[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoma-t-cell-peripheral\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoma-t-cell-peripheral":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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",false,"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.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26,27,28,29,30,31,32],"Peripheral T-Cell Lymphoma, Not Otherwise Specified","Angioimmunoblastic T-cell Lymphoma","Follicular T-Cell Lymphoma","Nodal Peripheral T-Cell Lymphoma With TFH Phenotype","Systemic Anaplastic Large Cell Lymphoma","Lymphoma, T-Cell, Peripheral","Lymphoma, T-Cell",[34,35,36,37,38,39],"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)","RECRUITING","2026-04-02",{"date":43,"type":44},"2026-04-08","ACTUAL",{"date":46,"type":44},"2024-10-02",{"date":48,"type":20},"2028-12",{"name":50,"class":51},"Corvus Pharmaceuticals, Inc.","INDUSTRY",34,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100588942","phase-3-tucidinostat-in-combination-with-chop-in-newly-diagnosed-peripheral-t-cell-lymphoma-with-follicular-helper-of-t-cell-phenotype-100588942","NCT06947967","Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype","A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter Study of Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype (SWIFT 02)","Inclusion Criteria:\n\n1. Provide written informed consent for the study.\n2. Male or female, age ≥ 18 years and ≤80 years.\n3. ECOG PS 0,1 or 2.\n4. Participants with histologically proven peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH), including: a. angioimmunoblastic T-cell lymphoma, b. follicular helper T-cell lymphoma, follicular type, c. follicular helper T-cell lymphoma, NOS.\n5. At least one measurable disease according to the Lugano 2014 Classification.\n6. Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry):\n\n(1)Hematology values:Hemoglobin (Hb)≥90g\u002FL,Absolute neutrophil count (ANC) ≥1.5×10 9\u002FL, platelets ≥90×10 9\u002FL (2)Biochemical values: Serum creatinine ≤1.5×upper limit of normal(ULN),Total bilirubin ≤1.5 × ULN, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤2.5×ULN(ALT, AST≦5×ULN if liver involved).\n\n7.Expected survival≥6 months.\n\nExclusion Criteria:\n\n1. Presence of CNS involvement.\n2. Received prior therapies targeting lymphoma.\n3. Participants planned for autologous or allogeneic transplant as consolidation after CR.\n4. Participants with any other malignancy in past 5 years, except for local tumors that have been cured.\n5. Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis).\n6. Any investigational therapy within 3 months.\n7. Contraindication to any of the individual components of CHOP.\n8. Corticosteroid use \\> 30 mg\u002Fday of prednisone or equivalent, for purposes other than lymphoma symptom control, and the following conditions for inclusion must be met, a. participants receiving corticosteroid treatment with ≤ 30 mg\u002Fday of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to randomization, b. If glucocorticoid treatment is urgently required for lymphoma symptom control prior to the start of study treatment, prednisone 100 mg or equivalent could be given for a maximum of 7 days, but all tumor assessments must be completed prior to start of glucocorticoid treatment.\n9. Ongoing serious central nervous system disease or peripheral neuropathy, such as progressive multifocal leukoencephalopathy.\n10. Have uncontrolled or significant cardiovascular disease, including a. Grade Ⅱ or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (New York Heart Association Functional Classification ) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% during screening stage b.Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al) c.History of significant QT interval prolongation, or Corrected QT Interval QTc≥450ms(male), QTc≥470ms（female）at screening d.Symptomatic coronary heart disease requiring treatment e.Any other cardiovascular disease which is inappropriate for the study according to investigators' judgment.\n11. History of interstitial lung disease(ILD), or with ongoing signs and symptoms by CT or MRI at the time of screening.\n12. Participants with factors that could affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy.\n13. History of deep vein thrombosis or pulmonary embolism.\n14. History of active bleeding within 2 months prior to the start of Cycle 1;or participants receiving anticoagulation therapy; or participants with evidence of bleeding potential according to investigators' judgment ( esophageal varices, active ulcer, or fecal occult blood test positive etc. ). participants with bleeding led by lymphoma according to investigators' judgment are eligible.\n15. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or severe unhealed wounds, ulcers, or fractures were performed within 4 weeks. Tissue biopsy or other minor surgical procedure (other than venipuncture for intravenous fluids) within 7 days.\n16. Active infection requiring systemic treatment (oral, intravenous infusion) was present within 2 weeks prior to the first dose. Participants receiving prophylactic antibiotic therapy (e.g., interstitial pneumonia) may be enrolled.\n17. HBsAg or HBcAb positive with virus replication (except for virus replication positive that non-active hepatitis B assessed by investigators), HCV-Ab positive with virus replication positive, active syphilis infection (positive for syphilitic-specific and non-specific antibodies).\n18. History of HIV infection, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or stem cell transplantation.\n19. Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or limit compliance with study requirements\u002F treatment.\n20. Drug or alcohol abuse.\n21. Women patients of childbearing potential who are unwilling or unable to use an effective method of contraception throughout the treatment period of this trial and for 12 weeks after the last dose of tucidinostat\u002Fplacebo or CHOP, whichever is the latest, or the spouses of male participants.\n22. Any other condition which is inappropriate for the study according to investigators' judgment.","80 Years",{"count":62,"type":20},224,[23],"A Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell Phenotype",[31],"2025-09-09",{"date":68,"type":44},"2025-09-15",{"date":70,"type":44},"2025-08-12",{"date":72,"type":20},"2032-12",{"name":74,"class":51},"Chipscreen Biosciences, Ltd.",1]