[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nodal-peripheral-t-cell-lymphoma-with-tfh-phenotype\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nodal-peripheral-t-cell-lymphoma-with-tfh-phenotype":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,100],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100424154","phase-2-testing-the-addition-of-duvelisib-or-cc-486-to-the-usual-treatment-for-peripheral-t-cell-lymphoma-100424154",false,"NCT04803201","Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma","A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) with \\\u003C 10% CD30 expression by immunohistochemistry in the following subtypes (by local review): nodal T-cell lymphoma with T-follicular helper (TFH) phenotype (TFH-PTCL), follicular T-cell lymphoma, PTCL-not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), enteropathy associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma\n\n  * Patients with expression of CD30 in \\>= 10% of the tumor (based on local immunohistochemistry review) regardless of histology will not be permitted\n  * Patients with a diagnosis of other PTCL subtype histologies other than those specified in the inclusion criteria are excluded including large cell transformation of mycosis fungoides\n  * Patients will be stratified by presence or absence of TFH phenotype (i.e. diagnosis of AITL, TFH-PTCL, follicular T-cell lymphoma) based on local review of pathology. Determination of TFH phenotype can be defined by expression of two or more of the following markers CD10, BCL6, CXCL13, ICOS, and PD1 by immunohistochemistry\n* Measurable disease as defined by the Lugano criteria\n* No prior systemic therapy for lymphoma (excluding corticosteroids)\n* Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\\\u003C 7 days prior to registration is required\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Platelet count \\>= 75,000\u002Fmm\\^3 (\\>= 50,000\u002Fmm\\^3 if secondary to bone marrow involvement from lymphoma per investigator assessment; the first 12 patients on each arm of the study must have platelets \\>= 75,000\u002Fmm\\^3 regardless of bone marrow involvement)\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3\n* Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)\u002Fserum glutamate pyruvate transaminase (SGPT) =\\\u003C 3.0 x upper limit of normal (ULN)\n\n  \\* Except in subjects with documented liver involvement by lymphoma\n* Calculated creatinine clearance \\>= 30 mL\u002Fmin by Cockcroft-Gault formula\n* Total bilirubin =\\\u003C 2.0 x ULN\n\n  \\* Except in cases of Gilbert's Syndrome or documented liver or pancreatic involvement by lymphoma\n* Archival tissue must be available for submission\n* Patients known to have HTLV 1\u002F2 are excluded\n* Patients with known central nervous system involvement are excluded\n* No active viral infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Those who are seropositive (e.g. hepatitis B core antibody \\[Ab\\] positive) are permitted if they are negative by polymerase chain reaction (PCR). Those who are seropositive for hepatitis B and are negative for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) by PCR must receive concomitant hepatitis B directed antiviral therapy. Those who have hepatitis C Ab positivity who have completed curative therapy for hepatitis C with negative hepatitis C PCR are eligible\n* Patients with history of HIV are eligible if they have an undetectable viral load for at least 6 months\n* No active uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and\u002For other treatment). Patients with Epstein-Barr virus (EBV) viremia related to their lymphoma are permitted\n* No concurrent malignancy requiring active therapy within the last 3 years with the exception of basal cell carcinoma limited to the skin, squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix, breast or localized prostate cancer. Adjuvant hormonal therapy for cancer previously treated for curative intent is permitted\n* Patients must have documented left ventricular ejection fraction of \\>= 45%\n* No significant active cardiac disease within the previous 6 months including:\n\n  * New York Heart Association (NYHA) class III or IV congestive heart failure\n  * Unstable angina or angina requiring surgical or medical intervention; and\u002For\n  * Myocardial infarction\n* No contraindication to any drug in the chemotherapy regimen, including neuropathy \\>= grade 2\n* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment","ALL","18 Years",{"count":19,"type":20},170,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help find out if this approach is better or worse than the usual approach for treating peripheral T-cell lymphoma.",[26,27,28,29,30,31,32],"Angioimmunoblastic T-cell Lymphoma","Enteropathy-Associated T-Cell Lymphoma","Follicular T-Cell Lymphoma","Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma","Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma","Nodal Peripheral T-Cell Lymphoma With TFH Phenotype","Peripheral T-Cell Lymphoma, Not Otherwise Specified","RECRUITING","2026-08-18",{"date":36,"type":37},"2026-08-19","ACTUAL",{"date":39,"type":37},"2021-10-08",{"date":41,"type":20},"2027-05-19",{"name":43,"class":44},"Alliance for Clinical Trials in Oncology","OTHER",96,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":55,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100514411","a-registry-for-people-with-t-cell-lymphoma-100514411","NCT05978141","A Registry for People With T-cell Lymphoma","The T-cell Lymphoma Master Repository (TCLMR): A Prospective Databank of Patients With T-cell Lymphoma With Clinical Annotation and Matched Tumor Specimens","Inclusion Criteria:\n\n* Written informed consent\n* Adequate fresh or archival tumor biopsy or intent to obtain fresh tumor biopsy.\n* Pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma meeting one of the following diagnostic criterion (based on WHO classification and NCCN guidelines):\n\n  * T-cell prolymphocytic leukemia\n  * T-cell large granular lymphocytic leukemia\n  * Chronic lymphoproliferative disorder of NK cells\n  * Aggressive NK-cell leukemia\n  * Systemic Epstein-Barr virus (EBV)-positive T-cell lymphoma of childhood\n  * Chronic active EBV infection of T- and NK-cell type, systemic form\n  * Hydroa vacciniforme-like lymphoproliferative disorder\n  * Adult T-cell leukemia\u002Flymphoma\n  * Extranodal NK\u002FT-cell lymphoma, nasal type\n  * Enteropathy-associated T-cell lymphoma\n  * Monomorphic epitheliotropic intestinal T-cell lymphoma\n  * Intestinal T-cell lymphoma, not otherwise specified (NOS)\n  * Indolent T-cell lymphoproliferative disorder of the gastrointestinal tract\n  * Hepatosplenic T-cell lymphoma\n  * Subcutaneous panniculitis-like T-cell lymphoma\n  * Mycosis fungoides (limited to those with ≥ stage IB disease and those receiving active therapy)\n  * Sézary syndrome\n  * Primary cutaneous anaplastic large cell lymphoma (receiving systemic therapy)\n  * Primary cutaneous Gamma-Delta T-cell lymphoma\n  * Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma\n  * Primary cutaneous acral CD8+ T-cell lymphoma (receiving systemic therapy)\n  * Peripheral T-cell lymphoma, not otherwise specified\n  * Angioimmunoblastic T-cell lymphoma\n  * Follicular T-cell lymphoma\n  * Nodal peripheral T-cell lymphoma with TFH phenotype\n  * Anaplastic large cell lymphoma, ALK-positive\n  * Anaplastic large cell lymphoma, ALK-negative\n  * Breast-implant associated anaplastic large cell lymphoma.\n* NOTE: Patients with diagnoses of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma must be receiving systemic therapy.\n\nExclusion Criteria:\n\n* Patients with of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma not receiving systemic therapy.\n* Inability to collect prospective data, measure response, or perform adequate follow-up assessments in the clinical judgment of the treating physician. NOTE: Repository participation does not exclude participation in clinical trials, nor does existing clinical trial participation exclude enrollment in the study herein outlined.",{"count":54,"type":20},1000,"10 Years","OBSERVATIONAL","The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma. Researchers will use the information from this database to learn more about how to improve outcomes for people with T-cell lymphoma.",[59,60,61,62,63,64,65,66,67,68,69,70,71,30,72,73,74,75,76,77,78,79,80,81,32,26,28,31,82,83,84],"T-cell Lymphoma","NK-Cell Lymphoma","T-cell Prolymphocytic Leukemia","T-cell Large Granular Lymphocytic Leukemia","Chronic Lymphoproliferative Disorder of NK Cells","Aggressive NK-cell Leukemia","Systemic Epstein-Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood (Disorder)","Systemic Epstein Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood","Chronic Active EBV Infection of T-and NK-Cell Type, Systemic Form","Hydroa Vacciniforme-Like Lymphoproliferative Disorder","Adult T-cell Leukemia\u002FLymphoma","Extranodal NK\u002FT-cell Lymphoma, Nasal Type","Enteropathy-associated T-cell Lymphoma","Intestinal T-Cell Lymphoma, Not Otherwise Specified","Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract","Hepatosplenic T-cell Lymphoma","Subcutaneous Panniculitis-Like T-Cell Lymphoma","Mycosis Fungoides","Sezary Syndrome","Primary Cutaneous Anaplastic Large Cell Lymphoma","Primary Cutaneous T-cell Lymphoma","Primary Cutaneous CD8-Positive Aggressive Epidermotropic T-Cell Lymphoma","Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma","Anaplastic Large Cell Lymphoma, ALK-Positive","Anaplastic Large Cell Lymphoma, ALK-negative","Breast Implant-Associated Anaplastic Large Cell Lymphoma",[86,87,88,89,90],"23-190","T-cell lymphoma","Memorial Sloan Kettering Cancer Center","T-cell Lymphoma Master Repository","TCLMR","2026-05-18",{"date":93,"type":37},"2026-05-20",{"date":95,"type":37},"2023-07-27",{"date":97,"type":20},"2030-07-27",{"name":88,"class":44},26,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":133},"100559201","phase-3-soquelitinib-vs-standard-of-care-in-participants-with-relapsedrefractory-peripheral-t-cell-lymphoma-not-otherwise-specified-follicular-helper-t-cell-lymphomas-or-systemic-anaplastic-large-cell-lymphoma-100559201","NCT06561048","Soquelitinib vs Standard of Care in Participants With Relapsed\u002FRefractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma","A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed\u002FRefractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma","Inclusion Criteria:\n\n1. Adult participants ≥18 years of age on the day of signing the informed consent form.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.\n4. Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.\n5. Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist.\n6. Life expectancy \\>12 weeks.\n7. Adequate organ function as determined by:\n\n   * Absolute neutrophil count ≥ 1.0×10\\^9\u002FL (1000\u002Fmm3) (without receiving granulocyte-colony stimulating factor)\n   * Platelet count ≥ 100×10\\^9\u002FL (without transfusion)\n   * Hemoglobin ≥ 9.0 g\u002FdL, without packed red blood cell transfusion within the last 1 week of starting study drug\n   * Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants\n   * Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL\u002Fminute\n   * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg\u002FdL or discussion with the Medical Monitor\n   * Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)\n   * Serum albumin \\> 2.5 g\u002FdL\n   * Serum calcium \\\u003C 12 mg\u002FdL or corrected serum calcium \\\u003C ULN\n8. Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following:\n\n   * Grade ≤ 2 neuropathy\n   * Alopecia and non-acute toxicities\n   * If major received major surgery, then must have recovered adequately per the investigator from the toxicity and\u002For complications from the intervention prior to starting study treatment\n9. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate.\n10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Participants who have T-cell lymphoma with active central nervous system involvement.\n2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.\n3. History of primary immunodeficiency or sold organ transplantation.\n4. History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.\n5. Any active infection requiring IV therapy.\n6. History of invasive prior malignancy that required systemic therapy within last 3 years.\n7. Any condition that confounds the ability to interpret data from the study.\n8. Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \\[HBsAg\\]) or positive test for hepatitis C antibody.\n9. Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment.\n10. Prior administration of an ITK inhibitor.\n11. Participants who need immediate cytoreductive therapy.\n12. Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment.\n13. History of allogeneic hematopoietic stem cell transplantation.\n14. Candidate for hematopoietic stem cell transplantation at screening.\n15. History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.\n16. Concurrent enrollment in another clinical study\n17. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment.\n18. Participants who cannot ingest medications orally or who have malabsorption.",{"count":108,"type":20},150,[110],"PHASE3","A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed\u002Frefractory (R\u002FR) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).",[32,26,28,31,113,114,115],"Systemic Anaplastic Large Cell Lymphoma","Lymphoma, T-Cell, Peripheral","Lymphoma, T-Cell",[117,118,119,120,121,122],"Peripheral T-Cell Lymphoma, Not Otherwise Specified (PTCL-NOS)","Follicular Helper T-Cell Lymphoma (FHTCL)","Angioimmunoblastic T-cell Lymphoma (AITL)","Follicular T-Cell Lymphoma (FTCL)","Nodal Peripheral T-Cell Lymphoma with T Follicular Helper Phenotype (PTCL-Tfh)","Systemic Anaplastic Large Cell Lymphoma (sALCL)","2026-04-02",{"date":125,"type":37},"2026-04-08",{"date":127,"type":37},"2024-10-02",{"date":129,"type":20},"2028-12",{"name":131,"class":132},"Corvus Pharmaceuticals, Inc.","INDUSTRY",34]