[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-cell-lymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,43,72,104,147,203,233,261,291,317,343,369,403,426,453,485,512],{"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":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100349417","phase-1-cd4car-for-cd4-leukemia-and-lymphoma-100349417",false,"NCT03829540","CD4CAR for CD4+ Leukemia and Lymphoma","A Phase I, Multicenter Study of CD4- Directed Chimeric Antigen Receptor Engineered T-cells (CD4CAR) in Patients With Relapsed or Refractory CD4+ Hematological Malignancies","Inclusion Criteria\n\nIn order to be eligible to participate in this study, an individual will be enrolled if they meet the following criteria:\n\n1. Patients must voluntarily sign and date informed consent forms that state his or her willingness to comply with all study procedures and availability for the duration of the study.\n2. Age 12 years old or older\n3. Subjects with any documented CD4+ T cell hematologic malignancies. Male and female subjects with CD4+ T-cell hematologic malignancies with either relapsed or refractory disease (including those patients who have undergone a prior transplant (if allogeneic, subjects are eligible if there are no remaining donor cells) and patients with an inadequate response after 4-6 cycles of standard chemotherapy) are eligible. Response criteria for each disease subset will be evaluated based on Standard of Care Guidelines.\n4. Creatinine clearance of \\> 60 ml\u002Fmin (or otherwise non clinically-significant, per study investigator)\n5. ALT\u002FAST \\\u003C 3 x ULN\n6. Bilirubin \\\u003C 2 x ULN\n7. No supplemental oxygen at rest Note: Pulmonary Function Test (PFT) only required per treating physician discretion\n8. Adequate cardiac function with EF of ≥50%\n9. Adequate venous access for apheresis and no other contraindications for leukapheresis\n\nExclusion Criteria\n\n1. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential (see definition below) must have a negative serum or urine pregnancy test prior to initiation of conditioning chemotherapy, per research sites' clinical policy.\n2. Uncontrolled active infection necessitating systemic therapy.\n3. Active hepatitis B or hepatitis C infection. Active hepatitis C is defined as the hepatitis C antibody is positive while quantitative HCV RNA results exceed the lower detection limit.\n\n   Note the following subjects will be eligible:\n   * Subjects with a history of hepatitis B but have received antiviral therapy and have nondetectable viral DNA for 6 months prior to enrollment are eligible\n   * Subjects seropositive for HBS antibodies due to hepatitis B virus vaccine with no signs or active infection (Negative HBs Ag, HBc and HBe Ags) are eligible\n   * Subjects who had hepatitis C but have received antiviral therapy and show no detectable hepatitis C virus (HCV) viral RNA for 6 months are eligible\n   * If hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative.\n4. Concurrent use of systemic glucocorticoids in greater than replacement doses (unless as a part of a standard of care salvage therapy or conditioning protocol), or steroid dependency defined in rheumatological and pulmonary diseases as uninterrupted corticosteroid intake for more than a year at a dosage of 0.3 mg\u002Fkg\u002Fday or greater, and where the underlying disease worsens on temporary stoppage of steroid therapy, with symptoms of steroids withdrawal (eg, lethargy, headache, weakness, pseudorheumatism, emotional disturbances, etc) precipitated by the temporary stoppage.\n\n   Subjects who receive daily corticosteroids in replacement doses can be included in the study. The replacement doses are defined as following:\n   1. Hydrocortisone 25mg\u002Fday or less\n   2. Prednisone 10mg\u002Fday or less\n   3. Dexamethasone 4mg or less Note: Recent or current use of inhaled glucocorticoids is not exclusionary, as this route pertains extremely minimal systemic penetration.\n5. Any uncontrolled active medical disorder that would preclude participation as outlined in the opinion of the treating investigator and\u002For study chair\n6. HIV infection.\n7. Subjects declining to consent for treatment\n8. Subjects who have received or will receive live vaccines within 30 days before the first experimental cell treatment. Inactivated seasonal flu vaccination is allowed.\n9. Subjects with active autoimmune diseases who need systematic treatments (such as disease modifying agents, corticosteroids and immunosuppressive drugs) in the last 2 years. Note: Replacement therapy (thyroxine, insulin or physiological corticosteroid replacement therapy (up to10 mg of oral daily prednisone or equivalent in hydrocortisone and dexamethasone) to treat adrenal dysfunction or pituitary dysfunction) is not considered as systematic therapy. Subjects who need inhalation corticosteroid therapy can be included in this trial. Subjects with vitiligo or in long-term remission of pediatric asthma or allergic diseases can be included in this trial.\n10. Subjects with a history of mental disorders or drug abuse that may influence treatment compliance.\n11. Active malignancy not related to a T-cell malignancy that has required therapy in the last 3 years or is not in complete remission. Exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy. Other similar malignant conditions may be discussed with and permitted by the Principal Investigator.\n12. Treatment with any investigational cell\u002Fgene therapy within the past 6 months\n13. Treatment with any investigational anticancer agent within 14 days of study entry or 5 half-lives (whichever is shorter)\n\nEligibility for Conditioning Chemotherapy\n\n1. Specific organ function criteria for cardiac, renal, and liver function must be similar to initial inclusion values.\n2. Review of co-morbidities to confirm no major changes in health status (examples of major changes include heart attack, stroke, and any major trauma).\n3. Planned infusion dose was successfully manufactured and met release criteria.\n4. Negative pregnancy testing (if applicable).\n\nEligibility for CD4CAR infusion:\n\nInclusion\n\n1. Afebrile and not receiving antipyretics, and no evidence of active infection.\n2. Specific organ function criteria for cardiac, renal, and liver function must be similar to initial inclusion values. The following test does not need repeated: EF if obtained within 6 weeks of initial assessment.\n3. If previous history of corticosteroid chemotherapy, subject must be off all but adrenal replacement doses 3 days before the CD4CAR infusion.\n\nExclusion\n\nNote: A subject may still receive the CD4CAR infusion up to 10 days post conditioning chemotherapy as long as they do not meet any of the following at time of infusion:\n\n1. Requirement for supplemental oxygen to keep saturation greater than 95% or presence of radiographic abnormalities on a clinically indicated chest x-ray that are progressive.\n2. New cardiac arrhythmia not controlled with medical management.\n3. Hypotension requiring pressor support.\n4. Positive blood cultures for bacteria, fungus, or virus within 48-hours of T cell infusion.\n\nContraception and Reproductive Potential Guidelines Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test prior to conditioning chemotherapy.\n\nDue to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception from time of consent through at least 90 days after CD4CAR infusion.\n\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide\n* Intrauterine device (IUD)\n* Hormonal-based contraception Subjects who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, salpingotomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception. Acceptable documentation of sterilization, azoospermia, and menopause is specified next:\n\nWritten or oral documentation communicated by clinician or clinician's staff of one of the following:\n\n* Physician report\u002Fletter\n* Operative report or other source documentation in the subject record (a laboratory report of azoospermia is required to document successful vasectomy)\n* Discharge summary\n* Laboratory report of azoospermia\n* Follicle stimulating hormone measurement elevated into the menopausal range","ALL","12 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study is designed as a single arm open label Phase I, 3x3, multicenter study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory T-cell leukemia and lymphoma. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells. Funding Source - FDA OOPD",[26,27],"T-cell Lymphoma","T-cell Leukemia",[29],"CD4; T-cell; lymphoma; leukemia; chimeric antigen; CAR-T","RECRUITING","2026-06-22",{"date":33,"type":34},"2026-06-24","ACTUAL",{"date":36,"type":34},"2020-07-09",{"date":38,"type":20},"2042-12",{"name":40,"class":41},"Huda Salman","OTHER",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100641513","a-multi-center-prospective-registry-study-to-analyze-the-clinical-characteristics-and-prognosis-of-different-molecular-subtypes-of-peripheral-t-cell-lymphoma-100641513","NCT07657572","A Multi-center, Prospective, Registry Study to Analyze the Clinical Characteristics and Prognosis of Different Molecular Subtypes of Peripheral T-cell Lymphoma.","Different Molecular Subtypes of Peripheral T-cell Lymphoma, a Real-world Registry Study. (EXCELLENT Study)","EXCELLENT","Inclusion Criteria:\n\n* Patients diagnosed with peripheral T-cell lymphoma (PTCL) by histopathology from June 2026 to December 2029 and detected by gene sequencing (NGS) with different molecular subtypes.\n* Patients diagnosed with PTCL by histopathology from January 2026 to June 2026 and NGS detection can be performed if there is tumor tissue.\n* Fully understand the study, voluntarily sign the written informed consent form (ICF), and agree to cooperate with genetic testing, treatment, efficacy assessment and long-term follow-up.\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Female patients who are pregnant, breastfeeding, or of childbearing potential without effective contraception;\n* Subjects with poorly controlled neurological, psychiatric, mental or cognitive disorders that may impair their understanding and signing of the informed consent form as well as adherence to the study procedures;\n* Any other conditions deemed inappropriate for enrollment by the investigator.","18 Years",{"count":53,"type":20},1000,"OBSERVATIONAL","A multi-center, prospective, registry study to analyze the clinical characteristics and prognosis of different molecular subtypes of peripheral T-cell lymphoma.",[57,58],"PTCL","T Cell Lymphoma",[60,61],"Peripheral T Cell Lymphoma","molecular subtypes","NOT_YET_RECRUITING","2026-06-14",{"date":65,"type":34},"2026-06-18",{"date":67,"type":20},"2026-06",{"date":69,"type":20},"2030-12",{"name":71,"class":41},"Ruijin Hospital",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100463326","phase-2-pembrolizumab-and-brentuximab-vedotin-in-subjects-with-relapsedrefractory-t-cell-lymphoma-100463326","NCT05313243","Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed\u002FRefractory T-cell Lymphoma","Phase 2 Study of Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed\u002FRefractory CD30 Positive T-cell Lymphoma","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of T-cell Non-Hodgkin lymphoma (T-NHL) will be enrolled in this study.\n2. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Histologically confirmed T-cell Non-Hodgkin lymphoma (T-NHL), including:\n\n   * Peripheral T-cell lymphoma not other specified (PTCL nos)\n   * Angioimmunoblastic T-cell lymphoma (AITL)\n   * Anaplastic large-cell lymphoma (ALCL)\n   * Natural killer (NK)\u002FT-cell lymphoma (nodal or extranodal)\n   * Cutaneous T-cell lymphoma (CTCL), including mycosis fungoides (MF)\u002Fsezary syndrome\n   * Transformed T-cell lymphoma\n   * Enteropathy-associated T-cell lymphoma (EATL);\n   * Subcutaneous panniculitis-like T-cell lymphoma (SCPTCL)\n   * Hepatosplenic T- cell lymphomas.\n5. Presence of CD30 (\\>1%) by IHC on a previous biopsy sample\n6. Relapsed\u002Frefractory disease having failed at least one prior systemic therapy Note: Single agent Brentuximab could have been a prior line of therapy EXCEPT those with ≥ grade 2 side effects leading to treatment discontinuation or those refractory to Brentuximab\n7. For patients with peripheral T-cell lymphoma (PTCL): At least one measurable target lesion ≥1.5 cm\n8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   * Not a woman of childbearing potential (WOCBP)\n   * A woman of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test during screening within 72 hours prior to receiving first dose of protocol-indicated treatment, and must agree to follow instructions for using acceptable contraception from the time of signing consent, and at least 120 days (4 months) after her final dose of pembrolizumab.\n9. A male participant must agree to use contraception during the treatment period and for at least at least 120 days (4 months) after the final dose of pembrolizumab. and refrain from donating sperm during this period.\n10. Adequate organ and bone marrow function resulted ≤ 10 days prior to first dose of protocol-indicated treatment:\n\nExclusion Criteria:\n\n1. Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n2. Patients with adult T-cell leukemia\u002F lymphoma (ATLL)\n3. Has received prior systemic anti-cancer therapy including investigational agents ≤ 4 weeks prior to first dose of study treatment on Cycle 1, Day 1. Could consider shorter interval for kinase inhibitors or other short half-life drugs.\n\n   Note: concurrent use of bexarotene or vorinostat (where the dose has been stable for the 8 weeks prior to initiating therapy on trial) is permitted for CTCL. Concurrent use of topical steroids or therapies for CTCL is allowed.\n\n   Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or to baseline value (i.e. condition prior to initiation of the therapy associated with the AE). Participants with ≤Grade 2 neuropathy as AE may be eligible.\n\n   If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n4. Pregnant or breast-feeding females. A WOCBP who has a positive urine pregnancy test at screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 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.\n5. Has received radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n6. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n7. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n\n   Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n9. Has a 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 to the first dose of study drug.\n10. Has active autoimmune disease that has required systemic treatment in the past one year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n    Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n11. Active uncontrolled infection requiring systemic therapy (patients must be afebrile for ≥ 48 hours off antibiotics prior to first protocol treatment). If fever is attributed to tumor fever (B symptom) then this criteria would not apply.\n12. Active myocarditis, regardless of etiology; or New York Heart Association (NYHA) functional classification III-IV heart failure.\n13. 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 treatment.\n14. Disease free of prior malignancies for ≥ 1 year with exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma \"in situ\" of the cervix or breast. (Other malignancies will require advance discussion and agreement between the investigator and the sponsor-investigator regarding risk of recurrence.)\n15. Known severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n16. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.\n17. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n18. Has a history or current evidence of any condition (e.g. renal disease that would preclude treatment or obstructive pulmonary disease and history of bronchospasm), therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n19. Clinically significant history of liver disease, including current alcohol abuse or cirrhosis.\n20. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n21. Has a known history of active TB (Bacillus Tuberculosis).\n22. Prior allogeneic stem cell transplant within last 5 years or active graft vs. host disease (GVHD).\n23. Patients with grade 2 or higher peripheral neuropathy",{"count":80,"type":20},32,[82],"PHASE2","This is a single arm, open label, multicenter study phase 2 study of pembrolizumab and brentuximab in subjects with relapsed\u002Frefractory CD30 positive T-cell lymphoma (including peripheral T-cell lymphoma and cutaneous T-cell lymphoma) who have received at least one prior therapy. We hypothesize that this combination is effective and will produce an overall response rate of \\~55%. Pembrolizumab and brentuximab will be administered for 16 cycles in subjects with responsive disease. Pembrolizumab will be continued for an additional 19 cycles (total 35 cycles). Response assessments will occur at pre-specified intervals. For the primary endpoint the response assessment after 3 cycles will be taken into consideration. Dose adjustments for specific toxicities with either drug are detailed in the protocol. Based on statistical analysis 32 subjects will need to be accrued to evaluate for disease response based on historical control.",[85],"T-Cell Lymphoma",[87,88,89,90,91,92,93],"Relapsed","Refractory","CD30 positive","Peripheral T-cell lymphoma","Cutaneous T-cell lymphoma","Pembrolizumab","Brentuximab","2026-06-09",{"date":96,"type":34},"2026-06-11",{"date":98,"type":34},"2023-07-10",{"date":100,"type":20},"2028-07-30",{"name":102,"class":41},"Yale University",2,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":115,"conditions":116,"keywords":133,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100526212","pharmacokinetic-study-of-venetoclax-tablets-crushed-and-dissolved-into-a-solution-100526212","NCT06131801","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has the 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 with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","0 Years","38 Years",{"count":114,"type":20},30,"The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution",[117,118,119,120,16,121,122,123,124,125,126,127,128,129,130,26,131,60,132],"Hematologic Malignancy","Leukemia","Lymphoma","Acute Lymphocytic Leukemia","Acute Myelogenous Leukemia","AML","Chronic Myelogenous Leukemia","CML","Myeloproliferative Neoplasm","Non Hodgkin Lymphoma","Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Burkitt Lymphoma","B Cell Lymphoma","Cutaneous B-Cell Lymphoma",[134,135,136],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML","2026-06-02",{"date":139,"type":34},"2026-06-04",{"date":141,"type":34},"2023-11-15",{"date":143,"type":20},"2027-12-01",{"name":145,"class":41},"Children's Hospital Medical Center, Cincinnati",5,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":154,"targetDuration":155,"studyType":54,"phases":4,"briefSummary":156,"conditions":157,"keywords":188,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},"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":53,"type":20},"10 Years","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.",[26,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187],"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","Monomorphic Epitheliotropic Intestinal 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","Peripheral T-Cell Lymphoma, Not Otherwise Specified","Angioimmunoblastic T-cell Lymphoma","Follicular T-Cell Lymphoma","Nodal Peripheral T-Cell Lymphoma With TFH Phenotype","Anaplastic Large Cell Lymphoma, ALK-Positive","Anaplastic Large Cell Lymphoma, ALK-negative","Breast Implant-Associated Anaplastic Large Cell Lymphoma",[189,190,191,192,193],"23-190","T-cell lymphoma","Memorial Sloan Kettering Cancer Center","T-cell Lymphoma Master Repository","TCLMR","2026-05-18",{"date":196,"type":34},"2026-05-20",{"date":198,"type":34},"2023-07-27",{"date":200,"type":20},"2030-07-27",{"name":191,"class":41},26,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":210,"maxAge":51,"enrollmentInfo":211,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":214,"conditions":215,"keywords":218,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100546083","phase-2-adding-dasatinib-or-venetoclax-to-improve-responses-in-children-with-newly-diagnosed-t-cell-acute-lymphoblastic-leukemia-all-or-lymphoma-t-lly-or-mixed-phenotype-acute-leukemia-mpal-100546083","NCT06390319","Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)","SJALL23T: Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)","Inclusion Criteria:\n\n* Enrollment on INITIALL.\n* Age 1-18.99 years at the time of enrollment on INITIALL.\n* T-Acute lymphoblastic leukemia or lymphoblastic lymphoma or mixed phenotype acute leukemia\u002F lymphoma\n* No prior chemotherapy excluding therapy given on or allowed by INITIALL.\n* Patient has completed no more than 3 days of chemotherapy on INITIALL.\n* Direct bilirubin ≤ 1.5x the upper limit of normal for age\n* Alanine aminotransferase (ALT) ≤ 5x the upper limit of normal for age\n* Calculated glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73m\\^2 using the Bedside Schwartz equation OR creatinine below or equal to the maximum defined below:\n\n  * Age: 1 to \\\u003C 2 years - Maximum serum creatinine (mg\u002FdL): 0.6 (Male), 0.6 (Female)\n  * Age: 2 to \\\u003C 6 years - Maximum serum creatinine (mg\u002FdL): 0.8 (Male), 0.8 (Female)\n  * Age: 6 to \\\u003C 10 years - Maximum serum creatinine (mg\u002FdL): 1 (Male), 1 (Female)\n  * Age: 10 to \\\u003C 13 years - Maximum serum creatinine (mg\u002FdL): 1.2 (Male), 1.2 (Female)\n  * Age: 13 to \\\u003C 16 years - - Maximum serum creatinine (mg\u002FdL): 1.5 (Male), 1.4 (Female)\n  * Age: ≥ 16 years - Maximum serum creatinine (mg\u002FdL): 1.7 (Male), 1.4 (Female)\n\nExclusion Criteria:\n\n* Inability or unwillingness to give informed consent\u002F assent as applicable.\n* Patients with \\> Grade 2 neuropathy at the time of enrollment (participant with T-LLy only).\n* Documented malabsorption syndrome or any other condition that precludes receipt of oral medications.\n* Known HIV infection or active hepatitis B (defined as hepatitis B surface antigen-positive) or C (defined as hepatitis C antibody-positive).\n* Pregnant or lactating.\n* For patients of reproductive potential, unwillingness to use highly effective contraception for the duration of protocol therapy and for 90 days afterwards.\n* Receipt of a strong or moderate CYP3A4 inducer such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of protocol treatment.\n* Consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days of the start of protocol therapy.","1 Year",{"count":212,"type":20},100,[82],"This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia.\n\nPrimary Objective\n\n* To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231.\n* To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231.\n\nSecondary Objectives\n\n* To assess the event free and overall survival of patients treated with this therapy.\n* To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.",[216,26,217],"T-cell Acute Lymphoblastic Leukemia","Mixed Phenotype Acute Leukemia",[219,220,221,216,26,222],"Newly Diagnosed","Children","Young Adults","Mixed Phenotype Acute Leukemia (MPAL)","2026-04-29",{"date":225,"type":34},"2026-05-01",{"date":227,"type":34},"2024-12-27",{"date":229,"type":20},"2033-12",{"name":231,"class":41},"St. Jude Children's Research Hospital",3,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":242,"conditions":243,"keywords":246,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":260},"100634382","epidemiology-and-management-of-cutaneous-t-cell-lymphoma-at-hospital-mxico-costa-rica-100634382","NCT07538960","Epidemiology and Management of Cutaneous T-Cell Lymphoma at Hospital México, Costa Rica.","Epidemiological Profile and Therapeutic Management of Patients Diagnosed With Cutaneous T-cell Lymphoma Evaluated in the Dermatology Department of Hospital México During the Period From 2019 to 2025.","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of cutaneous T-cell lymphoma, established through clinical, histopathological, and immunohistochemical criteria, documented in EDUS of Hospital México in the Dermatology Service of Hospital México during the period between January 2019 and December 2025.\n* Patients aged 18 years or older, of both sexes.\n* Patients with at least one dermatological evaluation recorded during the study period.\n* Patients who, having a confirmed diagnosis, have received some modality of treatment, including skin-directed therapies (phototherapy, topical treatments, localized radiotherapy) and\u002For systemic treatments.\n\nExclusion Criteria:\n\n* Clinical records that are insufficient or incomplete, preventing adequate diagnostic classification, staging, therapeutic characterization, or evaluation of clinical evolution.\n* Patients with a presumptive diagnosis of cutaneous T-cell lymphoma without histopathological confirmation.\n* Duplicate or inconsistent records that hinder the correct identification and classification of the patient.\n* Patients attended outside the established study period.\n* Patients outside the age range.\n* Patients who do not belong to the Dermatology Service of Hospital México.",{"count":241,"type":20},350,"Adult patients (≥18 years) with confirmed cutaneous T-cell lymphoma evaluated at Hospital México between 2019 and 2025 will be retrospectively analyzed using EDUS records to describe their epidemiological profile, clinical characteristics, treatments, and outcomes.",[244,245,26],"Lymph Node Cancer","Cutaneous",[247,248,85,249],"Linfoma","Cutaneous Lymphoma","Therapy","2026-04-13",{"date":252,"type":34},"2026-04-20",{"date":254,"type":20},"2026-05",{"date":256,"type":20},"2027-05",{"name":258,"class":259},"Caja Costarricense de Seguro Social","OTHER_GOV",1,{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":21,"phases":270,"briefSummary":271,"conditions":272,"keywords":277,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":260},"100620332","phase-2-ruxolitinib-maintenance-post-hematopoietic-stem-cell-transplant-t-cell-lymphoma-100620332","NCT07356245","Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma","Phase II Study of Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant in T-Cell Lymphoma","Inclusion Criteria:\n\n1. Adult patients with T-cell lymphoma \\[PTCL (all subtypes), T-PLL, ATLL, and CTCL (all subtypes)\\] in partial or complete remission between day +35 and +120 from auto-SCT or allo-SCT\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less\n3. Adequate hematologic function defined by absolute neutrophil count (ANC) \\> 1000\u002Fmm3 without granulocyte colony-stimulating factor (G-CSF) for at least 3 days, platelets \\> 50K\u002Fmm3 without transfusion for at least 3 days and hemoglobin (Hb) \\> 8.0 g\u002FdL without transfusion for at least 3 days.\n4. Adequate organ function defined by total Bilirubin \\\u003C 1.5 x ULN, alanine aminotransferase (ALT) \\\u003C\u002F= 3 x ULN, CKD-EPI eGFR ≥ 30 ml\u002Fmin, SpO2 \\> 92% without supplemental oxygen.\n5. Able to tolerate oral or enteral medications.\n6. Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.\n7. Able to read and sign informed consent.\n\nExclusion Criteria:\n\n1. Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (\\\u003C2) in first complete remission.\n2. Progressive disease or any other systemic therapy post-SCT (radiation allowed)\n3. Disease progression to Ruxolitinib previously\n4. GvHD requiring systemic therapy.\n5. Active uncontrolled infections.\n6. Active thrombotic active microangiopathy requiring therapy.\n7. History of veno-occlusive disorder post-transplant\n8. Use of platelets antiaggregant or anticoagulants deemed to be unsafe to be held in case of thrombocytopenia.\n9. History of life-threatening bleeding defined as any bleeding that required invasive procedures or involving central nervous system.\n10. Pregnancy (positive Beta HCG test in a woman with childbearing potential defined as not postmenopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.\n11. Uncontrolled Hepatitis B\u002FC, HIV, tuberculosis, mycobacterium, or fungal infection.\n12. Exposure to other investigational drugs within 4 weeks before enrollment.\n13. Grade ≥ 3 non-hematologic toxicity from SCT that has not resolved to grade ≤ 2.\n14. Myocardial infarction or stroke within 1 year of study entry.\n15. Any uncontrolled medical problem at the discretion of the investigator that would pose a risk to the patient.",{"count":269,"type":20},44,[82],"This phase II trial tests how well ruxolitinib as a maintenance medication works to prevent relapse and graft-versus-host disease (GVHD) for patients who have undergone stem cell transplantation for T-cell lymphoma. GVHD is a common problem that may occur after a blood stem cell transplant. The \"graft\" is the donor blood cells that patients get during the transplant. The \"host\" is the person receiving the cells. GVHD is when the donor graft attacks and damages some of the transplant recipient's tissues. Ruxolitinib is a type of drug called a Janus kinase (JAK) inhibitor which works by decreasing the immune response of cells in the body. It is also a cancer growth blocker that blocks the growth factors that trigger the cancer cells to divide and grow. Ruxolitinib works by blocking a gene, called JAK2, that is important in the production of cancer cells.",[26,273,274,60,159,275,167,276],"Graft Versus Host Disease","Lymphoma, T-Cell","Cutaneous T Cell Lymphoma","Primary Cutaneous T-Cell Non-Hodgkin Lymphoma",[278,279,280,281],"stem cell transplant","graft versus host disease","lymphoma","leukemia","2026-04-10",{"date":284,"type":34},"2026-04-15",{"date":286,"type":34},"2026-02-12",{"date":288,"type":20},"2027-01-31",{"name":290,"class":41},"Jonathan Brammer",{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":21,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":103},"100515798","phase-2-study-of-mogamulizumab-with-da-epoch-or-choep-in-patients-with-aggressive-t-cell-lymphoma-100515798","NCT05996185","Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma","Phase II Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma","Inclusion Criteria:\n\n1. Male\u002Ffemale patients who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of T-cell Non-Hodgkin lymphoma (TNHL) will be enrolled in this study.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 unless compromised by lymphoma with anticipated benefit from chemotherapy as determined and documented by the investigator.\n3. Histologically confirmed T-cell Non-Hodgkin lymphoma (T-NHL), including but not limited to:\n\n   * Peripheral T-cell lymphoma not otherwise specified (PTCL nos)\n   * Angioimmunoblastic T-cell lymphoma (AITL)\n   * Anaplastic large-cell lymphoma (ALCL)\n   * Cutaneous T-cell lymphoma (CTCL), including mycosis fungoides (MF)\u002Fsezary syndrome patients for whom multi-agent chemotherapy is indicated\n   * Transformed mycosis fungoides\u002FSézary syndrome\n   * Enteropathy-associated T-cell lymphoma (EATL)\n   * Subcutaneous panniculitis-like T-cell lymphoma (SCPTCL)\n   * Hepatosplenic T- cell lymphomas\n   * Gamma delta T-cell lymphomas\n   * Adult T-cell lymphoma leukemia (ATLL)\n   * T-prolymphocytic leukemia with nodal or visceral involvement\n4. Prior therapy- patients with aggressive T-cell lymphoma may have received one cycle of CHOP, CHOEP or EPOCH before enrollment, if necessary, to control the disease.\n5. For patients with peripheral T-cell lymphoma (PTCL): At least one measurable target lesion ≥ 1.5 cm\n6. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   * Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR\n   * A woman of childbearing potential (WOCBP) - see Appendix 4 for definition of WOCBP - must have a negative serum or urine pregnancy test during screening and must agree to follow instructions for using acceptable contraception (Appendix 5) from the time of signing consent, and at least 180 days (6 months) after her final dose of mogamulizumab.\n7. A male patient must agree to use a contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least at least 180 days (6 months) after her final dose of mogamulizumab and refrain from donating sperm during this period.\n8. Adequate organ and bone marrow function resulted ≤ 10 days prior to first dose of protocol-indicated treatment unless compromised by disease involvement of bone marrow, spleen, or liver as determined and documented by the investigator.\n9. Patients previously treated with anti-CD4 antibody or alemtuzumab are eligible provided their CD4+ cell counts are ≥ 200\u002Fmm.\n\nExclusion Criteria:\n\n1. Has received prior systemic anti-cancer therapy including investigational agents ≤ 3 weeks prior to first dose of study treatment on Cycle 1, Day 1. Skin directed treatments, including topicals and radiation within 2 weeks of study treatment. However, patients with rapidly progressive malignant disease may be enrolled prior to this period after discussion with the sponsor investigator.\n2. Has received radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n3. If patient received major surgery, participants must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n4. Patients on any immunomodulatory drug for concomitant or intercurrent conditions other than T-cell lymphoma or who have received any of these agents within 4 weeks of treatment, including but not limited to the following, will be excluded: low dose or oral methotrexate; azathioprine; iv immunoglobulin; low dose or oral cyclophosphamide; cyclosporine; mycophenolate; infliximab; etanercept; leflunomide; adalimumab; lenalidomide; abatacept; rituximab; anakinra; interferon-β IL-2 and natalizumab. . Concurrent use of topical steroids or therapies for CTCL is allowed as indicated in the protocol.\n5. Pregnant or breast-feeding females. A WOCBP who has a positive urine pregnancy test within 72 hours of treatment start. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n6. Has received a live vaccine within 30 days prior to the first dose of study drug.\n\n   Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg,FluMist®) are live attenuated vaccines and are not allowed.\n7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n\n   Note: Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n8. Active uncontrolled infection requiring systemic therapy (patients must be afebrile for ≥ 48 hours and off antibiotics prior to treatment). If fever is attributed to tumor fever (B symptom) then these criteria would not apply.\n9. Active myocarditis, regardless of etiology; or New York Heart Association (NYHA) functional classification III-IV heart failure (Appendix 4).\n10. Known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided participants 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 treatment.\n11. Diagnosed with a malignancy, not treated under the study (hormonal therapy for breast or prostate cancer excepted), in the past 2 years. However, patients with nonmelanoma skin cancers, melanoma in situ, localized cancer of the prostate with current prostate-specific antigen of \\\u003C 0.1 ng\u002FmL, treated thyroid cancer or cervical carcinoma in situ or ductal\u002Flobular carcinoma in situ of the breast with in the past 2 years may enroll as long as there is no current evidence of disease.\n12. Known severe hypersensitivity (≥Grade 3) to mogamulizumab and\u002For any of its excipients and \u002For EPOCH\u002For CHOEP or any of its excipients.\n13. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.\n14. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n15. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n16. Has a known history of active TB (Bacillus Tuberculosis).\n17. Prior allogeneic stem cell transplant within last 2 years or active graft vs. host disease (GVHD).\n18. Known active autoimmune disease will be excluded if the disease requires active medical treatment. (For example, Graves' disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).",{"count":299,"type":20},22,[82],"Single-arm Phase II study evaluating the combination of mogamulizumab (MOGA) added on top of standard of care dose adjusted EPOCH (DA-EPOCH) or CHOEP in patients with newly diagnosed or relapsed\u002Frefractory (for CTCL only) aggressive T-cell lymphoma including patients with Adult T-cell leukemia\u002Flymphoma (ATLL).",[58,26],[87,88,304,91,305,306,307,308],"Adult T-Cell Leukemia\u002FLymphoma","Mycosis Fungoides\u002FSézary syndrome","DA-EPOCH","Mogamulizumab","CHOEP","2026-04-09",{"date":311,"type":34},"2026-04-14",{"date":313,"type":34},"2024-10-09",{"date":315,"type":20},"2027-11",{"name":102,"class":41},{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":21,"phases":326,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},"100574209","phase-2-a-study-of-enasidenib-in-people-with-t-cell-lymphoma-100574209","NCT06756308","A Study of Enasidenib in People With T-Cell Lymphoma","A Phase 2 Study of Enasidenib in IDH2-Mutant Angioimmunoblastic T-Cell Lymphoma","Inclusion Criteria:\n\nScreening Cohort (non-MSK patients only)\n\n1. Age ≥18 years at time of consent\n2. Has freely given written informed consent to participate in the study\n\nTreatment Cohort:\n\n1. Pathologically-confirmed AITL at the enrolling institution, with confirmed IDH2 mutation (by MSK ddPCR). For R\u002FR patients, disease must have relapsed or progressed after at least one systemic therapy, diagnostic tumor samples have at least 5% tumor.\n2. Age ≥18 years at time of enrollment\n3. Previous systemic anti-cancer therapy for AITL must have been discontinued at least 2 weeks or 5 half-lives (whichever is longer) prior to treatment.\n\n   i) See section 6.2 Subject Exclusion Criteria for guidelines regarding adjuvant and maintenance therapy for prior malignancy.\n\n   ii) Patients who have received localized RT as part of their immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSKCC Principal Investigator iii) Systemic corticosteroids must be tapered to 25 mg\u002Fday prednisone (or equivalent) upon start of investigational treatment iv) Topical steroids for treating cutaneous involvement of AITL is permitted\n4. Performance status, as assessed in the ECOG grading system, ≤2\n5. Laboratory criteria (use of GCSF and\u002For blood product transfusions to reach eligibility criteria must be discussed with the MSK PI on a case-by-case basis): i) Absolute neutrophil count ≥1.0 K\u002FμL or ≥0.5 K\u002FμL if due to lymphoma ii) Platelet count ≥80 K\u002Fμl or ≥50 K\u002Fμl if due to lymphoma iii) Calculated creatinine clearance ≥30 mL\u002Fmin by the Modification of Diet in Renal Disease (MDRD) glomerular filtration rate iv) Total bilirubin ≤1.5x upper limit of normal (ULN) or ≤3x ULN if documented hepatic involvement with lymphoma, or ≤5x ULN if history of Gilbert's syndrome; AST and ALT ≤ 3x ULN; ≤ 5x ULN if due to lymphoma involvement\n6. Measurable disease, defined by either of:\n\n   * Revised International Working Group Classification for systemic lymphoma(13)\n   * Atypical T lymphocytes quantifiable by flow cytometry or morphology in the peripheral blood or bone marrow\n7. Women of reproductive potential\\* must have a negative serum or urine β human chorionic gonadotropin (β-hCG) pregnancy test. All women of reproductive potential must agree to use adequate methods of birth control throughout the study and for 30 days after the last dose of study drug. \\*A woman of reproductive potential is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n8. Women must agree to not breastfeed during the study period\n9. Male subjects must agree to practice true abstinence from sexual intercourse or to the use of highly effective contraceptive methods with non-pregnant female partners of childbearing potential at screening and throughout the course of the study, and should avoid conception with their partners during the course of the study and for 4 months following the last study treatment\n10. Subject is willing and able to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.\n2. On immunosuppressive therapy post-allogeneic stem cell transplantation at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of a stable dose of oral steroid post-HSCT and\u002For topical steroids for ongoing skin GVHD is permitted after discussion with the study PI\n3. Subject has persistent, clinically significant non-hematologic toxicities grade \\>1 or not to baseline level from prior therapies besides alopecia or neuropathy\n4. Pregnant women\n5. History of chronic liver disease, veno-occlusive disease, or alcohol abuse\n6. Administration of a live vaccine within 6 weeks of first dose of study drug\n7. Prior surgery or gastrointestinal condition that may adversely affect drug absorption (e.g.,gastric bypass surgery, gastrectomy)\n8. Patients with HIV infection with detectable viral load, CD4 count \\\u003C200, or not taking anti-retroviral medications\n9. Patients with chronic hepatitis B or C as defined by positive hepatitis B or C serology:\n\n   1. Subjects with a negative HBsAg and a positive HBcAb require an undetectable\u002Fnegative hepatitis B DNA test (e.g., polymerase chain reaction \\[PCR\\] test) to be enrolled, and will require prophylactic antiviral treatment according to institutional standards of care initiated prior to the first dose of study drug, and continued until approximately 18 months after completion of study drug(s) if rituximab is utilized.\n   2. Patients who are hepatitis C antibody positive with negative PCR may enroll\n10. Subjects with active CMV (defined as positive serum CMV PCR with clinical manifestations consistent with active CMV infection) and requiring therapy. Carriers (low-level positivity by PCR and without evidence of CMV disease) will be monitored per institutional guidelines when such guidelines exist or individual physician practice in the absence of formal guidelines to ensure stability in the PCR level over time and continued absence of CMV disease manifestations.\n11. Receiving therapy for another primary malignancy (other than T-cell lymphoma).\n\n    1. Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.\n    2. Early-stage cutaneous basal cell and squamous cell carcinomas are permissible\n    3. Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy is potentially permissible after discussion with the MSK Principal Investigator.\n12. Known central nervous system or meningeal involvement by AITL (in the absence symptoms, investigation into central nervous system involvement is not required)\n13. Subject has 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)\n14. Subject has significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke; or left ventricular ejection fraction (LVEF) \\\u003C 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 28 days prior to the start of study treatment.\n15. Prior use of enasidenib\n16. Subjects taking the following sensitive CYP substrate medications with narrow therapeutic ranges are excluded from enrolment the study unless they can be safely rotated to other medications within \\>4 half-lives prior to C1D1: warfarin and phenytoin (CYP2C9), S-mephenytoin (CYP2C19), thioridazine (CYP2D6), theophylline and tizanidine (CYP1A2).\n17. Subjects taking the P-gp- and BCRP transporter-sensitive substrates digoxin and rosuvastatin should be counseled with pharmacy input regarding drug-drug interactions.\n\n    1. Digoxin is acceptable with dose modification after consulting with a pharmacist\n    2. Patients taking rosuvastatin should be excluded from the study unless they can safely be rotated to alternative medications within \\>4 half-lives prior to C1D1.\n18. Caution should be exercised on patients on medications that are substrates for UGT1A1 (including but not limited to ezetimibe, raloxifene, and raltegravir). Such patients shall rotate to alternate therapies, or reduce doses of these medications in consultation with the prescribing provider and\u002For a consulting pharmacist. Close monitoring for adverse events shall be pursued in these instances.",{"count":325,"type":20},25,[82],"The researchers are doing this study to find out whether enasidenib is a safe treatment for people with angioimmunoblastic T-cell lymphoma (AITL) that has an IDH2 mutation. The researchers will look at the safety of enasidenib when it is given alone or in combination with the drug rituximab.",[26],[330,331,332,333],"Enasidenib","Rituximab","IDH2-mutant","23-269","2026-04-06",{"date":336,"type":34},"2026-04-07",{"date":338,"type":34},"2024-12-24",{"date":340,"type":20},"2027-12",{"name":191,"class":41},8,{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":21,"phases":352,"briefSummary":353,"conditions":354,"keywords":358,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":325},"100420291","phase-1-bi-1808-as-a-single-agent-and-with-pembrolizumab-keytruda--in-treatment-of-advanced-malignancieskeynote-d20-100420291","NCT04752826","BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)","Phase 1\u002F2a Open-Label, Dose-Escalation, Multicenter, FIH, Consecutive-Cohort, Clinical Trial of BI-1808, a Monoclonal Antibody to TNFR 2 as a Single Agent and in Combination With Pembrolizumab (MK-3475-D20) in Subjects With Advanced Malignancies","Inclusion Criteria:\n\n1. Is willing and able to provide written informed consent for the trial.\n2. Is ≥18 years of age on the day of signing informed consent.\n3. Has a histologically confirmed advanced malignancy. Subjects with CTCL \\[MF or SS\\] who satisfy the Phase 2a, Cohort 3-specific eligibility criteria may be enrolled into the Phase 1 part of the study.\n4. Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.\n5. Has at least 1 measurable disease lesion as defined by RECIST.\n6. Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1808 (on non previously irradiated lesions only). The biopsy must be performed at least 4 weeks following the last dose of tumor directed therapy.\n7. Has a life expectancy of ≥12 weeks.\n8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n9. Has adequate organ function as confirmed by laboratory values.\n\nPhase 2a Expansion Cohort-Specific Inclusion Criteria:\n\nOvarian Cancer:\n\nHistologically confirmed and documented recurrent ovarian, fallopian tube, and peritoneal cancer.\n\nTCL:\n\n1. histologically confirmed diagnosis\n2. Stable doses of systemic steroids (≤20 mg prednisone equivalent) and of low-to-medium potency topical steroids permitted (no change in preceding 4 weeks).\n3. Stage IB-IV with failure of at least 1 systemic therapy.\n4. No current large cell transformation for subjects with CTCL.\n5. Prior therapy - No prior allo hematopoietic stem cell transplantation (HSCT); \\>90 days since auto HSCT; \\>4 weeks since systemic therapy and \\>2 weeks since skin-directed therapy.\n6. Stable doses of systemic steroids (≤20 mg prednisone equivalent) and of low-to-medium potency topical steroids permitted (no change in preceding 4 weeks).\n7. Previous systemic therapies include brentuximab vedotin, bexarotene, extracorporeal photopheresis (ECP), methotrexate, mogamulizumab, romidepsin, vorinostat, or systemic therapy with localized radiation treatment or skin-directed therapy.\n\nMelanoma:\n\n1. Histologically confirmed diagnosis of unresectable or metastatic melanoma.\n\n   Subjects in Part A:\n2. Required prior therapies will include anti-programmed death-ligand 1 (PD-1) therapy either as monotherapy or as part of a combination regimen.\n3. For subjects with a known BRAF V600-activating mutation combination targeted therapy will be required in addition to anti-PD-1\u002Fprogrammed death-ligand 1 (PD-L1) therapy.\n\n   Subjects in part B:\n4. Subjects with prior lines of treatment are not eligible.\n\nAll Tumor Types:\n\nLocally advanced unresectable, recurrent or metastatic immune checkpoint inhibitor-naïve solid tumors, likely to benefit from immune checkpoint inhibitor treatment, based on Investigator opinion.\n\nb. Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.\n\nc. Subjects with known activation mutations must have prior target therapy.\n\nExclusion Criteria:\n\n1. Needs doses of prednisolone \\>10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.\n2. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n3. Has known or suspected hypersensitivity to BI-1808 or pembrolizumab\n4. Has cardiac or renal amyloid light-chain amyloidosis.\n5. Has received the following:\n\n   1. Chemotherapy or small molecule products within 4 weeks of first dose of BI-1808.\n   2. Radiotherapy within 2 weeks of first dose of BI-1808. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) for non-CNS disease. Subjects who have previously had radiation pneumonitis are not allowed.\n   3. Immunotherapy within 4 weeks prior to the first dose of BI-1808.\n6. Has not recovered from AEs to at least Grade 1 by NCI CTCAE\n7. Has had Grade ≥3 autoimmune manifestations of previous immune checkpoint inhibitor treatments (eg, anti-PD-1, anti-PD-L1, or anti-CTLA-4).\n8. Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.\n9. Has an active, known, or suspected autoimmune disease.\n10. Is a female subject and has the ability to become pregnant (or already pregnant or lactating\u002Fbreastfeeding). However, those female subjects who have a negative serum or urine pregnancy test before enrollment and agree to use a highly effective method of birth control for 4 weeks before entering the trial, during the trial, and for 12 months after last dose of BI-1808, are considered eligible.\n11. Is a male subject with partner(s) of childbearing potential (unless he agrees to take measures not to father children by using 1 form of highly effective contraception \\[condom plus spermicide gel\\] during the trial and for 12 months after completing treatment).\n12. Has had major surgery from which the subject has not yet recovered.\n13. Is at high medical risk because of nonmalignant systemic disease including severe active infections on treatment with antibiotics, antifungals, or antivirals.\n14. Has presence of chronic graft versus host disease.\n15. Has had an allogenic tissue\u002Fsolid organ transplant.\n16. Has known human immunodeficiency (HIV) and\u002For history of hepatitis B or C infections, or has a positive test for HIV antibody, hepatitis B antigen\u002Fhepatitis B virus DNA or hepatitis C antibody or RNA.\n17. Has a history of active tuberculosis (Bacillus tuberculosis).\n18. Has received a live vaccine within 30 days before the first dose of study treatment.\n19. Has uncontrolled or significant cardiovascular disease.\n20. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial.\n21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.\n22. Is participating or planning to participate in another interventional clinical trial, or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study drug.\n23. Has a known additional malignancy of another type, with the exception of adequately treated cone biopsied carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) and basal or squamous cell carcinoma of the skin. Male subjects with asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for \\>1 year prior to start of trial therapy are eligible.\n24. Has a diagnosis of primary or acquired immunodeficiency disorder or taking any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.\n25. Has symptomatic ascites or pleural effusion, requires surgical intervention of additional medication",{"count":351,"type":20},176,[23,82],"The goal of this first in human clinical trial is to test BI-1808 administered as single agent and in combination with pembrolizumab in subjects with advanced malignancies whose disease has progressed after standard therapy.\n\nThe main questions it aims to answer are:\n\n* how safe and tolerable is BI-1808\n* what is maximum tolerated or administrated dose\n* to determine recommended dose for further clinical trials. Participants will receive infusions of BI-1808 alone or combination with pembrolizumab every 3 weeks.\n\nFor the purpose of this study, subjects with advanced malignancies includes subjects with advanced solid tumors and subjects with T-cell lymphoma (TCL),",[355,356,26,357],"Advanced Malignancies","Ovarian Cancer","Melanoma",[355,26],"2026-02-16",{"date":361,"type":34},"2026-02-18",{"date":363,"type":34},"2021-01-25",{"date":365,"type":20},"2028-01-15",{"name":367,"class":368},"BioInvent International AB","INDUSTRY",{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":21,"phases":378,"briefSummary":379,"conditions":380,"keywords":387,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":402},"100380473","phase-1-phase-1-trial-of-st-001-nanofenretinide-in-relapsedrefractory-t-cell-non-hodgkin-lymphoma-100380473","NCT04234048","Phase 1 Trial of ST-001 nanoFenretinide in Relapsed\u002FRefractory T-cell Non-Hodgkin Lymphoma","A Phase 1a\u002F1b Trial in Relapsed\u002FRefractory T-cell Non-Hodgkin Lymphoma to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension (12.5 mg\u002FmL) for Intravenous Infusion","Inclusion Criteria:\n\n* All patients must have histologically or cytologically confirmed diagnosis of the following specific types of T-cell lymphomas (TCL):\n\n  1. Cutaneous T-cell lymphoma (CTCL): mycosis fungoides (MF), Sézary Syndrome (SS), or primary cutaneous CD30+ anaplastic large cell lymphoma (cALCL).\n  2. Nodal TCL: Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), or follicular T-cell lymphoma (FTCL) as defined in the 2016 revision of the WHO classification of lymphoid malignancies\\[98\\] (Appendix A).\n* For standard phase 1a and expanded cohort (1b): Patients must all have at least one measurable disease site using criteria provided in section 11.\n* Relapsed or refractory (R\u002FR) disease, after at least 1 prior treatment regimen as per disease staging (including but not limited to oral bexarotene, interferon, any oral or IV HDAC inhibitor, any topical, oral or IV chemotherapy drugs, radiotherapy, retinoids, topical steroids, systemic steroids, phototherapy, immunomodulators, Biologics and others based on PI discretion. Refer to section 2.1 of the protocol for more details).\n* Refractory disease is defined as lack of objective response (i.e., partial or complete response) to most recent therapy.\n* Relapsed disease is defined as recurrent disease after prior therapy that does not qualify as refractory disease.\n* Other systemic treatments not specified may be allowed based on PI judgement in consultation with the Sponsor.\n* For primary cutaneous lymphomas, stage IB, II, III and IV according to the TNMB system (Appendix C) are eligible. For primary nodal lymphomas, patients with stages II-IV according to the Ann Arbor staging system are eligible.\n* Minimum of 4 weeks must have elapsed since last systemic treatment or radiation therapy treatment (or 6 weeks for any nitrosourea-containing regimens), and patients must have recovered from all toxicity of last treatment. If the PI assesses that it is in the best interest of the patient to have a shorter washout period, they may submit a written request to the sponsor and can enroll the patient after written approval has been received.\n* Age ≥18 years. Both genders are included. However, women of childbearing potential must have a negative B-HCG serum pregnancy test (see Section 10 Study Calendar, Pre-Study, footnote b) and agree to use effective contraceptive methods for the duration of the study. A urine pregnancy test is required just prior to the first dosing session of every treatment cycle.\n* ECOG performance status 0-1 (Karnofsky ≥60%, see Appendix B).\n* Life expectancy greater than 6 months.\n* Patients must have normal organ and marrow function as defined below:\n* Leukocytes ≥ 3,000\u002FμL\n* Absolute neutrophil count ≥ 1,500\u002FμL\n* Platelets ≥ 100,000\u002FμL\n* Total bilirubin within normal institutional limits. Patients with total bilirubin ≤ 1.5 X upper limit of normal are eligible\n* AST (SGOT) and ALT (SGPT) within institutional upper limit of normal\n* Creatinine clearance ≥60 mL\u002Fmin\u002F1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation\n\nOr if the patient were to have bone marrow involved NHL, the hematological requirements should be as listed below:\n\n* Absolute neutrophil count ≥ 500\u002FμL\n* Platelets ≥ 50,000\u002FμL\n* Triglyceride blood level (fasting) \\\u003C300mg\u002FdL at time of enrollment (normal: \\\u003C150mg\u002FdL; borderline high = 150-199mg\u002FdL; high = 200-499mg\u002FdL; very high = 500mg\u002FdL or higher).\n* ST-001 is an experimental drug and the risks to the unborn or nursing child are unknown. Pregnant or breastfeeding women cannot take part in this study. Women of childbearing age are required to have a blood and\u002For urine pregnancy test before beginning the investigational study treatment. If you are sexually active, it is important that you not become pregnant or father a child because this medication may be harmful to your unborn child. Patients must discuss pregnancy plans with their doctor before enrolling in this study and agree that they will take the appropriate precautions not to become pregnant while enrolled in the study.\n\nIf there is any chance that patient can get pregnant, patient must either agree to not have vaginal intercourse or you must use two (2) types of birth control (hormonal, barrier method of birth control, abstinence) at the same time. These birth control methods must be used from the time of enrollment, all during investigational study treatment including during temporary breaks from therapy, and for at least 4 months after the last dose of ST-001.\n\n• Informed consent of the patient or a legal authorized representative (LAR) must be obtained prior to any study related procedures.\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Patients who are receiving any other investigational agents.\n* Patients with known or history of central nervous system (CNS) disease are excluded from this clinical trial because of their poor prognosis and because of concerns regarding toxicity attribution.\n* History of allergic reactions or sensitivity to retinoids or to any excipients of ST-001.\n* Concomitant drug administration.\n\nPatients who require concurrent treatment with drugs that are strong CYP3A inducers are excluded from the trial. Patients who have been treated previously with strong CYP3A inducers may enroll in the trial and receive their first dose of ST-001 only after four weeks have elapsed since the last dose of the CYP3A inducer. Strong inducers of human CYP3A include barbiturates, bosentan, carbamazepine, efavirenz, enzalutamide, etravirine, systemic glucocorticoids, mitotane, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, troglitazone as well as the OTC herbal product St John's Wort (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdevelopmentapprovalprocess\u002Fdevelopmentresources\u002Fdruginteractionslabeling\u002Fucm093664.htm#table2-3; http:\u002F\u002Fwww.mayomedicallaboratories.com\u002Fit-mmfiles\u002FCytochrome\\_P450\\_3A4\\_and\\_3A5\\_Known\\_Drug\\_Interaction\\_Chart.pdf; http:\u002F\u002Foncologypro.esmo.org\u002Fcontent\u002Fdownload\u002F66542\u002F1203090\u002Ffile\u002FCYP3A-inhibitors-inducers-DDI.pdf)\n\nPatients who require concurrent treatment with drugs that are strong to moderate CYP3A inhibitors are excluded from the trial, and patients who have been treated previously with strong CYP3A inhibitors may enroll in the trial and receive their first dose of ST-001 only after four weeks have elapsed since the last dose of the CYP3A inhibitor. This group of inhibitors includes certain antivirals (boceprevir, danoprevir, paritaprevir; elvitegravir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir, tipranavir; ombitasvir, dasabuvir), macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin, troleandomycin) and ciprofloxacin, antifungals (e.g., clotrimazole, fluconazole, ketoconazole, itraconazole, nefazodone, posaconazole, voriconazole), aprepitant, cimetidine, cobicistat, conivaptan, crizotinib, cyclosporine, diltiazem, dronedarone, idelalisib, luvoxamine, imatinib, tofisopam, suboxone and verapamil as well as dietary grapefruit juice and grapefruit (https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdevelopmentapprovalprocess\u002Fdevelopmentresources\u002Fdruginteractionslabeling\u002Fucm093664.htm#table2-3; http:\u002F\u002Fwww.mayomedicallaboratories.com\u002Fit-mmfiles\u002FCytochrome\\_P450\\_3A4\\_and\\_3A5\\_Known\\_Drug\\_Interaction\\_Chart.pdf; http:\u002F\u002Foncologypro.esmo.org\u002Fcontent\u002Fdownload\u002F66542\u002F1203090\u002Ffile\u002FCYP3A-inhibitors-inducers-DDI.pdf)\n\nIf patients being treated with ST-001 require the use of drugs that are either strong inducers of CYP3A or strong to moderate inhibitors of CYP3A to treat a medical condition, all treatment with ST-001 should be discontinued immediately and no further treatment with ST-001 will be allowed.\n\nUse of acetaminophen, cephalosporins and other known hepatotoxic agents is allowed with caution and close monitoring, due to known or potential interaction with ST-001 and potential increased risk of hepatotoxicity\\[52\\]. Patients who require replacement therapy with oral steroids should be allowed to continue the treatment if treatment with stable dose has been initiated more than 2 weeks prior to beginning ST-001 infusion. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated list such as http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002F. Medical reference texts such as the Physicians' Desk Reference may also provide this information.\n\nAs part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Physician investigators should consult the websites listed above for the most current information regarding drug interactions via CYP3A isozymes.\n\nUse of vitamin A supplements is prohibited. Standard multivitamin doses are allowed.\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY heart classification III\u002FIV), unstable angina pectoris, cardiac arrhythmia, QTc interval \\>450 milliseconds on baseline triplicate ECG, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because ST-001is a retinoid agent with the 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 with ST-001, breastfeeding should be discontinued if the mother is treated with ST-001.\n* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ST-001. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n* Patients with any active hepatitis infections.\n* Presence of nyctalopia (night blindness), or hemeralopia (defective vision in a bright light, 'day blindness') at enrollment, or any other retinal, ophthalmological condition (eg: retinitis pigmentosa, choroidoretinitis and xerophthalmia), and glaucoma.\n* Patients who have received prior fenretinide systemic therapy\n* Patients with T-cell lymphoma types other than those specified in section 3.1.1 are not eligible even if they have cutaneous dissemination. Similarly, patients with any type of natural killer (NK)- or B-cell lymphoma are not eligible regardless of sites of involvement by disease.",{"count":377,"type":20},46,[23],"This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).",[26,381,382,383,178,384,385,183,182,386,175],"Cutaneous\u002FPeripheral T-Cell Lymphoma","Peripheral T-cell Lymphoma","Peripheral T-Cell Lymphoma, Not Classified","Cutaneous T-Cell Lymphoma, Unspecified","Cutaneous T-cell Lymphoma","Sézary's Disease",[119,388,389,390,57,391,392],"CTCL","Sézary syndrome","mycosis fungoides","AITL","cALCL","2025-09-16",{"date":395,"type":34},"2025-09-22",{"date":397,"type":34},"2023-12-18",{"date":399,"type":20},"2027-05-01",{"name":401,"class":368},"SciTech Development, Inc.",10,{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":16,"minAge":410,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":21,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":424,"locationsCount":260},"100601961","phase-1-cd7-car-t-combined-with-autologous-hematopoietic-stem-cell-transplantation-100601961","NCT07117305","CD7 CAR-T Combined With Autologous Hematopoietic Stem Cell Transplantation","A Clinical Investigation Into the Safety and Efficacy of CD7 Chimeric Antigen Receptor T-cell (CAR-T) Therapy in Combination With Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Relapsed\u002FRefractory T-cell Lymphoma","Inclusion Criteria:\n\n1. With the patient's explicit consent and after signing the informed consent form, the patient is willing and capable of complying with the planned visits, research treatments, laboratory tests and other trial procedures;\n2. Age range: 14 to 65 years old. Both men and women are eligible;\n3. All types of CD7+ T-cell non-Hodgkin's lymphomas (except T-lymphoblastic lymphoma) diagnosed according to the World Health Organization's classification of hematopoietic and lymphoid tissue tumors (2022);\n4. For patients with T-cell lymphoma who are refractory to the first-line chemotherapy regimen or who experience recurrence and resistance after at least the second-line chemotherapy regimen. The following criteria must be met: a. For those patients who had only received first-line treatment previously, if they did not achieve PR after at least 4 cycles of the first-line regimen, or if they did not achieve CR after at least 6 cycles of the first-line regimen; b. Those who experienced recurrence in the early stage (\\\u003C 12 months) after complete remission; or those who experienced recurrence in the late stage (≥ 12 months) and did not achieve remission after one course of standard induction chemotherapy; c. Those who have not achieved remission after treatment with second-line or more chemotherapy regimens;\n5. During the enrollment screening process, the subjects were confirmed to have CD7+ (with CD7 expression ≥ 10%) through pathological histology and\u002For cytology;\n6. Having measurable or evaluable lesions: The target lesion is defined as a lesion within lymph nodes with a long diameter of ≥ 15mm, or an extranodal lesion larger than 10mm (in accordance with the Lugano 2014 criteria); Lesions that have received prior radiotherapy are considered measurable only if there is a clear progression after completing radiotherapy; or PET-positive lesions determined according to the Lugano criteria;\n7. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 to 2, and the estimated survival period is greater than 3 months;\n8. Having appropriate organ functions: a. The levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be ≤ 3 times the upper limit of normal (ULN). If the abnormality of ALT and AST is judged to be caused by the disease (such as liver infiltration or bile duct obstruction), the thresholds can be relaxed to ≤ 5 times ULN; b. Total serum bilirubin ≤ 2 times ULN, except in cases where Gilbert syndrome is present; patients with Gilbert syndrome whose total bilirubin is ≤ 3 times ULN and direct bilirubin is ≤ 1.5 times ULN can be included; c. Serum creatinine ≤ 1.5 times the upper limit of normal, or creatinine clearance rate ≥ 60 mL\u002Fmin; d. The international normalized ratio (INR) is no more than 1.5 times the upper limit of normal (ULN), and the activated partial thromboplastin time (aPTT) is no more than 1.5 times the ULN; e. Having the lowest level of lung reserve, defined as ≤ grade 1 dyspnea (CTCAE v5.0) and a blood oxygen saturation of ≥ 92% in the absence of oxygen supplementation; f. Left ventricular ejection fraction in echocardiography is ≥ 50%; no clinically significant abnormal electrocardiogram findings; no clinically significant pericardial effusion or pleural effusion.\n9. Female participants of childbearing potential must have negative blood\u002Furine pregnancy tests within 7 days prior to infusion. All sexually active males and females with reproductive capacity must agree to use highly effective contraception throughout the study and for at least 2 years after administration of the investigational treatment.\n\nExclusion Criteria:\n\n1. Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) \\\u003C50%；\n2. Documented history of severe pulmonary impairment；\n3. History of organ transplantation or active graft-versus-host disease (GVHD);\n4. Concurrent other progressive malignancies;\n5. Uncontrolled severe infections;\n6. Severe autoimmune diseases or primary immunodeficiency disorders;\n7. Positive for any of the following: Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg); Hepatitis B e antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab) with HBV-DNA levels above the upper limit of normal (ULN); Hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA; Human immunodeficiency virus antibody (HIV-Ab); Treponema pallidum antibody (TP-Ab); Cytomegalovirus (CMV) DNA above ULN; Epstein-Barr virus (EBV) DNA above ULN；\n8. History of severe hypersensitivity to biological products (including antibiotics);\n9. Pre-existing central nervous system disorders, including but not limited to:\n\n   Uncontrolled epilepsy；Cerebral ischemia\u002Fhemorrhage；Dementia；Cerebellar disorders；\n10. Previous recipients of autologous or allogeneic hematopoietic stem cell transplantation;\n11. Any other severe physical or psychiatric conditions or significant laboratory abnormalities that may: Increase study participation risks；Interfere with study results interpretation; Be deemed by investigators to render the patient unsuitable for study participation;\n12. Presence of lymphoma-related clinical emergencies requiring immediate intervention at screening due to tumor mass obstruction or compression (e.g., intestinal obstruction, vascular compression, etc.).","14 Years","65 Years",{"count":413,"type":20},38,[23,82],"This is a single-arm, open-label, phase I\u002FII clinical trial initiated by investigators to evaluate the safety, tolerability, and preliminary efficacy of CD7-targeted chimeric antigen receptor T cells (CD7 CAR-T) combined with autologous stem cell transplantation (ASCT) in patients with relapsed or refractory CD7-positive T-cell lymphomas. Phase I adopts a standard 3+3 dose-escalation design to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Phase II expands at the RP2D to further assess efficacy. The study includes lymphodepletion chemotherapy, ASCT, and sequential infusion of CD7 CAR-T cells. The primary objectives include: (1) Evaluate safety\u002Ftolerability of CD7 CAR-T + auto-HSCT in relapsed or refractory CD7-positive T-cell lymphomas. (2) Determine MTD and RP2D. The secondary objectives include: (1) Assess efficacy (overall response rate, complete response, duration of response, progression-free survival and overall survival. (2)Characterize PK\u002FPD profiles. (3)Investigate anti-tumor mechanisms.",[417,58],"CD7+ Lymphoma","2025-08-04",{"date":420,"type":34},"2025-08-12",{"date":422,"type":20},"2025-09-01",{"date":143,"type":20},{"name":425,"class":41},"Zhengzhou University",{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":433,"targetDuration":435,"studyType":54,"phases":4,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":260},"100558385","early-assessment-of-lymphoma-treatment-response-using-phased-variant-analysis-with-next-generation-sequencing-100558385","NCT06550427","Early Assessment of Lymphoma Treatment Response Using Phased Variant Analysis With Next-Generation Sequencing","Early Assessment of Aggressive B-Cell Lymphoma Treatment Response and Prediction of Recurrence Using Phased Variant Analysis With Next-Generation Sequencing","Inclusion Criteria:\n\n* • Pathology proven lymphoma\n\n  * Age ≥ 18 years old\n\nExclusion Criteria:\n\n* none",{"count":434,"type":20},200,"2 Years","Lymphoma is a prevalent lymphoid malignancy globally and in Taiwan. Large B-cell lymphoma (LBCL) is the most common subtype of aggressive B-cell lymphoma. LBCL's aggressive nature manifests through extranodal involvement, severe symptoms, and relative refractoriness to therapies, leading to a 5-year overall survival rate of 60-70% across developed countries and poorer outcomes in high-risk patients with primary refractory disease. Chemoimmunotherapy remains the primary treatment for LBCL, requiring comprehensive assessment through clinical and imaging examinations, biomarkers, and molecular testing. Currently, computed tomography (CT) and positron emission tomography (PET) scans are the standard modalities for treatment response evaluation, though their radioactive nature calls for the development of safer alternatives. Circulating tumor DNA (ctDNA) analysis has emerged as a promising field, providing insights into tumor molecular characteristics, clinical status, and treatment response by analyzing DNA fragments released from tumor cells into the bloodstream. Dynamic monitoring of ctDNA during treatment can effectively gauge therapeutic efficacy-decreasing ctDNA concentrations suggest successful treatment, while increasing levels may indicate treatment failure or tumor recurrence. The detection of ctDNA has been much improved through advances in next-generation sequencing (NGS) technologies, particularly taking advantage of analyzing phased variants, consecutive gene mutations on the same chromosome, enhances the sensitivity and specificity.",[119,127,26,438],"Waldenstrom Macroglobulinaemia",[119,440,441,442,443],"NGS","Phased Variant","Early Response Assessment","Early Outcome","2025-06-15",{"date":446,"type":34},"2025-06-17",{"date":448,"type":34},"2024-08-09",{"date":450,"type":20},"2027-07-31",{"name":452,"class":41},"National Taiwan University Hospital",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":16,"minAge":435,"maxAge":461,"enrollmentInfo":462,"targetDuration":4,"studyType":21,"phases":464,"briefSummary":465,"conditions":466,"keywords":471,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":260},"100548367","phase-1-sequential-car-t-cells-therapy-for-cd5cd7-positive-t-cell-acute-lymphoblastic-leukemia-and-lymphoblastic-lymphoma-using-cd5cd7-specific-car-t-cells-100548367","NCT06420076","Sequential CAR-T Cells Therapy for CD5\u002FCD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5\u002FCD7-Specific CAR-T Cells","This is an Open, Single-arm, Clinical Study to Evaluate the Efficacy and Safety of Anti-CD7\u002FCD5 CAR-T Cells in the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL), ETP-ALL, and Lymphoblastic Lymphoma (TLBL).","BAH246","Inclusion Criteria:\n\n* Signed written informed consent; Patients volunteer to participate in the clinical trial;\n* Diagnosis is mainly based on the World Health Organization (WHO) 2008;\n* Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%;\n* Leukemic blast cells express CD7\u002FCD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%);\n* The expected survival period is greater than 12 weeks;\n* ECOG score ≤2;\n* Age 2-60 years old;\n* HGB≥70g\u002FL (can be transfused);\n* Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value.\n\nExclusion Criteria:\n\n* Patients declining to consent for treatment\n* Prior solid organ transplantation\n* One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV;\n* History of severe pulmonary dysfunction diseases;\n* Severe infection or persistent infection cannot be effectively controlled;\n* Severe autoimmune disease or congenital immunodeficiency;\n* Active hepatitis;\n* Human immunodeficiency virus (HIV) infection;\n* Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus).","90 Years",{"count":463,"type":20},60,[23,82],"Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5\u002FCD7 in patients with patients with relapsed or refractory T-ALL\u002FLBL\u002FETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.",[58,467,216,468,469,470],"T Cell Leukemia","T-Cell Lymphoma of CNS","T Cell Prolymphocytic Leukemia","T Cell Childhood ALL",[472,473,474,475],"CAR-T","CD5","CD7","ETP-ALL","2024-11-10",{"date":478,"type":34},"2024-11-12",{"date":480,"type":34},"2024-07-10",{"date":482,"type":20},"2026-12-28",{"name":484,"class":41},"Essen Biotech",{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":21,"phases":495,"briefSummary":497,"conditions":498,"keywords":499,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":260},"100533302","early-phase-1-treatment-of-relapsed-or-refractory-epstein-barr-virus-positive-t-cell-lymphoma-with-hneo-t-100533302","NCT06224049","Treatment of Relapsed or Refractory Epstein-Barr Virus Positive T-cell Lymphoma With hNeo-T","A Clinical Study to Evaluate the Safety, Tolerability and Initial Efficacy of Targeted Haploidentical Neoantigen T Cell Injection (hNeo-T) in the Treatment of Relapsed or Refractory EBV-positive T-cell Lymphoma","GI-hNeoT-01","Inclusion Criteria:\n\n1. Age ≥18 years old, and ≤75 years old, gender is not limited;\n2. Must have histologically or cytologically confirmed T-cell lymphoma with at least one measurable tumor lesion (according to Lugano2014 criteria);\n3. The subject's HLA type is HLA-A0201\u002F1101\u002F2402\u002F0203 (containing at least one of the subtypes, as determined by the test report issued by the central laboratory), and there is at least one healthy donor who is a semi-matching HLA type or more with the subject. At least one of the HLA matching loci is HLA-A0201\u002F1101\u002F2402\u002F0203；\n4. The subject has been previously determined to be EBV positive or has been determined to be EBV positive after testing;\n5. The subject has paraffin-embedded tumor tissue\u002Fsection or biopsy tumor tissue within 2.5 years (tissue biopsy is recommended for subjects with easy-to-sample tumor lesions and consent to biopsy), and these tissues are qualified by gene sequencing data. And the tumor neoantigen screening qualified;\n6. Disease progression after adequate first-line systemic treatment, or disease progression ≥2 cycles (PD) after first-line or above systemic systemic treatment, or ≥4 cycles without remission (CR or PR). Remarks: The first-line systemic treatment should refer to the latest version of the \"Lymphoma Diagnosis and Treatment Guide\" issued by China's \"Chinese Society of Clinical Oncology\".\n7. Volunteer to participate in clinical studies; I or legal guardian fully understand and know the study and sign the informed consent; Willing to follow and be able to complete all test procedures;\n8. ECOG score ≤1 score;\n9. Have venous access to meet venous blood collection;\n10. The survival time is expected to be ≥6 months;\n11. The subjects are willing to use a reliable method of contraception during treatment and within 3 months after the end of treatment, and the blood pregnancy test of women of childbearing age is negative;\n12. Laboratory test results and vital organ functions meet the following requirements: 1) \\*HIV antibody negative; No active syphilis infection; Negative antibodies to hepatitis C virus; HBV DNA detection value is lower than the upper limit of normal value; 2) Blood routine: absolute value of neutrophil (ANC) ≥1×10\\^9\u002FL, platelet count (PLT) ≥75×10\\^9\u002FL, hemoglobin concentration (HGB) ≥80g\u002FL; 3) Blood biochemistry: glutamic-pyruvic transaminase (ALT) and glutamic-oxalic transaminase (AST) ≤3 times the upper limit of normal (ULN) (ALT and AST≤5 times ULN in liver metastasis subjects); Serum creatinine ≤1.5 ULN; Total bilirubin ≤1.5 ULN, or total bilirubin \\\u003C3 ULN for subjects with GilbertsSyndrome; 4) Coagulation function: prothrombin time (PT) and International standard ratio (INR) ≤1.5 times ULN, activated partial thromboplastin time (APTT) ≤1.5 times ULN (for subjects taking anticoagulant drugs for a long time, the coagulation related indexes can meet the normal value range after medication); 5) Left ventricular ejection fraction (LVEF) ≥50%;\n13. Before administration with Chemotherapy preconditioning: 1) Any chemotherapy, targeted drugs, immune checkpoint inhibitors, other drugs studied in clinical trials, Chinese medicines with anti-tumor indications, and other anti-tumor treatments received have passed the 4-week washout period, and the toxic side effects have returned to grade 1 or lower (excluding hair loss, vitiligo, and other events that the investigator has judged to be tolerated); 2) If major surgery is performed within 3 weeks, adverse reactions have recovered to grade 1 or lower.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. People with a history of severe hypersensitivity to the cells used in this study and to any drugs;\n3. Patients with a history of organ transplantation, excluding hematopoietic stem cell transplantation;\n4. History of allogeneic hematopoietic stem cell transplantation; Acute or chronic graft-versus-host disease (GVHD);\n5. Clear central nervous system involvement of lymphoma, including parenchyma, meningeal invasion or spinal cord compression;\n6. Any person with active autoimmune disease or who has a history of autoimmune disease that the investigator has determined to be ineligible for this study, including but not limited to the following diseases: Such as systemic lupus erythematosus, immune-related neuropathy, multiple sclerosis, Guillain-Barre syndrome, myasthenia gravis, connective tissue diseases, inflammatory bowel diseases including Crohn's disease and ulcerative colitis (except for patients with vitiligo, eczema, type I diabetes, rheumatoid arthritis and other joint diseases, sjogren's syndrome and psoriasis controlled with topical drugs);\n7. Uncontrolled concomitant or infectious diseases, such as acutely active infected persons requiring systemic antibiotic, antiviral or antifungal treatment within 2 weeks prior to enrollment;\n8. Severe impairment of liver or kidney function (liver or kidney therapy but not controllable, biochemical indicators are not yet able to meet the criteria for inclusion in Article 11), or uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or medically poorly controlled hypertension (systolic blood pressure \\>160mmHg and\u002For diastolic blood pressure \\>90mmHg), Or cardiovascular and cerebrovascular diseases of clinical significance (e.g. active), For example, cerebrovascular accident (within 6 months before the signing of the informed consent), myocardial infarction (within 6 months before the signing of the informed consent), unstable angina, congestive heart failure classified by the New York Heart Association (NYHA) as class II or above, severe arrhythmia that cannot be controlled with drugs, and electrocardiogram results showing clinical significance in 3 consecutive times (each interval of at least 5 minutes) The presence of abnormalities determined by the investigator to affect subsequent cell therapy, or mental illness and substance abuse, or any condition that the investigator believes may increase the risk of the subject or interfere with the test results;\n9. Subjects who were scheduled to receive glucocorticoids (prednisone or equivalent dose \\>10mg\u002F day) or other immunosuppressants for a condition within 2 weeks prior to lymphocyte clearance preconditioning administration and during the study period were excluded. Remarks: In the absence of active autoimmune disease, prednisone or an equivalent adrenal drug dose ≤10mg\u002F day is allowed to substitute administration; Subjects were allowed to use topical, ocular, intraarticular, intranasal, and inhaled corticosteroids (with very low systemic absorption);\n10. Subject is scheduled to receive immunomodulatory drugs (such as interferon, GM-CSF, thymosin, gamma globulin, etc.) within 2 weeks before lymphocyte clearance preconditioning administration and during the study period due to certain conditions;\n11. The investigator evaluates that the subject is unable or unwilling to comply with the requirements of the study protocol;\n12. Those with functional defects of genes related to antigen presentation, antigen recognition and cell killing detected by sequencing;\n13. History of other malignant tumors within the past 5 years; Excluding curable basal or squamous cell skin cancer, superficial bladder or prostate carcinoma in situ, cervical carcinoma in situ or breast carcinoma in situ;\n14. The subject has any disease or medical condition that may affect the evaluation of the safety or efficacy of the investigational drug.","75 Years",{"count":42,"type":20},[496],"EARLY_PHASE1","Objective: To evaluate the safety and tolerability of hNeo-T injection in patients with relapsed or refractory EBV-positive T-cell lymphoma.\n\nSecondary objective: To evaluate the effectiveness of hNeo-T injection, and to evaluate the objective response rate (ORR) and disease control rate (DCR) by Lugano2014 criteria; Progression-free survival (PFS), duration of response (DOR), and overall survival (OS ) followed.\n\nObjective of the exploratory study: To investigate the in vivo process of hNeo-T injection and describe the activity and related biological functions of hNeo-T cells in vivo, including but not limited to.",[26],[500,501,502],"T-cell lymphomas","Epstein-Barr Virus","hNeo-T","2024-03-07",{"date":505,"type":34},"2024-03-12",{"date":507,"type":34},"2023-12-01",{"date":509,"type":20},"2026-06-30",{"name":511,"class":41},"BGI, China",{"id":513,"slug":514,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":11,"sex":16,"minAge":519,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":21,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":260},"100456983","phase-1-azacitidine-chop-for-patients-with-nodal-t-cell-lymphoma-with-t-follicular-helper-phenotype-acantus-100456983","NCT05230680","Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype (ACANTUS)","Multicenter, Open Label, Phase I\u002FII of Azacitidine-CHOP for Patients With Nodal T-cell Lymphoma With T-follicular Helper Phenotype","Inclusion Criteria:\n\n1. Treatment-naïve patients with newly diagnosed nodal T-cell lymphoma with T-follicular helper (TFH) phenotype as determined by the following 2016 WHO diagnostic criteria:\n\n   * Angioimmunoblastic T-cell lymphoma\n   * Follicular helper T-cell lymphoma\n   * Peripheral T-cell lymphoma with follicular helper T-cell type\n2. 20 to 85 years of age at diagnosis\n3. ECOG performance status 0-2\n4. Cardiac function suitable for chemotherapy: LVEF ≥45% on echocardiography or MUGA\n5. Appropriate renal function: Serum Cr ≤2.0mg\u002FdL or eGFR ≥ 30mL\u002Fmin according to the Cockroft-Gault formula\n6. Appropriate hepatic function: ALT ≤2.5x upper limit of normal (ULN) (or ≤5x ULN in the presence of liver involvement), total bilirubin ≤2x ULN (or ≤3x ULN in the presence of liver involvement)\n7. Appropriate hematologic findings: absolute neutrophil count (ANC) ≥1,500\u002FμL, platelets ≥100,000\u002FμL (or ANC ≥500\u002FμL and platelets ≥50,000\u002F μL in the presence of bone marrow involvement)\n8. Written informed consent to participate in the study\n9. Capable of following the study visit schedule and other requirements in the protocol\n10. For women of childbearing potential, a negative pregnancy test\n11. Women of childbearing potential must use an effective method of contraception (i.e., hormonal contraception, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study period and for 3 months afterward. Men are to use an effective method of contraception during the study period and for 3 months afterward.\n12. Life expectancy ≥90 days (3 months)\n13. Hepatitis B or C infection: Hepatitis B carriers and subjects with inactive hepatitis C infection (normal levels of aminotransferases) are eligible if they take prophylactic antiviral drugs\n\nExclusion Criteria:\n\n1. Other subtypes of non-Hodgkin's lymphoma\n2. History of chemotherapy for Hodgkin's or other non-Hodgkin's lymphoma in the last 5 years\n3. History of active cancer diagnosed within the last 3 years (with the exception of completely resected non-melanoma skin cancer, papillary thyroid cancer, carcinoma in situ of cervical cancer or breast cancer, and localized prostate cancer)\n4. Uncontrolled hepatitis B (with the exception of asymptomatic HBsAg-positive or anti-HBcAb-positive cases receiving antiviral prophylaxis such as entecavir or tenofovir)\n5. History of chronic hepatitis C (with the exception of HCV IgG positive with a negative HCV-RNA quantification)\n6. History of human immunodeficiency virus (HIV) infection\n7. Congestive heart failure (NYHA class ≥3)\n8. Acute coronary syndrome (new-onset unstable angina or myocardial infarction) or ventricular tachycardia within 6 months prior to study entry\n9. History of major neurological or psychiatric illness, including dementia or epilepsy\n10. Severe chronic obstructive pulmonary disease with hypoxemia\n11. Cerebrovascular disease within 3 months prior to study entry (including transient cerebral ischemia)\n12. Unresolved wounds, ulcers, or bone fractures\n13. Uncontrolled active infections (viral, bacterial, or fungal infections)\n14. Concurrent use of other experimental drugs under investigation\n15. Known hypersensitivity to the investigational drugs\n16. History of major surgery or serious trauma within 21 days prior to study treatment. Open biopsy within 7 days prior to study treatment\n17. Male subjects who had not undergone a vasectomy and have a partner who plans to become pregnant or are unable to use a medically acceptable method of contraception (partner's sterilization or intrauterine device placement, or barrier method combined with diaphragm or condom) during the subject's participation in the study\n18. Pregnant or breastfeeding women or women of childbearing potential and men who are not willing to use appropriate methods of contraception during the study\n19. Previously treated for T-cell lymphoma with immunotherapy or chemotherapy, except for short-term corticosteroids (for less than 8 days) prior to selection\n20. Prior radiotherapy, except for those localized to a single lymph node\n21. Central nervous system involvement\n22. Contraindication to any of the drugs included in the chemotherapy\n23. History of administration of doxorubicin at \\>200 mg\u002Fm²","20 Years","85 Years",{"count":522,"type":20},41,[23,82],"Induction treatment (every 3 weeks, total 6 cycles)\n\n* Azacitidine D-2, -1, 1 (level 1: 50mg\u002Fm2, level 2: 75mg\u002Fm2, level 3: 100mg\u002Fm2, level 4: 125mg\u002Fm2)\n* Cyclophosphamide 750mg\u002Fm2 d1\n* Doxorubicin 50 mg\u002Fm2 d1\n* Vincristine 1.4 mg\u002Fm2 (Max: 2 mg) d1\n* Prednisolone 100mg PO d1-5 Maintenance treatment (every 4 weeks, total 12 cycles)\n* Azacitidine 75mg\u002Fm2 d1-5",[58],"2023-10-19",{"date":528,"type":34},"2023-10-23",{"date":530,"type":34},"2022-07-01",{"date":532,"type":20},"2026-12-31",{"name":534,"class":41},"Won Seog Kim"]