[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-cell-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-cell-leukemia":116},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,69,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100394053","observatory-of-prolymphocytic-leukemia-t-100394053",false,"NCT04411043","Observatory of Prolymphocytic Leukemia T","Prospective and Retrospective Study Evaluating Epidemiological, Clinical, Molecular and Therapeutic Data of Prolymphocytic Leukemia T. A FILO Study.","T-PLL","Inclusion Criteria:\n\n* Man or woman aged 18 or over\n* Patient with prolymphocytic T leukemia\n\nExclusion Criteria:\n\n* Absence of signature of informed consent","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","3 Years","OBSERVATIONAL","Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an aggressive clinical course. It is a hemopathy exhibiting a post thymic T phenotype (Tdt-, CD1a-, CD5 +, CD2 + and CD7 +), generally CD4 + \u002F CD8-, but also CD4 + \u002F CD8 + or CD8 + \u002F CD4-.\n\nThe main feature of T-PLL is the rearrangement of chromosome 14 involving genes encoding the T cell receptor complex (TCR) subunits, leading to overexpression of the proto-oncogene TCL1.\n\nOn the molecular level, the study of Prolymphocytic leukemia T shows a substantial mutational activation of the IL2RG-JAK1-JAK3-STAT5B axis.\n\nPatients with Prolymphocytic leukemia T have a poor prognosis, due to a poor response to conventional chemotherapy. Treatment with the anti-CD52 monoclonal antibody: alemtuzumab has considerably improved the results, but the responses to treatment are transient; therefore, patients who obtain a response to alemtuzumab treatment are candidates for stem cell allograft (TSS) if they are eligible for this procedure. This combined approach extended the median survival to four years or more. However, new approaches using well-tolerated therapies that target signaling and survival pathways are necessary for most patients who are unable to receive intensive chemotherapy, such as JAK STAT axis inhibitors, anti-AKT, or anti BCL2 .\n\nMain objective: Better manage prolymphocytic T leukemias.\n\nSecondary objectives:\n\n* Molecular characterization of prolymphocytic leukemia T.\n* Study of the response to treatment, disease-free survival, overall survival.\n* Impact of prognostic factors on response to treatment, and survival.",[26,27],"Prolymphocytic Leukemia","T-cell Leukemia","RECRUITING","2026-06-29",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":32},"2020-07-01",{"date":36,"type":21},"2028-07-30",{"name":38,"class":39},"French Innovative Leukemia Organisation","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100349417","phase-1-cd4car-for-cd4-leukemia-and-lymphoma-100349417","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","12 Years",{"count":50,"type":21},20,"INTERVENTIONAL",[53],"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",[56,27],"T-cell Lymphoma",[58],"CD4; T-cell; lymphoma; leukemia; chimeric antigen; CAR-T","2026-06-22",{"date":61,"type":32},"2026-06-24",{"date":63,"type":32},"2020-07-09",{"date":65,"type":21},"2042-12",{"name":67,"class":39},"Huda Salman",6,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":51,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100569727","phase-2-a-study-of-mogamulizumab-to-prevent-adult-t-cell-leukemialymphoma-in-people-with-htlv-1-100569727","NCT06698003","A Study of Mogamulizumab to Prevent Adult T-cell Leukemia\u002FLymphoma in People With HTLV-1","A Phase 2 Study for Screening and Prevention of Adult T-cell Leukemia\u002FLymphoma With Mogamulizumab in High-Risk Carriers of HTLV-1","Inclusion Criteria:\n\nScreening Cohort (US patients only):\n\n* Age ≥18 years when informed consent is obtained\n* Has freely given written informed consent to participate in the study\n\nTreatment Cohorts (Cohorts 1 and 2):\n\n* Positive for anti-HTLV-1 antibody in the serum using an FDA approved assay for US patients (Avioq HTLV-I\u002FII Microelisa System). UK patients should use UK Accreditation Service (UKAS) accredited tests, Abbot Architect ELISA Serology Screening assay and confirmatory serology Western Blot (performed at Public Health England, Virus Ref Dept, Colindale).\n* High-risk phenotype (PVL≥8% of PBMC)\n* Age ≥18 years when informed consent is obtained\n* Primary organ functions are stable\n\n  * Neutrophil count: ≥ 1000\u002Fmm3, unless patient has diagnosis of ethnic neutropenia\n  * Platelets: ≥100,000\u002Fmm3\n  * Hemoglobin: ≥9.0 g\u002FdL\n  * Serum aspartate aminotransferase (AST): ≤1.5x upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT): ≤1.5x ULN\n  * Total bilirubin: ≤1.5x ULN\n  * Serum creatinine (Cr): ≤1.5x ULN\n  * Blood oxygen saturation (SpO2): ≥90%\n* Electrocardiogram (ECG): No abnormal findings requiring treatment are observed\n* Has freely given written informed consent to participate in the study\n* For females of reproductive potential: use of effective contraception during treatment and for at least 3 months after completion of mogamulizumab therapy. For males who have sexual intercourse with females of reproductive potential: use of effective contraception during treatment and for at least 3 months after completion of mogamulizumab therapy.\n\nExclusion Criteria:\n\nIn order to protect subjects and avoid any problems in evaluating the study drug, patients who meet any of the following criteria should be excluded from enrollment in the study, in either screening or treatment cohorts:\n\n* Patients with a history of any of the following:\n\n  * Neutrophil count: ≤1000\u002Fmm3, unless patient has diagnosis of ethnic neutropenia\n  * Acute or chronic hepatitis or hepatic cirrhosis, other than patients with positive antibodies and negative PCR as noted in criteria #11 and #12 below.\n  * Tuberculosis or with active tuberculosis\n  * Myocardial infarction within 12 months prior to the date of enrollment\n  * Allergic reaction to administration of antibody drug products\n  * Other cancers. Patients with a history of a localized solid tumor who received definitive, curative treatment and who have been without evidence of disease for 5 years prior to enrollment will be able to enroll in the study. Patients with radically resected basal cell carcinoma of the skin, squamous cell carcinoma (except malignant melanoma), noninvasive cervix carcinoma, carcinoma in situ in the gastrointestinal tract or corpus of the uterus, localized thyroid cancer, and localized renal cell carcinoma will be able to enroll in the study if they are determined to be completely cured, even if within 5 years of enrollment.\n* Prior treatment with immunosuppressants or interferon alpha products within 6 months prior to the date of enrollment\n* Serious complications (heart failure, lung disease, renal failure, hepatic failure, uncontrolled diabetes mellitus, etc.)\n* History of an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Any ailment that could be exacerbated by the administration of KW-0761, in the judgment of the Principal Investigator or co-Investigator\n* Diagnosis of ATL\n* Women who are pregnant, breastfeeding, who may be pregnant, or wish to bear children while receiving treatment or within 3 months of last dose of mogamulizumab\n* Patients who have taken multivitamins (Alinamin, vitamin C, etc.) or supplements such as fucoidan, catechin, and pentosan polysulfate within 2 weeks prior to the date of enrollment\n* Prior treatment with other study drugs within 4 months prior to giving informed consent\n* Complications of spinal cord compressive lesions such as cervical spine disease, disc herniation, and ossification of the yellow ligament\n* Uncontrolled psychiatric disorder, epilepsy, or dementia\n* Positive test for Hepatitis B surface antigen or HBV-DNA (using real-time PCR). Positive Hepatitis B core antibody is permitted if HBV-DNA PCR is negative and the patient remains on prophylaxis during study.\n* Positive test for Hepatitis C virus antibody, unless Hepatitis C PCR is negative.\n* Positive test for HIV antibody, unless undetectable HIV RNA \\> 6 months and CD4 within normal limits per institutional standard.\n* Patients considered unqualified to participate in the study by the Principal Investigator or co-Investigator",{"count":77,"type":21},134,[79],"PHASE2","The purpose of this study is to find out whether the study drug mogamulizumab is effective in preventing the development of adult T-cell leukemia\u002Flymphoma (ATL) in people who are at higher risk for this type of cancer because they are infected with the HTLV-1 virus and because of changes seen in some of their immune system cells called T-cells.",[82,83,27,84],"T-Cell Leukemia\u002FLymphoma, Adult","T-cell Leukemia\u002FLymphoma","Lymphoma",[82,83,86,84,87,88,89,90],"T-cell leukemia","Mogamulizumab","HTLV-1","Memorial Sloan Kettering Cancer Center","21-486","2026-03-03",{"date":93,"type":32},"2026-03-05",{"date":95,"type":32},"2024-11-15",{"date":97,"type":21},"2029-11-15",{"name":89,"class":39},7,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":51,"phases":112,"briefSummary":113,"conditions":114,"keywords":121,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":40},"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).","2 Years","90 Years",{"count":111,"type":21},60,[53,79],"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.",[115,116,117,118,119,120],"T Cell Lymphoma","T Cell Leukemia","T-cell Acute Lymphoblastic Leukemia","T-Cell Lymphoma of CNS","T Cell Prolymphocytic Leukemia","T Cell Childhood ALL",[122,123,124,125],"CAR-T","CD5","CD7","ETP-ALL","2024-11-10",{"date":128,"type":32},"2024-11-12",{"date":130,"type":32},"2024-07-10",{"date":132,"type":21},"2026-12-28",{"name":134,"class":39},"Essen Biotech"]