[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aggressive-nk-cell-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aggressive-nk-cell-leukemia":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,68,124],{"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":25,"conditions":26,"keywords":40,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100475822","phase-1-a-study-of-dr-01-in-subjects-with-large-granular-lymphocytic-leukemia-or-cytotoxic-lymphomas-100475822",false,"NCT05475925","A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas","A Multicenter, Open-Label, First-In-Human, Multiple Expansion Cohort, Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of DR-01 in Adult Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas","Inclusion Criteria (All Subjects):\n\n1. ≥18 years of age.\n2. Able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document.\n3. Sufficient key organ performance and coagulation.\n4. Female subjects of childbearing potential (postmenarcheal, has an intact uterus and at least one ovary, and is \\\u003C1 year postmenopausal) must agree to use a highly effective method of contraception from enrollment through at least 12 months after last dose of DR-01.\n5. Male subjects must agree to use acceptable effective method(s) of contraception.\n\n   Subjects with LGLL must also meet inclusion criteria 6 and 7.\n6. Must have discontinued at least one prior line of systemic therapy.\n7. Additional immunophenotypic and symptomatic criteria must be met.\n\n   Disease-specific Inclusion Criteria (Cytotoxic Lymphomas):\n\n   Subjects with cytotoxic lymphomas must also meet inclusion criteria 8,9, and 10.\n8. Subjects must have failed at least one prior systemic regimens.\n9. Availability of post-progression tissue sample or willingness to consent to a baseline biopsy.\n10. Histologically confirmed diagnosis of a cytotoxic lymphoma by a hematopathologist (according to the WHO 2016 classification \\[Swerdlow 2016\\]).\n11. For Part A only, evaluable disease is acceptable.\n12. For Part B2 only, evaluable by the following response criteria as documented during Screening:\n\n    1. For cytotoxic PTCL-NOS, ENKTL, MEITL, EATL, SPTCL - Subjects must have radiographically measurable disease by computed tomography (CT) or CT\u002Fpositron emission tomography (PET) scan defined as at least one node measuring \\>1.5 cm or measurable extranodal lesion of at least 1.0 cm in longest diameter to be evaluated by Lugano criteria (Cheson 2014).\n    2. For PCGDTCL, ET-CTCL, HVLPD, cytotoxic CuPTCL-NOS - Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen criteria (Olsen 2021) or have leukemic involvement that can be evaluated using modified TPLL response criteria (Staber 2019).\n    3. For HSTCL, ANKL, SysEBV TCL - Subjects with hepatosplenic disease without measurable disease by Lugano criteria (Cheson 2014) or leukemic involvement in BM or peripheral blood that is evaluable for response using a modified TPLL response criteria (Staber 2019).\n\nExclusion Criteria:\n\nDisease-specific Exclusion Criteria; LGLL and ANKL:\n\n1. A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).\n\n   The following exclusion criteria apply to all subjects:\n2. Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals.\n3. Active or suspected malignant central nervous system involvement.\n4. Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For disseminated intravascular coagulation).\n5. Active known second malignancy.\n6. Infection with human immunodeficiency virus (HIV) type 1 or 2 (HIV-1 or HIV-2).\n7. Hepatitis B infection (hepatitis B virus surface antigen \\[HBsAg\\] positive), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive, confirmed by HCV ribonucleic acid). Subjects with HCV with undetectable virus after treatment are eligible.\n8. History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II.\n9. Use of systemic corticosteroids at prohibited dose levels within 15 days prior to C1D1 (except for prophylaxis for radiodiagnostic contrast reactions and study-defined premedication) or use of other non-biological immunosuppressive drugs within 15 days or 5 half-lives (whichever is less) prior to C1D1.\n10. Any condition requiring hormonal therapy (except for contraception, hormone replacement therapy and hormonal prophylaxis for a prior malignancy).\n11. Any other medical or psychiatric condition, or laboratory abnormality that would increase the risk associated with study participation, in the opinion of the Investigator or Medical Monitor.\n12. Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, peripheral neuropathy, or hematologic parameters meeting inclusion criteria).\n13. Autologous HSCT within 40 days of C1D1, allogeneic HSCT within 90 days\n14. Any immunosuppressive therapy for GVHD for subjects who are post allogeneic HSCT.\n15. Major surgery within 28 days of C1D1 (requires more than local anesthesia or plexus blockade).","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a multicenter, first-in-human, Phase 1\u002F2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas",[27,28,29,30,31,32,33,34,35,36,37,38,39],"LGLL - Large Granular Lymphocytic Leukemia","Primary Cutaneous Gamma-Delta T-Cell Lymphoma","Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma","Hepatosplenic T-cell Lymphoma","Subcutaneous Panniculitis-Like T-Cell Lymphoma","Aggressive NK Cell Leukemia","Systemic EBV1 T-cell Lymphoma, if CD8 Positive","Hydroa Vacciniforme-Like Lymphoproliferative Disorder","Extranodal NK\u002FT Cell Lymphoma, Nasal Type","Enteropathy-Associated T-Cell Lymphoma","Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma","Cytotoxic PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)","Cutaneous PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)",[41,42,43,44,45,46,47,48,49,50,51,52,53,54],"LGLL","Cytotoxic","Lymphoma","ANKL","EATL","MEITL","ENKL","HSTCL","Leukemia","SPTCL","ENKTL","CTCL","PTCL-NOS","TCL","RECRUITING","2026-06-15",{"date":58,"type":59},"2026-06-17","ACTUAL",{"date":61,"type":59},"2022-07-13",{"date":63,"type":20},"2026-12",{"name":65,"class":66},"Dren Bio","INDUSTRY",37,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":75,"targetDuration":77,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":108,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"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":76,"type":20},1000,"10 Years","OBSERVATIONAL","The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma. Researchers will use the information from this database to learn more about how to improve outcomes for people with T-cell lymphoma.",[81,82,83,84,85,86,87,88,89,34,90,91,92,37,93,94,30,31,95,96,97,98,99,100,101,102,103,104,105,106,107],"T-cell Lymphoma","NK-Cell Lymphoma","T-cell Prolymphocytic Leukemia","T-cell Large Granular Lymphocytic Leukemia","Chronic Lymphoproliferative Disorder of NK Cells","Aggressive NK-cell Leukemia","Systemic Epstein-Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood (Disorder)","Systemic Epstein Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood","Chronic Active EBV Infection of T-and NK-Cell Type, Systemic Form","Adult T-cell Leukemia\u002FLymphoma","Extranodal NK\u002FT-cell Lymphoma, Nasal Type","Enteropathy-associated T-cell Lymphoma","Intestinal T-Cell Lymphoma, Not Otherwise Specified","Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract","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",[109,110,111,112,113],"23-190","T-cell lymphoma","Memorial Sloan Kettering Cancer Center","T-cell Lymphoma Master Repository","TCLMR","2026-05-18",{"date":116,"type":59},"2026-05-20",{"date":118,"type":59},"2023-07-27",{"date":120,"type":20},"2030-07-27",{"name":111,"class":122},"OTHER",26,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100505580","phase-1-safety-evaluation-study-for-patients-with-aggressive-nk-cell-leukemia-100505580","NCT05863234","Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia","Multicenter, Open-label, Dose-escalation Phase I\u002FII Study to Evaluate the Tolerability, Safety, Efficacy and Pharmacokinetics of Repeated Continuous Intravenous PPMX-T003 in Patients With Aggressive NK Cell Leukaemia (ANKL) (Physician-initiated Clinical Trial)","Inclusion Criteria:\n\n* Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria.\n\nExclusion Criteria:\n\n* Patients eligible to receive chemotherapy as treatment for ANKL","70 Years",{"count":133,"type":20},7,[23,24],"This is Phase I\u002FII Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.",[32],[138],"neoplasms","2025-04-25",{"date":141,"type":59},"2025-04-30",{"date":143,"type":59},"2023-09-21",{"date":145,"type":20},"2026-03-31",{"name":147,"class":122},"Hiroshima University Hospital",1]