[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jennifer Woyach\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100647005","phase-2-pirtobrutinib-for-the-treatment-of-elderly-patients-with-chronic-lymphocytic-leukemia-100647005",false,"NCT07685717","Pirtobrutinib for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia","A Phase 2 Trial of Single-Agent Pirtobrutinib for Elderly Patients With CLL","Inclusion Criteria:\n\n* Men and women ≥ 75 years of age\n* Diagnosis of CLL\u002Fsmall lymphocytic lymphoma (SLL) meeting criteria established in the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines\n* Must be treatment-naive: Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control. For radiation, broad field radiation (≥ 30% of bone marrow or whole brain radiotherapy) must be completed 14 days before study enrollment; palliative limited field radiation must be completed 7 days prior to study enrollment. For rituximab, washout of 2 weeks is required prior to study enrollment\n* Must require treatment according to 2018 iwCLL guidelines\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy\n* Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN with documented liver involvement and\u002For Gilbert's syndrome\n* Creatinine clearance ≥ 30 mL\u002Fminute using Cockcroft-Gault formula\n* Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin time (PT) or (international normalized ratio \\[INR\\]) not greater than 2.0 × ULN\n* Absolute neutrophil count (ANC) ≥ 0.75 x 10\\^9 (on or within 7 days of cycle 1 day 1 \\[C1D1\\] before treatment); the patient may enroll below threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis. Granulocyte colony-stimulating factor (GCSF) support is allowed\n* Platelet count ≥ 30 x 10\\^9 not requiring transfusion support (on or within 7 days of C1D1 before treatment); the patient may enroll below this threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis\n* Hemoglobin ≥ 6 mg\u002FdL not requiring transfusion support or growth factors (on or within 7 days of C1D1 before treatment); the patient may enroll below this threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis\n* If patients require transfusion support due to bone marrow involvement of CLL, they must be responsive to transfusion support\n* Male patients are sexually active with a woman of childbearing potential must use highly effective methods of contraception during treatment\n* The patient is able to take oral medications\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information\n\nExclusion Criteria:\n\n* Active Richter's transformation (i.e. within 6 months of active therapy, or requiring treatment for Richter's transformation)\n* Malabsorption syndrome or inability to absorb pirtobrutinib\n* Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, those with uncontrolled arrhythmia, and those patients who experienced an myocardial infarction (MI) within 3 months of screening or acute coronary syndrome within 2 months of screening are not eligible\n* Documented left ventricular ejection fraction (LVEF) by any method of ≤ 40% in the 12 months prior to randomization\n* Prolongation of QT interval corrected for heart rate (QTcF) \\> 470 msec\n* Major surgical procedure within 28 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug\n* Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)\n* History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug\n* Patients who have tested positive for human immunodeficiency virus (HIV) are excluded due to risk of opportunistic infections with both HIV and Bruton Tyrosine Kinase (BTK)-inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrollment\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:\n\n  * Hepatitis B virus (HBV):\n\n    * Patients with positive hepatitis B surface antigen (HBsAg) are excluded\n    * Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require a negative hepatitis B polymerase chain reaction (PCR) evaluation before starting study therapy\n    * Patients who are HBV deoxyribonucleic acid (DNA) PCR positive will be excluded\n  * Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded\n* Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible\n* Evidence of other clinically significant uncontrolled condition(s) including but not limited to: uncontrolled systemic 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* Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)\n* Active second malignancy unless in remission and with life expectancy \\> 2 years\n* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists\n* Vaccination with live vaccines 28 days prior to registration for study screening\n* Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components","ALL","75 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies how well pirtobrutinib works in treating elderly patients with chronic lymphocytic leukemia (CLL). Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib work by blocking the action of the BTK protein that signals cancer cells to multiply. These are very effective, tolerable, and commonly used to treat people with CLL, but they may lead to drug resistance over time. Pirtobrutinib, also a BTK inhibitor, may work better in treating elderly patients with CLL.",[26],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","RECRUITING","2026-06-29",{"date":30,"type":31},"2026-07-06","ACTUAL",{"date":33,"type":20},"2026-08-01",{"date":35,"type":20},"2027-12-31",{"name":37,"class":38},"Jennifer Woyach","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":61,"locationsCount":39},"100635774","phase-2-nemtabrutinib-and-venetoclax-for-the-treatment-of-patients-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-100635774","NCT07557056","Nemtabrutinib and Venetoclax for the Treatment of Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","A Phase 2 Study of Nemtabrutinib and Venetoclax as Frontline Treatment for Chronic Lymphocytic Leukemia (CLL)","Inclusion Criteria:\n\n* Confirmed diagnosis of CLL\u002FSLL meeting criteria established in the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines\n* Is an individual of any sex\u002Fgender, who is at least 18 years of age on the day of signing informed consent\n* Participants must have treatment-naïve CLL\u002FSLL. Palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptom control will not be considered prior therapy\n* Participants must meet criteria for treatment as defined by 2018 iwCLL guidelines which includes at least one of the following criteria:\n\n  * Massive (\\>= 6 cm below the costal margin), progressive or symptomatic splenomegaly\n  * Massive nodes (\\>= 10 cm) or progressive or symptomatic lymphadenopathy\n  * Progressive lymphocytosis with a lymphocyte doubling time \\\u003C 6 months or an increase of \\>= 50% over a 2 month period\n  * Autoimmune anemia and\u002For thrombocytopenia that is poorly responsive to standard therapy\n  * Symptomatic or functional extranodal involvement (e.g. skin, kidney, lung, spine)\n  * Constitutional symptoms, which include any of the following:\n\n    * Unintentional weight loss of 10% or more within 6 months\n    * Significant fatigue\n    * Fevers \\> 100.5 degrees Fahrenheit (F) for 2 weeks or more without evidence of infection\n    * Night sweats \\>= 1 month without evidence of infection\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention\n* Adequate bone marrow independent of growth factor support or infusion support at screening unless evidence shows that the cytopenia(s) is due to marrow involvement by CLL\u002FSLL and\u002For disease-related immune thrombocytopenia, or anemia. If cytopenias are due to disease in the bone marrow any degree of cytopenias are allowed. Patients with active uncontrolled autoimmune cytopenias are excluded\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3\n* Platelets \\>= 50,000\u002Fmm\\^3\n* Hemoglobin \\>= 8 g\u002FdL\n* Willing and able to participate in all required evaluations and procedures in this study protocol\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information\n* Participants assigned male sex at birth: If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n\n  * Nemtabrutinib: 12 days\n  * Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR\n  * Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:\n  * Uses a penile\u002Fexternal condom plus nonparticipant of childbearing potential who is not currently pregnant and should also be advised of the benefit for that partner to use an additional method of contraception, as a condom may break or leak.\n\n    * Note: Participants capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use penile\u002Fexternal condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate.\n  * Contraceptive use by participants capable of producing sperm should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed\n* Participants assigned female sex at birth: A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a person of childbearing potential (POCBP) OR\n  * Is a POCBP and:\n\n    * Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n\n      * Nemtabrutinib: 1 month\n    * The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n    * Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for urine test) or 72 hours (for serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n    * Abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention with nemtabrutinib.\n    * Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy\n* The ability to swallow and retain oral medication.\n\n  * NOTE: Administration of nemtabrutinib is not permitted through a percutaneous endoscopic gastro-jejunostomy (J-PEG) tube\n* Participants who are hepatitis B surface antigen (HbsAg) positive are eligible if they have received hepatitis B viral (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to screening.\n\n  * Note: 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 anti-HBc (hepatitis B core), are required for all participants\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\n  * Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n  * Hepatitis C screening tests are not required unless:\n\n    * Known history of HCV infection\n    * As mandated by local health authority\n* Participants with human immunodeficiency virus (HIV) are eligible if they meet ALL of the following criteria:\n\n  * The CD4 count is \\> 350 cells\u002FìL at screening\n  * The HIV viral load is below the detectable level as per locally available testing\n  * Are on a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior to study entry\n  * NOTE: ART includes drugs, which are NOT strong CYP3A4 inducers (participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study).\n  * HIV screening tests are not required unless:\n\n    * Known history of HIV infection\n    * As mandated by local health authority\n  * Are compliant with their ART\n  * NOTE: If the participant has had an acquired immunodeficiency syndrome (AIDS) defining opportunistic infection in the past 12 months prior to screening, they are not eligible to be included in the study\n* Absolute neutrophil count (ANC) \\>= 1000\u002FuL\n\n  * Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed.\n  * No lower limit if cytopenia is related to bone marrow involvement\n* Platelets \\>= 50000\u002FuL\n\n  * Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed.\n  * No lower limit if cytopenia is related to bone marrow involvement\n* Hemoglobin \\>= 8 g\u002FdL\n\n  * Growth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed.\n  * No lower limit if cytopenia is related to bone marrow involvement\n* Creatinine clearance (CrCl) \\>= 30mL\u002Fmin\n* Total bilirubin ≤ 1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x ULN (=\\\u003C 5 x ULN for participants with liver metastases)\n* International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants\n\nExclusion Criteria:\n\n* Subject with other malignancies that are associated with a life expectancy of \\\u003C 2 years or that would confound assessment of toxicity in this study.\n\n  * NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder\n* Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled atrial fibrillation can enroll on study\n* Active HBV\u002FHCV infection\n* Inability to swallow oral medication or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy)\n* Diagnosis of Richter transformation\n* Active central nervous system (CNS) involvement\n* Active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening. Participants may be rescreened followed completion of IV antibiotic course\n* AIDS defining opportunistic infection in the past 12 months prior to screening\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n* Corrected QT (QTc) prolongation (defined as a Fridericia-corrected QT interval \\[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* Known allergy\u002Fsensitivity (\\>= grade 3) to nemtabrutinib or any of the excipients.\n\n  * NOTE: Refer to the investigator brochure (IB) for details regarding excipients for nemtabrutinib\n* History of severe bleeding disorders\n* A POCBP who has a positive urine pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n\n  * Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication\n* Prior CLL\u002FSLL directed therapy\n* Currently being treated with the following drugs:\n\n  * P-glycoprotein (P-gp) substrates with a narrow therapeutic index\n  * CYP3A strong inducers\n  * CYP3A strong inhibitors\n  * NOTE: A washout period of at least 5 times the half-life after the last dose of any of the above treatments is required for a participant to be eligible for study enrollment. A list of example in vivo substrates for specific CYP enzymes and P-gp is provided\n  * NOTE: Refer to protocol regarding prohibited concomitant medications and potential drug interactions after participant randomization\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (if prior therapy was a monoclonal antibody) or 5 half-lives before randomization (whichever is longer)\n* Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids\n\n  * Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n\n  * Note: please refer to protocol for information on COVID-19 vaccines\n* Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\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)\n* Has an active infection requiring systemic therapy\n* Has not adequately recovered after 4 weeks from major surgery or has ongoing surgical complications.\n\n  * Note: Biopsy and placement of central venous access devices are not considered major surgery\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial","18 Years",{"count":49,"type":20},25,[23],"This phase II trial tests how well nemtabrutinib and venetoclax work in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 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 CLL or SLL at abnormal levels. This may help keep cancer cells from growing and spreading. 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. Giving nemtabrutinib in combination with venetoclax may kill more cancer cells in patients with CLL or SLL.",[53,54],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","NOT_YET_RECRUITING",{"date":57,"type":31},"2026-07-01",{"date":59,"type":20},"2026-09-01",{"date":35,"type":20},{"name":37,"class":38},""]