated by a total bilirubin \\\u003C1.5 x ULN, AST and ALT \\\u003C3 x ULN value, unless directly attributed to the participant's CLL\u002FSLL or to Gilbert's Syndrome (the ULN is based on institutional values)\n13. The participant must have been vaccinated against pneumococcal (\\\u003C 5 years) and SARS-CoV-2 (\\\u003C 1 year) with at least 21 days between the last vaccination and the participant's enrollment\n14. Woman of childbearing potential (WOCBP):\n\n    * should have a negative result for pregnancy test (minimum sensitivity of 25 mIU\u002FmL, urine or serum), within 28 days prior the participant's enrollment\n    * should agree to use 1 form of highly effective method of contraception from the time of screening until at least 12 months after the final dose of epcoritamab, or at least 3 months after the final dose of ibrutinib or at least 30 days after the final dose of venetoclax, whichever is the longest\n15. Woman should agree to abstain from breastfeeding during trial participation and at least 4 months after the last study treatment administration\n16. Woman should agree to perform further pregnancy testing monthly\n17. Woman should agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial, until 12 months after the last administration of study treatment.\n18. Man of reproductive potential should agree to use an acceptable method of birth control during treatment and until at least 12 months after the final dose of epcoritamab, 3 months after the final dose of ibrutinib and 30 days after the final dose of venetoclax (see section 15.7.3 Acceptable birth control methods). Men should agree not to donate sperm during the entire trial and until 12 months after the last administration of study treatment.\n19. Participant covered by any social security system (France)\n20. Participant who understands and speaks one of the country official languages unless local regulation authorizes independent translators\n21. Life expectancy \\> 6 months\n\nExclusion Criteria:\n\n1. Any prior CLL or SLL-specific therapies, even including rituximab used for autoimmune cytopenias.\n2. Clinically significant cardiovascular disease including the following:\n\n   1. Myocardial infarction within 6 months prior to ICF signature\n   2. Unstable angina within 3 months prior to ICF signature\n   3. NYHA class III or IV heart failure\n   4. Uncontrolled hypertension\n   5. History of clinically significant arrhythmias (including sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes).\n   6. QTcF \\> 480 msec using the Fridericia formula\n   7. History of Mobitz II second- or third-degree heart block without permanent pacemaker\n   8. LVEF \\\u003C50% as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan\n3. Child-Pugh liver cirrhosis.\n4. Clinical evidence for Central Nervous System involvement by CLL\n5. History of ongoing or confirmed Progressive Multifocal Leukoencephalopathy (PML).\n6. Active autoimmune disease or other disease requiring permanent immunosuppressive treatment including steroids therapy \\> 20mg daily of prednisone dose or equivalent within 15 days prior participant's enrollment\n7. Active, uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura, requiring steroid therapy with \\> 20 mg daily of prednisone dose or equivalent within 15 days prior participant's enrollment\n8. Any prior history of Richter transformation or DLBCL\n9. Active malignancy other than the one treated in this trial. Prior history of malignancies unless the participant has been free of the disease for ≥ 2 years.\n\n   However, participants with the following history \u002Fconditions that have been treated with a curative intent are allowed:\n   1. Non-invasive basal cell or epidermoid carcinoma (non melanoma)\n   2. In situ carcinoma of the cervix\n   3. In situ carcinoma of the breast\n   4. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis \\[TNM\\] clinical staging system Woman with adjuvant endocrine therapy (I.e., hormonotherapy) after breast cancer treatment can be enrolled if hormonotherapy was started for ≥ 2 years\n10. History of stroke or intracranial hemorrhage within 6 months prior to ICF signature.\n11. Major surgery anticipated before the ICF signature\n12. Known bleeding disorders\n13. Active Hepatitis C Virus (HCV) infection (RNA PCR-positive). Participants who received treatment for HCV infection that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable\n14. Active Hepatitis B Virus (HBV) infection (DNA PCR-positive). Participants with evidence of prior HBV infection but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy during the entire treatment with active monitoring of viral load in the blood\n15. Known history of seropositivity for HIV infection\n16. Known or suspected hypersensitivity or anaphylaxis to trial intervention(s) including active substance or to any of the excipients.\n17. Requires treatment with warfarin, other vitamin K antagonists, or dual antiplatelet therapy\n18. Requires treatment with a strong cytochrome CYP3A4 inhibitor\u002Finducer\n19. Vaccinated with live, attenuated vaccines within 6 months of enrollment\n20. Participation in another clinical study who would compromise the participation to the current study.\n21. Use of any standard or experimental anti-cancer drug therapy within 28 days or 5 half-lives (whichever is shorter) before the participant's enrollment\n22. Any prior therapy with a bispecific antibody targeting CD3 and CD20\n23. Prior allogeneic stem cells or autologous transplant.\n24. Pregnant, planning to become pregnant or lactating woman\n25. Any significant medical conditions, or laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical trial (according to the investigator's decision)\n26. Ongoing active bacterial, viral, fungal, mycobacterial, parasitic or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrollment or within the previous 2 weeks prior to the first dose of trial drug, including COVID-19 infection and participants with positive cytomegalovirus PCR.\n27. Participant deprived of their liberty by a judicial or administrative decision\n28. Participant hospitalized without consent\n29. Adult participant under legal protection","79 Years",{"count":542,"type":21},44,[54],"This is a phase 2, open-label, multicenter study evaluating the efficacy and safety of a fixed-duration combination of epcoritamab, venetoclax, and ibrutinib (EVI) in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have TP53 alterations.\n\nPatients with TP53 abnormalities, including TP53 mutation and\u002For 17p deletion, have a poorer prognosis and are less likely to benefit from conventional chemoimmunotherapy. Targeted therapies such as ibrutinib and venetoclax have improved outcomes in this population, but many patients eventually experience disease progression. This study investigates whether adding epcoritamab, a CD3×CD20 bispecific antibody, to the combination of ibrutinib and venetoclax can improve the depth and durability of treatment responses while using a fixed-duration treatment approach.\n\nParticipants will receive sequential treatment with ibrutinib alone, followed by ibrutinib plus venetoclax, and then the triple combination of epcoritamab, venetoclax, and ibrutinib. The study will evaluate the effectiveness of this regimen, including the achievement of deep remission, as well as its safety and tolerability in this high-risk patient population.",[27,62],[109,256,547],"TP53 mutation","2026-07-30",{"date":550,"type":33},"2026-07-31",{"date":552,"type":21},"2026-12-31",{"date":554,"type":21},"2032-06-30",{"name":556,"class":122},"The Lymphoma Academic Research Organisation",29,{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":22,"phases":568,"briefSummary":569,"conditions":570,"keywords":574,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":585,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":592},"100194258","phase-3-a-long-term-extension-study-of-pci-32765-ibrutinib-100194258","NCT01804686","A Long-term Extension Study of PCI-32765 (Ibrutinib)","PCI-32765CAN3001: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study","CAN3001","Inclusion Criteria:\n\n* Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib\n* Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks\n* Agrees to protocol-defined use of effective contraception\n* Negative blood or urine pregnancy test at screening\n\nExclusion Criteria:\n\n* Requires anticoagulation with warfarin or equivalent vitamin K antagonists\n* Requires treatment with strong cytochrome P450 (CYP)3A4\u002F5 inhibitors, unless previously approved by sponsor\n* Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study",{"count":567,"type":21},700,[83],"The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.",[27,62,63,59,571,572,573],"Diffuse Large B-cell Lymphoma","Waldenstrom Macroglobulinemia","Chronic Graft Versus Host Disease",[575,576,577,578,579,580,581,582,583,584],"Chronic lymphocytic leukemia","Small lymphocytic lymphoma","Mantle cell lymphoma","Follicular lymphoma","Diffuse large B-cell lymphoma","PCI-32765","Ibrutinib","Bruton's tyrosine kinase inhibitor","IMBRUVICA","JNJ-54179060",{"date":550,"type":33},{"date":587,"type":33},"2013-09-09",{"date":589,"type":21},"2029-12-31",{"name":591,"class":40},"Janssen Research & Development, LLC",175,{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":17,"minAge":601,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":22,"phases":604,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":524,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":617,"locationsCount":333},"100649749","phase-2-study-of-zanubrutinib-in-older-patients-with-previously-untreated-chronic-lymphocytic-leukemia-cll-100649749","NCT07739459","Study of Zanubrutinib in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)","ZEN-CLL - A Phase II Trial Evaluating Zanubrutinib in Elderly, Treatment-Naïve, CLL Patients","ZEN-CLL","Inclusion Criteria:\n\n* Participant who understands and voluntarily signs and dates an informed consent form prior to any studyspecific assessments\u002Fprocedures being conducted, including consent for specific biology analysis\n* Must be able to adhere to the trial visit schedule and other protocol requirements\n* ≥ 80 years at the time of signing the informed consent form (ICF) with no upper age limit\n* Previously untreated and documented CLL or small lymphocytic lymphoma (SLL), with a Royal Marsden Hospital (RMH) or Matutes Score of 4 or 5. For SLL a detectable clone with a CLL phenotype in the peripheral blood is a prerequisite for trial participation.\n* Participant requiring treatment according to 2018 IWCLL guidelines\n* ECOG performance status 0 to 2\n* Life expectancy \\> 6 months\n* Adequate hematopoietic function within 7 days before the participant's enrollment\n\n  * ANC ≥ 0.75 G\u002FL\n  * And Platelets ≥ 50 G\u002FL Note: Platelets transfusions may be administered during screening to meet this requirement\n* Hemoglobin level \\> 9g\u002FdL, regardless of transfusion\n* Adequate renal function defined by a Creatinine Clearance ≥ 30 ml\u002Fmin calculated according to MDRD or CKD-EPI or Cockcroft-Gault (using actual body weight).\n* Adequate liver function, as indicated by a total bilirubin \\\u003C1.5 x ULN, AST and ALT \\\u003C3 x ULN value, unless directly attributed to the participant's CLL\u002FSLL or to Gilbert's Syndrome (the ULN is based on institutionalvalues)\n* Participant covered by any social security system\n* Participant who understands and speaks the country official language unless local regulation authorizes independent translator\n\nExclusion Criteria:\n\n* Any prior CLL or SLL-specific therapies, even including rituximab used for autoimmune cytopenias.\n* Clinically significant cardiovascular disease including the following:\n\n  1. Myocardial infarction within 6 months prior to ICF signature\n  2. Unstable angina within 3 months prior to ICF signature\n  3. NYHA class III or IV heart failure\n  4. Uncontrolled hypertension\n  5. History of clinically significant arrhythmias (including sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes).\n  6. History of Mobitz II second- or third-degree heart block without permanent pacemaker\n  7. Known LVEF \\\u003C50% as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan\n* Child-Pugh liver cirrhosis\n* Clinical evidence for Central Nervous System involvement by CLL\n* Severe chronic obstructive lung disease with hypoxemia\n* Severe diabetes mellitus\n* Disease significantly affecting gastrointestinal function (malabsorption syndrome, stomach or small bowel resection)\n* Active or non-active autoimmune hemolytic anemia (AIHA) (isolated positive DAT is not an exclusion criterion, but reticulocytes\u002Fhaptoglobin levels must be in lab normal ranges) or idiopathic thrombocytopenic purpura (ITP), requiring steroid therapy with \\> 20 mg daily of prednisone dose or equivalent.\n* Any prior history of Richter transformation or DLBCL\n* Any evidence or suspicion of Richter transformation or DLBCL during screening\n* Active malignancy other than the one treated in this trial. Prior history of malignancies unless the participant has been free of the disease for ≥ 2 years.\n\nHowever, participants with the following history \u002Fconditions that have been treated with a curative intent are allowed:\n\n1. Non-invasive basal cell or epidermoid carcinoma (non melanoma)\n2. In situ carcinoma of the cervix\n3. In situ carcinoma of the breast\n4. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis \\[TNM\\] clinical staging system\n5. Woman with adjuvant endocrine therapy (I.e., hormonotherapy) after breast cancer treatment can be enrolled if hormonotherapy was started for ≥ 2 years\n\n   * History of stroke or intracranial hemorrhage within 6 months prior to ICF signature.\n   * Major surgery 28 days before the ICF signature\n   * History or known bleeding disorders (e.g hemophilia or von Willebrand disease)\n   * Active Hepatitis C Virus (HCV) infection (RNA PCR-positive). Participants who received treatment for HCV infection that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable\n   * Active Hepatitis B Virus (HBV) infection (DNA PCR-positive). Participants with evidence of prior HBV infection but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy during the entire treatment with active monitoring of viral load in the blood\n   * Patient with a positive HIV test before enrollment are eligible provided that they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200\u002FuL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.Known or suspected hypersensitivity or anaphylaxis to trial intervention including active substance or to any of the excipients.\n   * Requires or receiving anticoagulation with warfarin or dual antiplatelets therapy equivalent vitamin K antagonists (other anticoagulants allowed: novel oral anticoagulant alone, aspirin alone, heparin alone).\n   * Requires treatment with a strong\u002Fmoderate cytochrome CYP3A4 inhibitor\u002Finducer.\n   * Participation in another clinical study who would compromise the participation to the current study.\n   * Vaccinated with live, attenuated vaccines within 6 months of ICF\n   * Use of any standard or experimental anti-cancer drug therapy within 28 days before the start (Day 1) of study treatment\n   * Corticosteroid use \\> 20 mg per day within 1 week before the first dose of trial intervention, except as indicated for other medical conditions, such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of trial intervention or contrast.\n   * Any significant medical conditions, or laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical trial or affect interpretation of trial outcomes (according to the investigator's decision)\n   * Any uncontrolled and\u002For active significant infection (eg, bacterial, viral, or fungal; including participants with positive cytomegalovirus PCR).\n   * Participant deprived of their liberty by a judicial or administrative decision\n   * Participant hospitalized without consent\n   * Adult participant under legal protection","80 Years",{"count":603,"type":21},95,[54],"This phase II, open-label, multicenter study evaluates zanubrutinib in patients aged 80 years and older with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who require treatment.\n\nCLL and SLL are slow-growing blood cancers that mainly affect older adults. Although zanubrutinib is an effective treatment, taking it continuously at the full dose may increase the risk of side effects over time, particularly in elderly patients. The study aims to assess whether a planned reduction in the dose of zanubrutinib after an initial period of treatment can maintain disease control while improving long-term tolerability.",[27,62],[575,576,608,609,610,611],"Zanubrutinib","BTK inhibitor","First-line treatment","Treatment-naïve patients","2026-07-28",{"date":550,"type":33},{"date":615,"type":21},"2026-12",{"date":37,"type":21},{"name":556,"class":122},{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":624,"targetDuration":4,"studyType":22,"phases":626,"briefSummary":627,"conditions":628,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":205},"100590453","phase-2-phase-ii-study-of-combined-pirtobrutinib-venetoclax-and-obinutuzumab-pvo-time-limited-treatment-for-patients-with-recurrent-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-cllsll-100590453","NCT06967610","Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL).","Eligibility Criteria:\n\n1. Age 18 years or older.\n2. Diagnosis of CLL\u002FSLL per 2018 iwCLL criteria (See Appendix 1).\n3. Participants with previously treated CLL requiring therapy based on 2018 iwCLL criteria.\n4. The participant is able to take oral medications.\n5. Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.\n6. Prior or ongoing therapy with covalent BTKi is allowed, but not required.\n7. Prior or ongoing therapy (at least for six months) with BCL2i is allowed, but not required. Prior therapy with combined BTKi and BCL2i or triplet BTKi, BCL2 and anti-CD20 mAb is allowed, but Participants need to be at least six months after completion of combination therapy. Participants with history of prior venetoclax therapy should have achieved at least a partial response or better while receiving venetoclax therapy.\n8. Participants are required to have the following washout periods prior to planned Cycle 1 Day1 (C1D1).\n\n   * Targeted agents, investigational agents, therapeutic monoclonal antibodies or cytotoxic chemotherapy: 5 half-lives or 2 weeks, whichever is shorter\n   * immunoconjugated antibody treatment within 10 weeks\n   * broad field radiation (≥ 30% of the bone marrow or whole brain radiotherapy) must be completed 14 days prior to enrollment\n   * palliative limited field radiation must be completed 7 days prior to enrollment\n9. Prior treatment-related AEs must have recovered to Grade ≤ 1 with the exception of alopecia and Grade 2 peripheral neuropathy.\n10. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.\n11. Participants must have adequate renal and hepatic function:\n\n    * Serum bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for Participants with Gilbert's disease or disease involvement by CLL\u002FSLL.\n    * Serum creatinine clearance of ≥30ml\u002Fmin (calculated or measured).\n    * ALT and AST ≤3.0 x ULN, unless clearly due to documented disease involvement, in which case ALT and AST ≤5.0 x ULN\n12. Adequate bone marrow function:\n\n    * Platelet count of ≥50,000\u002Fμl, with no platelet transfusion in prior 2 weeks.\n    * ANC ≥750\u002Fμl in the absence of growth factor support within 7 days of screening assessment.\n    * Hemoglobin ≥8g\u002FdL, independent of transfusions within 7 days of screening assessment. Please refer to Appendix 4 for details of adjustments of toxicities in participants with abnormal baseline values)\n13. Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time and prothrombin time (PT) or international normalized ratio (INR) not greater than 1.5 x ULN.\n14. Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test result at the time of screening and serum or urine β-hCG pregnancy test within 7 days prior to the first dose of study drugs and must agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices \\[IUDs\\], complete abstinence, or sterilized partner) and a barrier method (eg., condoms, vaginal ring, sponge, etc) during the period of therapy and for 6 months after the last dose of study drug (pirtobrutinib and Obinutuzumab) and 12 months after the last dose of obinutuzumab. Women of nonchildbearing potential are those who are postmenopausal (defined as absence of menses for ≥1 year) or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use effective contraception, defined above, during the study and for 30 days following the last dose of study drug\n\nExclusion Criteria:\n\n1. Participants who experienced progression of disease according to 2018 iwCLL criteria while on venetoclax will be excluded.\n2. Patient with prior history of Richter's syndrome or current Richter's Syndrome.\n3. Participants with known hypersensitivity to any of the excipients of pirtobrutinib, venetoclax,obinutuzumab or to any intended study medications.\n4. Known or suspected history of central nervous system (CNS) involvement by CLL\u002FSLL.\n5. History of bleeding diathesis.\n6. Participants who experienced a major bleeding event on a prior BTK inhibitor.• NOTE: Major bleeding is defined as bleeding having one or more of the following features: life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2 g\u002FdL; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome).\n7. History of stroke or intracranial hemorrhage within 6 months of enrollment.\n8. Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonists.\n9. Major surgery within 4 weeks of planned start of study therapy.\n10. A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disorder, that, in the opinion of the Investigator, would adversely affect the participant's participation in this study or interpretation of study outcomes.\n11. History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified Tcell (CAR-T) therapy within 60 days of enrollment or presence of any of the following, regardless of prior SCT and\u002For CAR-T therapy timing:\n\n    * active graft versus host disease (GVHD);\n    * cytopenia from incomplete blood cell count recovery post-transplant;\n    * need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity \\> Grade 1 from CAR-T therapy;\n    * ongoing immunosuppressive therapy (\\> 20 mg prednisone or equivalent daily).\n12. Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts.\n13. Participants who experienced grade \\>3 arrhythmia on prior treatment with BTK inhibitor.\n14. Significant cardiovascular disease, defined as any of the following:\n\n    1. Unstable angina or acute coronary syndrome within the past 2 months.\n    2. History of myocardial infarction within 6 months prior to planned start of study treatment.\n    3. Documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start of study treatment.\n    4. ≥ Grade 3 New York Heart Association (NYHA) functional classification system of heart failure.\n    5. uncontrolled or symptomatic arrhythmias\n15. Prolongation of the QT interval corrected (QTc - see Appendix 3) for heart rate using Fredericia's Formula (QTcF) \\> 470 msec on an EKG during screening.\n\n    1. QTcF is calculated using Fredericia's Formula (QTcF = QT\u002F(RR\\^0.33)\n    2. Correction of suspected drug-induced QTcF prolongation or prolongation due to electrolyte abnormalities can be attempted at the Investigator's discretion, and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation or electrolyte supplementation.\n    3. Correction of QTc for underlying bundle branch block (BBB) permissible. Participants with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker\n16. Hepatitis B or hepatitis C testing indicating active\u002Fongoing infection based on screening laboratory tests as defined as:\n\n    1. Hepatitis B virus (HBV): Participants with positive hepatitis B surface antigen (HBsAg) are excluded. Participants with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation. Participants who are hepatitis B PCR positive will be excluded.\n    2. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, participant will need to have a negative result for hepatitis C ribonucleic acid (RNA) . Participants who are hepatitis C RNA positive will be excluded.\n17. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, parasitic or fungal) or other clinically significant active disease process which in the opinion of the Principal Investigator may pose a risk for patient participation. Screening for chronic conditions is not required.\n18. Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count. For participants with unknown HIV status, HIV testing will be performed at screening and result must be negative for enrollment.\n19. Known active CMV infection. Participants with unknown or negative status are eligible.\n20. Vaccination with live vaccine within 28 days prior to enrollment\n21. Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the oral administered study treatments.\n22. Active other malignancy unless in remission and with life expectancy \\> 2 years. with exception of participants diagnosed with basal cell or squamous cell carcinoma of the skin or carcinoma \"in situ\" of the cervix or breast who are eligible even if diagnosed within 2 years. If Participants have another malignancy that was treated within the last 2 years, such participants may be enrolled, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer Center, and after consultation with the Principal Investigator.\n23. Current treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers. A washout period of at least 5 half-lives of these agents following discontinuation before study entry is required (treatment with moderate CYP3A4 inhibitors or inducers is not excluded). Because of their effect on CYP3A4, use of any of the following within 7 days of study therapy start or planned use during study participation is prohibited i. Grapefruit or grapefruit products ii. Seville oranges or products from Seville oranges iii. Star fruit.\n24. Current treatment with the following P-gp inhibitors: amiodarone, clarithromycin, cyclosporine, erythromycin, ketoconazole, and verapamil. A washout period of at least 5 half-lives of the inhibitor before study entry is required.\n25. Participants that are pregnant or plan to become pregnant during the study or within 1 month of the last dose of study treatment.\n\n25\\) Participants that are lactating or plan to breastfeed during the study or within 1 week of the last dose of study treatment.",{"count":625,"type":21},40,[54],"To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL\u002FSLL.",[27,629],"Small Lymphocytic Leukemia (SLL)",{"date":548,"type":33},{"date":632,"type":33},"2025-07-15",{"date":634,"type":21},"2033-06-01",{"name":636,"class":122},"M.D. Anderson Cancer Center",{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":438,"sex":17,"minAge":18,"maxAge":213,"enrollmentInfo":644,"targetDuration":4,"studyType":22,"phases":646,"briefSummary":647,"conditions":648,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":664},"100594521","phase-1-a-vaccine-cmv-mva-triplex-vaccine-for-the-enhancement-of-cmv-specific-immunity-and-the-prevention-of-cmv-viremia-in-patients-undergoing-haploidentical-hematopoietic-stem-cell-transplant-100594521","NCT07020533","A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant","A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n* DONORS: Documented informed consent of the participant. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* DONORS: Age: 18 - 75.\n* DONORS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* DONORS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and for up to 90 days post-vaccination.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n* RECIPIENTS: Documented informed consent of the participant and\u002For legally authorized representative. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* RECIPIENTS: Participant must be willing to comply with study and\u002For follow-up procedures, including willingness to be followed for one year post-HCT.\n* RECIPIENTS: Age: 18 - 75.\n* RECIPIENTS: Planned peripheral blood stem cell (PBSC) or bone marrow (BM) HCT for the treatment of the following hematologic malignancies:\n\n  * Lymphoma (Hodgkin and Non-Hodgkin).\n  * Myelodysplastic syndrome.\n  * Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia\u002Flymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography (CT) or CT\u002Fpositron emission tomography(PET) scan without progression is allowed.)\n  * Acute myeloid leukemia in first or second remission.\n  * Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase.\n  * Other hematologic malignancies judged appropriate by the clinical principal investigators (PIs), including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded\\*\\*.\n\n    * Adult cases of multiple myeloma (MM) are excluded as HCT is not standard of care for MM and is only performed in very advanced cases with an associated high risk of relapse and non-relapse mortality (NRM). Adults with aplastic anemia are excluded because their standard management includes T cell depletion with agents such as antithymocyte globulin (ATG), which is not permissible on this protocol. Patients undergoing a second haploHCT are not eligible (patients who have undergone a previous autologous HCT are eligible).\n* RECIPIENTS: Patients receiving myeloablative (MA) or reduced intensity conditioning (RIC) are allowed.\n* RECIPIENTS: CMV seropositive.\n* RECIPIENTS: Eligible haploidentical donors will have 2-4 mismatches if human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 typing is used; 2-5 mismatches if HLA-A, -B, -C, -DRB1, and -DQB1 typing is used; and 2-6 mismatches if HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 typing is used. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must demonstrate that they are a full haplotype match by being identical at a minimum of one allele (at high resolution deoxyribonucleic acid \\[DNA\\]-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1 if 8 allele typing is used; HLA-A, -B, -C, -DRB1, and -DQB1 if 10 allele typing is used; and HLA-A, -B, -C, -DRB1-, DQB1, and -DPB1 is 12 allele typing is used.\n* RECIPIENTS: Planned HCT with minimal to no-T cell depletion of graft.\n* RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted.\n* RECIPIENTS: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Estimated creatinine clearance acceptable per institutional guidelines (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n  * Note: To be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).\n\n  * If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air.\n  * Note to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combination (combo), hepatitis c virus (HCV)\\*, active hepatitis b virus (HBV) (surface antigen negative) and syphilis (RPR) within 2 months of registration and no history of disseminated cutaneous human papillomavirus (HPV) related disease.\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n* RECIPIENTS: Meets other institutional and federal requirements for infectious disease titer requirements.\n\n  * Note Infectious disease testing to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and up to 90 days post-HCT.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* DONORS: Any prior transplant to day 1 of protocol therapy (day 1 defined as the day after donors receive the Triplex vaccine).\n* DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.\n* DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after the study vaccine.\n* DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension.\n* DONORS: Sickling hemoglobinopathy including hemoglobin (Hb)SS, HbAS, HbSC.\n* DONORS: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes) are ineligible for Triplex vaccination.\n* DONORS: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely and making informed consent impossible.\n* DONORS: Females only: Pregnant or breastfeeding.\n* DONORS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* DONORS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).\n* RECIPIENTS: Any prior investigational CMV vaccine.\n* RECIPIENTS: Experimental anti-CMV chemotherapy in the last 6 months.\n* RECIPIENTS: Live attenuated vaccines (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Allergy treatment with antigen injections (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent (or CD34+ selection) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)\u002Fvalganciclovir (VAL), foscarnet (FOS), cidofovir, CMX-001, maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment EXCEPT letermovir prophylaxis (prior to day 100) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Disease-based radiation therapy (not total body irradiation) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other investigational product(s) - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years.\n* RECIPIENTS: Patients considered by PI\u002Fconsenting physicians to have a complicated prior therapy or HCT regimen, or who have a low survival probability (e.g., refractory leukemia and\u002For undergoing 2nd HCT).\n* RECIPIENTS: Poor risk disease\u002Fdisease status including: Chronic myelogenous leukemia (CML) in blast crisis, acute myeloid leukemia (AML)\u002Facute lymphoblastic leukemia (ALL) beyond 2nd remission, multiple myeloma, and aplastic anemia.\n* RECIPIENTS: Females only: Pregnant or breastfeeding.\n* RECIPIENTS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* RECIPIENTS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":645,"type":21},46,[53],"This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and\u002For effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.",[649,220,219,27,650,651,652,653,221,654,655,60],"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lymphoblastic Lymphoma","Myelofibrosis","Myeloproliferative Neoplasm","2026-07-27",{"date":612,"type":33},{"date":659,"type":33},"2026-05-08",{"date":661,"type":21},"2029-05-30",{"name":663,"class":122},"City of Hope Medical Center",3,{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":670,"acronym":4,"eligibilityCriteria":671,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":672,"targetDuration":4,"studyType":22,"phases":674,"briefSummary":675,"conditions":676,"keywords":4,"overallStatus":524,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":205},"100649407","phase-2-venetoclax-plus-zanubrutinib-for-the-treatment-of-chronic-lymphocytic-leukemia-and-small-lymphocytic-lymphoma-100649407","NCT07734038","Venetoclax Plus Zanubrutinib for the Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma","A Phase Two Study of Venetoclax Plus Zanubrutinib in Newly Diagnosed CLL and After Front-Line Time-Limited Venetoclax-Based Therapy","Inclusion Criteria:\n\n* Diagnosis of CLL\u002FSLL meeting criteria established in International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria\n* Age ≥ 18 years\n* Indications for treatment as defined by the iwCLL 2018 Guidelines\n* Received prior treatment or not depending on cohort\n\n  * Frontline cohort:\n\n    * CLL\u002FSLL who are treatment-naïve and have met criteria 1 through 3 above\n  * Second line cohort:\n\n    * Must have received time-limited venetoclax based therapy in the front line. This is defined as treatment with venetoclax and an-anti-CD20 antibody, venetoclax and a BTKi, or treatment with venetoclax and a BTKi, and an anti-CD20 monoclonal antibody that was given for a fixed-duration. Patients who discontinue ibrutinib, due to intolerance, in a BTKi and venetoclax +\u002F- obinutuzumab combination are eligible provided they completed other drugs in the regimen and in the opinion of the treating investigator the intolerance will not limit treatment with zanubrutinib and venetoclax. Patients who discontinued BTKi other than ibrutinib or who discontinued venetoclax due to intolerance will be excluded\n    * At least 2 years since completion of initial CLL treatment\n    * Only 1 prior line of therapy. Treatment with rituximab or other anti-CD20 monoclonal antibody for idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA) is not considered a prior line of CLL\u002FSLL therapy\n* Eastern Cooperative Oncology Group (ECOG) performance 0-2\n* Absolute neutrophil count (ANC) \\> 1000\u002Fmm\\^3 (independent of growth factor support at screening, unless cytopenias are due to marrow involvement by CLL\u002FSLL)\n* Platelets \\> 30,000\u002Fmm\\^3 at screening (independent of growth factor support at screening, unless cytopenias are due to marrow involvement by CLL\u002FSLL)\n* Hemoglobin \\> 7 g\u002FdL (independent of growth factor support at screening, unless cytopenias are due to marrow involvement by CLL\u002FSLL)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x the upper limit of normal (ULN) or ≤ 5 x ULN with documented liver involvement\n* Bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN with documented liver involvement and\u002For Gilbert's disease\n* Creatinine clearance (CrCl) ≥ 50 according to modified Cockcroft-Gault equation\n* Willing and able to complete study activities and treatment\n* Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n* Willingness of men and women of reproductive potential and their partners to observe conventional and highly effective or acceptable birth control methods for the duration of treatment and for 1 week following the last dose of zanubrutinib or 30 days following the last dose of venetoclax, whichever is longer\n\nExclusion Criteria:\n\n* Second line arm only: Patients who progressed per iwCLL 2018 criteria on therapy or within two years of completing time-limited, venetoclax based treatment\n* Frontline arm only: Patients with deletion 17p and\u002For TP53 mutation\n* Active Richter's transformation\n* Prior zanubrutinib exposure\n* Known hypersensitivity to any of the excipients of zanubrutinib or venetoclax\n* Need for treatment with warfarin or other vitamin K antagonist during study treatment\n* History of stroke or intracranial hemorrhage within 6 months\n* Known bleeding diathesis\n* Inability to take pills or oral medications\n* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of either zanubrutinib or venetoclax\n* Active second malignancy unless in remission and with life expectancy \\> 2 years. Adjuvant endocrine therapy for breast or prostate cancer that is expected to be cured is allowed. Non-melanoma skin cancers are permitted if adequately treated\n* Psychiatric illness, or social situations that would limit compliance with study requirements\n* Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts\n* Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator may pose a risk for patient participation. Screening for chronic conditions is not required\n* Significant cardiovascular disease defined as:\n\n  * Unstable angina or acute coronary syndrome within the past 2 months\n  * History of myocardial infarction within 3 months\n  * Documented left ventricular ejection fraction (LVEF) by any method of ≤ 40% within 12 months\n  * ≥ grade 3 New York Heart Association (NYHA) functional classification system of heart failure\n  * Uncontrolled or symptomatic arrhythmias\n\n    * Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker\n* Prolongation of the QT interval corrected for heart rate (QTcF) \\> 470 msec. QTcF is calculated using Fridericia's Formula (QTcF)\n\n  * Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation\n  * Correction for underlying bundle branch block (BBB) allowed\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:\n\n  * Hepatitis B virus (HBV): Patients with positive hepatitis B surface antibody (HBsAb) are not excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before inclusion. Patients who are hepatitis B PCR positive at time of screening will be excluded. Those who have hepatitis B core antibody positive and a negative PCR will be included if they are agreeable to receive antiviral prophylaxis\n  * Hepatitis C virus (HCV): If hepatitis C antibody is positive, patients will need to have a negative result for hepatitis C ribonucleic acid (RNA) before inclusion. Patients who are hepatitis C RNA positive at time of screening will be excluded. Patients previously treated for hepatitis C \\> 6 months previously with a negative RNA test are eligible\n  * Patients who are receiving intravenous immunoglobulin (IVIG) who test positive for any hepatitis B or C serologies and have a negative PCR and who are deemed likely to have received antibodies passively through IVIG and not from prior infection will be included without viral prophylaxis\n* Treatment with a strong cytochrome P450 (CYP)3A inhibitor or inducer and\u002For strong P-glycoprotein (P-gp) inhibitors within 3 days of starting and during study treatment\n* Patients may not plan to consume grapefruit or grapefruit products, Seville oranges or products from Seville oranges, or star fruit\n* Pregnancy, lactation, or plan to breastfeed during treatment with or within 2 weeks of the last dose of zanubrutinib or 1 month of the last dose of venetoclax\n* Major surgery within 4 weeks prior to screening\n* Vaccination with live vaccine within 28 days of screening\n* Currently incarcerated\n* Current central nervous system involvement by CLL\u002FSLL",{"count":673,"type":21},155,[54],"This phase II trial tests the effect of venetoclax in combination with standard of care (SOC) zanubrutinib in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. It is a type of tyrosine kinase inhibitor. Giving venetoclax in combination with SOC zanubrutinib may be safe and tolerable and may reduce the number of cancer cells that remain in the body in patients with CLL or SLL that have not previously received treatment or at least two years have passed since completing initial treatment.",[27,62],"2026-07-24",{"date":679,"type":33},"2026-07-29",{"date":681,"type":21},"2026-10-07",{"date":683,"type":21},"2027-12-31",{"name":685,"class":122},"Kerry Rogers",{"id":687,"slug":688,"hasResults":12,"nctId":689,"briefTitle":690,"officialTitle":691,"acronym":4,"eligibilityCriteria":692,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":693,"targetDuration":4,"studyType":22,"phases":694,"briefSummary":695,"conditions":696,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":702,"completionDateStruct":704,"leadSponsor":706,"locationsCount":205},"100582445","phase-2-nemtabrutinib-and-pembrolizumab-for-the-treatment-of-richter-transformation-diffuse-large-b-cell-lymphoma-subtype-100582445","NCT06863402","Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype","Nemtabrutinib and Pembrolizumab in Patients With Richter Transformation: A Phase II Study","Inclusion Criteria:\n\n* Patients with biopsy-proven Richter transformation, diffuse large B-cell lymphoma subtype (RT-DLBCL) from an antecedent or concurrently diagnosed chronic lymphocytic leukemia (CLL) and\u002For small lymphocytic lymphoma (SLL).\n* Be ineligible for frontline anthracycline-based chemoimmunotherapy (determined by treating investigator) OR have clinical evidence of disease progression after any prior treatment for RT-DLBCL.\n* Participants who have adverse events (AEs) due to previous anti-cancer therapies must have recovered to ≤ grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤ grade 2 neuropathy are eligible.\n\n  * Note: Participants who have lingering cytopenias from prior anti-cancer therapy or progressive disease may be eligible at the discretion of the study principal investigator (PI), provided they meet all other study criteria.\n* Have measurable disease as determined by imaging (by positron-emission tomography \\[PET\\] and\u002For computed tomography \\[CT\\] scans), immunohistochemistry, and\u002For flow cytometry, as per the Cheson criteria.\n* Have the ability to swallow and retain oral medication.\n* Age 18 years and older on the day of signing informed consent.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Be free from other malignancy within 2 years prior to enrollment (with the exception of CLL\u002FSLL, low-risk and early stage \\[T1-T2a- Gleason score ≤ 6, and prostate-specific antigen \\[PSA\\] \\\u003C 10 ng\u002FmL\\] prostate cancer, or localized skin cancer that has undergone potentially curative therapy).\n* Absolute neutrophil count: ANC ≥ 500 cells\u002FµL (without G-CSF dose within the last 7 days prior to initiation of study treatment\n* Platelets: ≥ 25,000\u002FµL -not requiring transfusion within the last 3 days prior to initiation of study treatment). Patients on medications that increase bleeding risk (e.g. systemic anticoagulation, anti-platelet therapies, etc.) must have a platelet count ≥50,000 \u002FµL and have no history of major bleeding.\n* Hemoglobin: ≥ 7gm\u002FdL (transfusion support allowed).\n* Total bilirubin: ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 x ULN.\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase \\[SGPT\\]): ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastases).\n* Creatinine clearance (CrCl): ≥ 30 mL\u002Fmin (per Cockroft-Gault equation).\n* International normalized ratio (INR) (prothrombin \\[PT\\]\u002Factivated partial thromboplastin time \\[aPTT\\]): ≤ 1.5 x ULN, unless participant is receiving anticoagulant therapy, as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n* Patients with history of human immunodeficiency virus (HIV) infection are potentially eligible (after conferring with the PI) if they meet ALL of the following criteria:\n\n  * Must have a CD4+ T-cell count ≥ 350 cells\u002Fmm\\^3 AND an HIV viral load below the detectable level as per locally available testing at the time of screening\n  * It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  * Participants on anti-retroviral therapy (ART) must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (day 1) and agree to continue ART throughout the study.\n  * The combination ART regimen must not contain any antiretroviral medications that interact with strong CYP3A4 inhibitors\u002Finducers\u002Fsubstrates (\\\u003Chttps:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers\\>). Participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study.\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n\nNote: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Hepatitis B screening tests, including HBsAg and hepatitis B core antibodies (anti-HBc), are required for all participants.\n\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening (Participants must have completed curative anti-viral therapy at least 4 weeks prior to the first administration of the study treatment).\n* A person of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Participants of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Should a person of child-bearing potential become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform their treating physician immediately.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).\n* Has received prior systemic anti-cancer therapy within 5 half-lives or 14 days, whichever is lesser (or within 30 days for cellular therapy or investigational agents, or within 100 days post allogeneic hematopoietic stem cell transplantation and without any grade ≥ 2 graft versus host disease) prior to enrollment.\n* Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-central nervous system (CNS) disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed or messenger ribonucleic acid (mRNA) vaccines is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (daily dose exceeding 10 mg of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. Has severe hypersensitivity (≥ grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has severe hypersensitivity (≥ grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid allowed).\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patients with pathologically confirmed Hodgkin-like RT (RT-classical Hodgkin's lymphoma \\[cHL\\]).\n* Estimated life expectancy of \\\u003C 1 month as determined by the treating investigator.\n* Uncontrolled active illness including but not limited to heart failure, unstable ischemic heart disease, arrhythmia, psychiatric illness, acute renal failure, and any other conditions that would reasonably be expected to limit compliance with the study protocol.\n* Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV deoxyribonucleic acid \\[DNA\\]) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n* Corrected QT interval (QTc) prolongation (defined as a Fridericia's corrected QT \\[QTcF\\] \\> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats\u002Fmin).\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Unwilling or unable to follow protocol requirements.\n* Received any other investigational agent within 30 days prior to enrollment.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For multicentric Castleman's disease.\n* History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding.NOTE: Patients on active anti-coagulation, anti-platelet therapies, and other medications that may increase bleeding risks may be allowed on study, permitted that these potentially interacting drugs may be safely held in the setting of thrombocytopenia, and at the discretion of the treating investigator and with close monitoring.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has had an allogeneic tissue\u002Fsolid organ transplant. Note: Patients with prior allogeneic hematopoietic stem cell transplant or allogeneic cellular therapy are allowed, provided they meet they meet the washout period.\n* Use of medications that are strong CYP3A4 inhibitors or inducers or P-gp and\u002For BCRP substrates with a narrow therapeutic index within 14 days prior to first dose of study treatment or 5 half-lives of the given drug, whichever is longer",{"count":409,"type":21},[54],"This phase II trial tests how well nemtabrutinib in combination with pembrolizumab works in treating patients with Richter transformation, diffuse large B-cell lymphoma subtype (RT-DLBCL). Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cells (a type of white blood cell) in cancers such as Richter transformation at abnormal levels. This may help keep cancer cells from growing and spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving nemtabrutinib in combination with pembrolizumab may kill more cancer cells in patients with RT-DLBCL.",[697,698,27],"Richter Syndrome","Diffuse Large B-Cell Lymphoma","2026-07-17",{"date":701,"type":33},"2026-07-20",{"date":703,"type":21},"2026-08-15",{"date":705,"type":21},"2030-06-01",{"name":707,"class":122},"Roswell Park Cancer Institute"]