[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-cell-prolymphocytic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-cell-prolymphocytic-leukemia":262},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,73,116,150,180,202,227],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":55,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100514411","a-registry-for-people-with-t-cell-lymphoma-100514411",false,"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.","ALL",{"count":18,"type":19},1000,"ESTIMATED","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.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"T-cell Lymphoma","NK-Cell Lymphoma","T-cell Prolymphocytic Leukemia","T-cell Large Granular Lymphocytic Leukemia","Chronic Lymphoproliferative Disorder of NK Cells","Aggressive NK-cell Leukemia","Systemic Epstein-Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood (Disorder)","Systemic Epstein Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood","Chronic Active EBV Infection of T-and NK-Cell Type, Systemic Form","Hydroa Vacciniforme-Like Lymphoproliferative Disorder","Adult T-cell Leukemia\u002FLymphoma","Extranodal NK\u002FT-cell Lymphoma, Nasal Type","Enteropathy-associated T-cell Lymphoma","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",[56,57,58,59,60],"23-190","T-cell lymphoma","Memorial Sloan Kettering Cancer Center","T-cell Lymphoma Master Repository","TCLMR","RECRUITING","2026-05-18",{"date":64,"type":65},"2026-05-20","ACTUAL",{"date":67,"type":65},"2023-07-27",{"date":69,"type":19},"2030-07-27",{"name":58,"class":71},"OTHER",26,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":101,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100421728","phase-1-study-of-oral-administration-of-lp-118-in-patients-with-relapsed-or-refractory-cll-sll-mds-mdsmpn-aml-cmml-2-mpn-bp-all-mf-nhl-rt-mm-or-t-pll-100421728","NCT04771572","Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS\u002FMPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.","A Phase 1\u002F1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of LP-118 in Subjects With Relapsed or Refractory Hematological Malignancies","Inclusion Criteria:\n\n1. Male or female subjects, ≥ 18 years of age at the time of Screening with the following exception as outlined below:\n\n   -For T cell and B cell ALL subjects with age between 13 - 18 years, their body weight shall be ≥ 40 kg.\n2. Eligible subject must have an advanced hematologic malignancy including:\n\n   Group 1:\n\n   Group 1a\n   * Relapsed or refractory low risk tumor lysis CLL\u002FSLL subjects (ALC \\\u003C 25 x 109 cells\u002FL and all lymph nodes \\\u003C 5 cm) who have received at least two prior therapies. Subjects may also have slowly progressed on irreversible BTK inhibitors while on treatment with these agents.\n   * For CLL\u002FSLL subjects who come off BCR antagonist treatment (BTK inhibitors, P13K inhibitors, etc.) allows washout for 2 days as these subjects, progress quickly after treatment discontinuation and then remain eligible (steroids may be given during these two days to allow disease control).\n\n   Group 1b\n   * Morphologically confirmed diagnosis of MF in accordance with the WHO 2016 revised criteria, that is relapsed, intolerant, and\u002For refractory and that, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits;\n   * Morphologically confirmed diagnosis of MDS\u002FMPN, excluding juvenile myelomonocytic leukemia (JMML), in accordance with WHO 2016 revised criteria, that is relapsed and\u002For refractory and that, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits;\n   * Chronic myelomonocytic leukemia (CMML) with \\\u003C9% blasts;\n   * Or atypical chronic myeloid leukemia (aCML) with Hgb \\> 10g\u002FdL, WBC count \\\u003C 50 x 109 cells\u002FL, \\\u003C10% immature circulating cells;\n   * Or MDS\u002FMPN with ring sideroblasts and thrombocytosis (MDS\u002FMPN-RS-T) with Hgb \\> 10g\u002FdL;\n   * Or myelodysplastic\u002Fmyeloproliferative neoplasm, unclassifiable (MDS\u002FMPN-UC)\n   * CMML-2 with 10-19% blasts as defined by WHO 2016 revised criteria that is relapsed and\u002For refractory to prior HMA therapy;\n   * Relapsed and\u002For refractory MPN-BP as defined by WHO 2016 revised criteria that is transformed MPN with \\>20% myeloid blasts in the peripheral blood or bone marrow, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits;\n   * MDS subjects with refractory anemia with excess blasts (MDS-EB; subtype MDS-EB-1 or MDS-EB-2) as defined by WHO 2016 revised criteria and\u002For MDS with high- or very high-risk (risk score \\> 4.5) per the Revised International Prognostic Scoring System (IPSS-R, refer to Appendix 11; Section 15.13) who have no available therapies known to provide clinical benefit;\n   * Relapsed or refractory AML subjects (including de novo AML, secondary AML evolving from MDS or MPN or other antecedent hematologic disorder, and therapy-related AML) as defined by WHO 2016 revised criteria, subjects who have no available therapies known to provide clinical benefits; subjects with prior BCL-2 inhibitor therapy are permitted. WBC needs to be ≤ 25 × 109 cells\u002FL at the time of initiating investigational therapy (hydroxyurea is allowed to control WBC prior to and during therapy).\n\n   Group 1c\n   * Relapsed or refractory low risk tumor lysis NHL (NHL histologies \\[MZL, FL, WM, DLBCL, ATLL, PTCL, AITL, ALCL, MCL\\] are to be included per the 2016 World Health Organization \\[WHO\\] criteria) subjects, must have histologically documented diagnosis of a non-Hodgkin lymphoma as defined in the WHO classification scheme. Subjects have received at least 2 prior therapies and have no available therapies known to provide clinical benefit; For subjects with indolent NHL (Grade 1\\~3a FL, MZL) who have received two prior systemic therapies and have relapsed or progressed according to 2014 Lugano;\n   * Low risk tumor lysis transformed follicular, MZL, WM (to large cell or aggressive lymphoma) subjects who must have received at least one prior systemic therapy for the transformed lymphoma (unless combination chemotherapy is not appropriate);\n   * Low risk tumor lysis Richter transformation (RT): previously treated CLL and biopsy-proven Richter transformation with DLBCL histology after receiving at least one regimen for RT;\n   * Relapsed or refractory multiple myeloma (MM) subjects who have received a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 and have no treatment options available known to provide clinical benefit;\n   * Low risk tumor lysis T-cell prolymphocytic leukemia (T-PLL) subjects who have received one therapy for this and are relapsed or refractory;\n\n   Group 1d\n   * Relapsed or refractory ALL with dexamethasone run-in \\[5 days, dexamethasone 10mg\u002Fm2 (divided BID)\\];\n   * Or r\u002Fr ALL in remission but with detectable MRD (MRD +) by any detection method per institution standard of practice;\n   * IT chemo (per institutional SOC) is permitted prior to LP-118 C1D1 dosing, and then concomitantly on treatment if in best interest of the subject;\n   * Relapsed or refractory ALL subjects with B cell phenotype who have received at least two prior therapeutic regimens (such as multi-agent chemotherapy and\u002For tyrosine kinase inhibitors including bosutinib, dasatinib, imatinib, nilotinib or ponatinib) and failed, or are currently ineligible\u002Fintolerant for CD19-based target therapy (e.g. Blinatumomab); Relapsed or refractory ALL subjects with T cell phenotype who have received at least one prior therapy and failed.\n   * Relapsed or refractory ALL subjects with age between 13 - 18 years and have body weight ≥ 40kg, ALL subjects with B cell phenotype who have received at least two prior therapeutic regimens (such as multi-agent chemotherapy and\u002For tyrosine kinase inhibitors including bosutinib, dasatinib, imatinib, nilotinib or ponatinib) and progressed, or are currently ineligible\u002Fintolerant for CD19-based target therapy (e.g. Blinatumomab); Relapsed or refractory ALL subjects with T cell phenotype who have received at least one prior therapy and progressed.\n\n   Group 2\n   * Relapsed or refractory intermediate and high risk tumor lysis CLL\u002FSLL subjects who have received at least two prior therapies;\n   * Relapsed or refractory intermediate and high risk tumor lysis NHL (NHL histologies \\[MZL, FL, WM, DLBCL, ATLL, PTCL, AITL, ALCL, MCL\\] are to be included per the 2016 World Health Organization \\[WHO\\] criteria) subjects, must have histologically documented diagnosis of a non-Hodgkin lymphoma as defined in the WHO classification scheme. Subjects have received at least 2 prior therapies and have no available therapies known to provide clinical benefit; For subjects with indolent NHL (Grade 1\\~3a FL, MZL) who have received two prior systemic therapies and have relapsed or progressed according to 2014 Lugano;\n   * Intermediate and high risk tumor lysis transformed follicular, MZL, WM (to large cell or aggressive lymphoma) subjects who must have received at least one prior systemic therapy for the transformed lymphoma (unless combination chemotherapy is not appropriate);\n   * Intermediate and high risk tumor lysis Richter transformation (RT): previously treated CLL and biopsy-proven Richter transformation with DLBCL histology after receiving at least one regimen for RT;\n   * Intermediate and high risk tumor lysis T-cell prolymphocytic leukemia (T-PLL) subjects who have received one therapy for this and are relapsed or refractory;\n3. For Group 1d ALL subjects only, white blood cell (WBC) count ≤ 25 × 109 cells\u002FL at the time of enrollment (glucocorticoids or hydroxyurea is permitted to control WBC count prior to and during therapy).\n4. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.\n5. Adequate cardiac function defined as shortening fraction of ≥ 40% by 2D echocardiogram without Doppler.\n6. Subject must have adequate bone marrow (independent of growth factor support), coagulation, renal, and hepatic function, per laboratory reference ranges at Screening as follows:\n\n   Bone marrow criteria:\n   * Group 1 (r\u002Fr low risk tumor lysis CLL\u002FSLL (ALC \\\u003C 25 x 109 cells\u002FL and all lymph nodes \\\u003C 5 cm), NHL, RT, MM, T-PLL):\n   * Absolute Neutrophil Count (ANC) ≥ 1 x 109\u002FL (An exception is for subjects with an ANC\\\u003C1 x 109\u002FL and bone marrow heavily infiltrated with underlying disease)\n   * Platelets ≥ 50 x 109\u002FL on day of screening (entry platelet count must be independent of transfusion with 14 days of screening);\n   * Hemostasis criteria: Activated partial thromboplastin time (APPT) and prothrombin time (PT) ≤ 1.5 × the upper limit of normal (ULN);\n   * Renal function criteria: Serum creatinine ≤ ULN (per local institution reference range) or Calculated creatinine clearance (Cr Cl) ≥ 60 mL\u002Fmin using 24-hour CrCl OR by Cockcroft-Gault formula using actual body weight.\n   * Hepatic function criteria: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN; bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin \\> 1.5 × ULN, per discussion between the Investigator and the Medical Monitor).\n7. Females of childbearing potential (i.e., non-postmenopausal for at least 2 years or surgically sterile) and non-sterile males must practice at least 1 of the following methods of birth control with their partner(s) throughout the study and for 90 days after discontinuing study drug:\n\n   * Total abstinence from sexual intercourse as the preferred lifestyle of the subject; periodic abstinence is not acceptable;\n   * Surgically sterile partner(s) by vasectomy, bilateral orchiectomy, bilateral tubal ligation, bilateral oophorectomy or hysterectomy;\n   * Intrauterine device;\n   * Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) associated with inhibition of ovulation initiated for at least 1 month prior to study drug administration.\n8. Females of childbearing potential must have a negative pregnancy result as follows:\n\n   * At Screening on a serum sample obtained within 7 days prior to the first study drug administration, and\n   * Prior to dosing on a urine or serum sample obtained on the first day of study drug administration if ithas been \\> 7 days since obtaining the serum pregnancy test results in Screening.\n   * If a urine pregnancy test at any timepoint during the study is positive or indeterminate, a serum pregnancy test will be performed for confirmation\n9. Male subjects must refrain from sperm donation, from initial study drug administration until 90 days after the last dose of study drug.\n10. Subject must be able to understand and voluntarily sign and date an informed consent form (ICF), approved by an IRB, prior to any protocol-related procedures.\n\nExclusion Criteria:\n\nA subject will not be eligible for study participation if he\u002Fshe meets any of the following criteria.\n\n1. Subjects who have undergone autologous\u002Fallogeneic hematopoietic stem cell transplantation (HSCT) therapy within 60 days of the first dose of LP-118, or subjects on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Subjects in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks. The use of topical steroids and\u002For up to 20 mg\u002Fday prednisone or equivalent systemic steroids for ongoing GVHD is permitted.\n2. Subject has a history of other malignancies within past 12 months that are active and could result in competing risks. These cases shall be discussed with the Medical Monitor with the exception below.\n\n   * Subject with breast cancer or prostate cancer on endocrine therapy with stable disease;\n   * Continuation of maintenance therapy in patients with adequately treated malignancy\n   * Adequately treated in situ carcinoma of the cervix uteri;\n   * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n   * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n   * Cancer with expected survival of 2 years or more or that will not confound evaluation of LP-118 treatment\n3. Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of LP-118, or has not recovered to ≤ Grade 2 clinically significant AEs of the previous therapy (excluding neuropathy):\n\n   * Any anti-neoplastic therapy including chemotherapy, hormonal therapy, radiotherapy, biologic or immunotherapy, targeted small molecule agents, etc. (corticosteroid therapy \\\u003C 20 mg\u002Fday prednisone equivalent according to institutional guidelines to treat disease associated symptoms are permitted);\n   * For MF subjects who come off JAK2 antagonists, allow washout for 2 days as these subject's progress quickly after treatment discontinuation and remain eligible (steroids may be given during these two days to allow disease control).\n   * Subjects in need of immediate cytoreduction should be excluded.\n   * Any investigational therapy.\n   * Live vaccines\n4. Subject has received the following medications, therapies, or natural products within 7 days prior to the first dose of LP-118:\n\n   * Cytochrome P450, family 3, subfamily A (CYP3A) strong inhibitors (itraconazole, etc.), or substrates (Appendix 19);\n   * Subject has received strong Cytochrome P450, family 3, subfamily A (CYP3A) inducers within 14 days prior to the first dose of LP-118 (Appendix 19);\n   * Grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit;\n   * There is a 28-day washout period required for subjects who have had prior CAR-T treatment if there is no evidence of cytokine release syndrome (CRS) or other adverse events related to the CAR-T treatment, per discussion with the Medical Monitor.\n5. Subject has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the Investigator, would adversely affect his\u002Fher participation in this study. Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the study, place the subject at unacceptable risk or interfere with the interpretation of the results. For subjects who have required surgical intervention for any above diseases within the past 6 months, a discussion with the Investigator and the Medical Monitor is needed.\n6. Subject has baseline prolongation of the heart rate-corrected QT (QTcF) interval ≥ 480 ms (calculated per Fridericia's formula \\[QTcF = QT\u002FRR (1\u002F3)\\])), a cardiovascular disability status of New York Heart Association Class ≥ 2 or associated other significant screening ECG or ultrasonic cardiogram abnormalities, per Investigator's judgement. For any subject with underlying RBBB or LBBB, cardiology review is needed to correct QTcF calculation using Sponsor recommended formula.\n7. Subject has significant a history of congenital long QT syndrome or Torsades de Pointes (TdP), uncontrolled or symptomatic arrhythmias, congestive heart failure, myocardial infarction, stroke, or intracranial hemorrhage within 6 months prior to the first dose of LP-118.\n8. Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n   * Uncontrolled active systemic infection (bacterial, fungal, viral);\n   * Known poorly controlled human immunodeficiency virus (HIV) or active hepatitis B or C infection (active hepatitis B defined as HbsAg positive, or HbcAb positive with detectable HBV DNA load; active hepatitis C defined as HCV antibody positive with HCV RNA positive);\n   * Unexplained fever \\> 38.5°C within 7 days prior to the first dose of study drug administration (at the discretion of the Investigator if the fever is considered attributed to the subject's malignancy or an explained infection may be enrolled).\n9. A female subject is pregnant or breast-feeding.\n10. Subject incapacity to swallow oral medications, with any malabsorption condition, known dysphagia, short-gut syndrome, gastroparesis, or other conditions that, in the opinion of the Investigator, may limit the ingestion or gastrointestinal absorption, distribution, metabolism and excretion of drugs administered orally.\n11. Subjects with known and active central nervous system (CNS) involvement at Screening.\n12. Subjects with known hypersensitivity to any of the components of LP-118 (see Investigators Brochure for a list of components).\n13. Subjects who are taking QT-prolonging drugs that are known to cause Torsades de Pointes (TdP) (See Appendix 17 for the list of medications that are associated with TdP). In the event a prohibited medication might cause TdP, the PI must first determine if the risk to benefit is in favor of the subject and then discuss with the Medical Monitor about that particular medication on a case-by-case basis.\n14. Major surgery within 14 days prior to the first dose of study drug.","13 Years",{"count":82,"type":19},100,"INTERVENTIONAL",[85],"PHASE1","This is a Phase 1, multi-center, open-label study with a dose-escalation phase (Phase 1a) and a cohort expansion phase (Phase 1b), to evaluate the safety, tolerability, and PK profile of LP-118 under a once daily oral dosing schedule in up to 100 subjects.",[88,89,90,91,92,93,94,95,96,97,98,99,100],"Non Hodgkin Lymphoma","Richter Transformation","Multiple Myeloma","T-cell-prolymphocytic Leukemia","Acute Myeloid Leukemia","Acute Lymphocytic Leukemia","Myeodysplastic Syndrome","Myelodysplastic\u002FMyeloproliferative Neoplasm","Myelofibrosis","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Chronic Myelomonocytic Leukemia-2","Myelodysplastic Neoplasm in Blast Phase",[102,103,104],"Hematological Malignancies","Relapsed","Refractory","2026-04-29",{"date":107,"type":65},"2026-05-05",{"date":109,"type":65},"2022-05-08",{"date":111,"type":19},"2027-12-31",{"name":113,"class":114},"Newave Pharmaceutical Inc","INDUSTRY",8,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":83,"phases":126,"briefSummary":128,"conditions":129,"keywords":135,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"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.","18 Years",{"count":125,"type":19},44,[127],"PHASE2","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.",[24,130,131,132,26,133,34,134],"Graft Versus Host Disease","Lymphoma, T-Cell","Peripheral T Cell Lymphoma","Cutaneous T Cell Lymphoma","Primary Cutaneous T-Cell Non-Hodgkin Lymphoma",[136,137,138,139],"stem cell transplant","graft versus host disease","lymphoma","leukemia","2026-04-10",{"date":142,"type":65},"2026-04-15",{"date":144,"type":65},"2026-02-12",{"date":146,"type":19},"2027-01-31",{"name":148,"class":71},"Jonathan Brammer",1,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":83,"phases":159,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100440031","phase-1-a-study-of-ruxolitinib-and-duvelisib-in-people-with-lymphoma-100440031","NCT05010005","A Study of Ruxolitinib and Duvelisib in People With Lymphoma","Phase I Multicenter Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T- or NK-Cell Lymphomas","Inclusion Criteria:\n\na) Pathologically-confirmed mature T-cell lymphomas at the enrolling institution.\n\nPermitted histologies include (for dose escalation and expansion):\n\ni) Stage ≥Ib CTCL, which has relapsed or progressed after at least two systemic therapies. In order to ensure balanced enrollment for patients with systemic T-cell lymphoma and CTCL, a maximum of 15 CTCL patients will be enrolled in expansion cohort.\n\nii) Systemic anaplastic large cell lymphoma that has relapsed after therapy containing brentuximab vedotin.\n\niii) T-cell prolymphocytic leukemia (treatment naïve permitted)\n\nFor the following histologies, patients are required to have received at least 1 prior therapy (dose escalation and expansion):\n\niv) T-cell large granular lymphocytic leukemia\n\nv) Aggressive NK-cell leukemia\n\nvi) Adult T-cell leukemia\u002Flymphoma\n\nvii) Extranodal NK\u002FT- cell lymphoma, nasal type\n\nviii) Enteropathy-associated T-cell lymphoma\n\nix) Monomorphic epitheliotropic intestinal t-cell lymphoma\n\nx) Hepatosplenic T cell lymphoma\n\nxi) Subcutaneous panniculitis-like T-cell lymphoma\n\nxii) Primary cutaneous anaplastic large cell lymphoma\n\nxiii) Primary cutaneous gamma\u002Fdelta T-cell lymphoma\n\nxiv) Primary cutaneous CD8-positive aggressive epidermotropic cytotoxic T-cell lymphoma\n\nxv) Peripheral T-cell lymphoma, not otherwise specified\n\nxvi) Angioimmunoblastic T cell lymphoma\n\nxvii) Follicular T-cell lymphoma\n\nxviii) Nodal peripheral T-cell lymphoma wih T follicular helper phenotype\n\nb) Nodal periphal T-cell lymphoma wih T follicular helper phenotype Specific for T-PLL and TFH lymphoma expansion: histologies must be pathologically confirmed at the enrolling institutions i) T-cell prolymphocytic leukemia (treatment naïve permitted) ii) T-follicular helper lymphomas (must have received at least 1 prior treatment)\n\nc) Age ≥18 years at time of enrollment\n\nd) Performance status, as assessed in the ECOG grading system, ≤2\n\ne) Laboratory criteria.\n\nLaboratory criteria\n\ni) For dose escalation phase:\n\n1. Absolute neutrophil count ≥1.0 K\u002FmcL (Note: growth factor is allowed)\n2. Platelet count ≥80 K\u002Fμl or ≥50 K\u002Fμl if due to lymphoma\n3. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n\ni. Creatinine clearance should be calculated per institutional standard\n\nd. Direct 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; or ≤ 5x ULN if due to lymphoma involvement\n\nii) For dose expansion phase and T-PLL\u002FTFH lymphoma expansion:\n\n1. Absolute neutrophil count ≥1.0 K\u002FmcL or ≥0.5 K\u002FmcL if due to lymphoma or ≥0.0 K\u002FmcL if due to T-PLL or large granular lymphocytic leukemia (LGL) (Note: growth factor is allowed).\n2. Platelet count ≥80 K\u002Fμl or ≥50 K\u002Fμl if due to lymphoma\n3. c. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n\ni. Creatinine clearance should be calculated per institutional standard d. Direct 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; or ≤ 5x ULN if due to lymphoma involvement\n\nf) Measurable disease, defined by at least one of the following:\n\n* Revised International Working Group Classification for systemic lymphoma19\n* Atypical T lymphocytes quantifiable by flow cytometry or morphology in the peripheral blood or bone marrow\n* mSWAT (Modified Severity Weighted Assessment Tool) \\>0\n\n  g) Ability to swallow pills\n\n  h) Women of reproductive potential\\* must have a negative serum or urine β human chorionic gonadotropin (βhCG) pregnancy test within 14 days of initiating therapy. All women of reproductive potential and all sexually active male patients must agree to use adequate methods of birth control (e.g. latex condoms) throughout the study and for 3 months after the last dose of study drug.\n  * 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).\n* The effects of duvelisib on conception, pregnancy, and lactation are unknown. Since duvelisib has not been evaluated in pregnant or nursing women, the treatment of pregnant women or women of childbearing potential who are not using a highly effective contraception is contraindicated.\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. Pregnant women. (Lactating women must agree not to breast feed while taking study medications).\n3. Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active GVHD requiring immunosuppression.\n\na. Prior allogeneic stem cell transplant may be allowed after discussion with MSK PI if no GVHD or immunosuppression is present at time of enrollment...\n\nd) Prior use of duvelisib or ruxolitinib if either agent was discontinued due to toxicity.\n\ne) Previous systemic anti-cancer therapy for TCL within 14 days of initiating study drug\n\na. 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 MSK Principal Investigator.\n\ni. Patients receiving treatment with single agent ruxolitinib or duvelisib may be allowed to enroll onto the study without a washout period\n\nb. Systemic corticosteroids must be tapered to 20mg\u002Fday or less prednisone (or equivalent) upon start of investigational treatment.\n\nc. Topical steroids for CTCL is permitted on study.\n\nf) Ongoing use of immunosuppressant medications, including corticosteroids greater than 20mg of prednisone or equivalent at the time of enrollment\n\ng) History of chronic liver disease, veno-occlusive disease, or current alcohol abuse\n\nh) Administration of a live vaccine within 6 weeks of first dose of study drug.\n\ni) Prior surgery or gastrointestinal condition that may adversely affect drug absorption (e.g., gastric bypass surgery, gastrectomy)\n\nj) Patients with HIV infection if they meet either of the below criteria:\n\ni. detectable viral load ii. undetectable viral load with CD4 count \\\u003C200 or not taking anti-retroviral medications.\n\nk) Patients with chronic hepatitis B or C as defined by positive hepatitis B or C serology:\n\n* 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 must receive hepatitis B prophylaxis until at least 6 months after completion of study drug(s).\n\n  l) Subjects with active CMV (defined as positive CMV PCR with clinical manifestations consistent with active CMV infection) and requiring therapy. Carriers will be monitored per institutional guidelines.\n\n  m) Unable or unwilling to receive prophylaxis against pneumocystis, herpes simplex virus, or herpes zoster\n\n  g) Use of medications or consumption of foods that are strong inducers or inhibitors of CYP3A\n* Such agents must be discontinued at least 2 weeks prior to study intervention\n* Patients who (after enrollment) require use of a strong CYP3A4 inhibitor to treat a fungal\u002Fmold infection will require dose reductions n) Receipt of treatment for tuberculosis within 2 years prior to enrollment\n\n  o) Receiving therapy for another primary malignancy (other than T-cell lymphoma).\n* Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.\n* Early-stage cutaneous basal cell and squamous cell carcinomas are permissible\n* Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy is potentially permissible after discussion with the MSK Principal Investigator.\n\n  p) Known central nervous system or meningeal involvement by TCL (in the absence of symptoms, investigation into central nervous system involvement is not required).\n\n  q) Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition) or any important medical illness that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study.",{"count":158,"type":19},70,[85],"This study will test the safety of ruxolitinib, given at one dose that does not change, and duvelisib, given at different doses, to find out what effects, if any, the study treatment has on people with relapsed or refractory NK-cell or T-cell lymphoma.\n\nThis study has three parts: dose escalation (Part 1), dose expansion (Part 2), and TFH\u002FT-PLL cohort expansion (Part 3).",[162,163,26,164],"T-cell Lymphomas","NK-Cell Lymphomas","T-cell Large Granular Lymphocyte Leukemia",[166,167,168,169,170,164,26],"mature T-cell lymphomas","Ruxolitinib","Duvelisib","Relapsed or Refractory","21-176","2026-04-06",{"date":173,"type":65},"2026-04-09",{"date":175,"type":65},"2021-08-12",{"date":177,"type":19},"2027-08",{"name":58,"class":71},9,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":83,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":149},"100616909","phase-1-phase-ibii-trial-of-cladribineruxolitinibvenetoclax-in-patients-with-relapsedrefractory-t-cell-prolymphocytic-leukemia-100616909","NCT07311746","Phase Ib\u002FII Trial of Cladribine\u002FRuxolitinib\u002FVenetoclax in Patients With Relapsed\u002FRefractory T-cell Prolymphocytic Leukemia","Inclusion Criteria:\n\n1. Patients must have histologically confirmed a diagnosis T-PLL that is relapsed or refractory after prior treatment.\n2. Age ≥ 18 years.\n\n   * Patients must not have had T-PLL directed chemotherapy or antibody therapy for 7 days prior to starting ruxolitinib. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol.\n   * Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n3. Adequate organ function as defined below:\n\n   * liver function (bilirubin \\\u003C 2mg\u002FdL, AST and ALT \\\u003C3 x ULN - or ≤5 x ULN if related to leukemic involvement);\n   * kidney function (estimated creatinine clearance \\> 50);\n   * known cardiac ejection fraction of ≥ 45% within the past 3 months prior to enrolling on the trial;\n   * Platelet count of ≥ 30,000 (unless determined to be due to disease involvement).\n4. ECOG performance status of ≤ 2.\n5. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n6. Patients with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n7. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n\n   The effects of ruxolutinib on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n   * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n   * History of hysterectomy or bilateral salpingo-oophorectomy.\n   * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n   * History of bilateral tubal ligation or another surgical sterilization procedure.\n8. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), IUD, Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n9. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of ruxolitinib and venetoclax administration.\n10. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n\nExclusion Criteria:\n\n1. Pregnant women are excluded from this study because the agent used has the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.\n2. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant or cardiac arrhythmia\n3. Patient with documented hypersensitivity to any of the components of the therapy program.\n4. Patients with known active, uncontrolled CNS leukemia will not be eligible.\n5. Patients with prior treatment with a JAK1, JAK2, or JAK3 inhibitor will not be eligible.\n6. Men and women of childbearing potential who do not practice contraception.\n7. Known history of active HIV infection (HIV 1\u002F2 antibodies).\n8. Active HBV or HCV infection that requires treatment or at risk for HBV reactivation.\n\n   Hepatitis B virus DNA and HCV RNA must be undetectable upon testing. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.\n9. Patients who are receiving any other investigational agents.\n10. Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":187,"type":19},36,[85,127],"The goal of this clinical research study is to learn if the combination of ruxolitinib with cladribine and venetoclax can help to control the disease in patients with R\u002FR T-PLL.",[26,191],"Refractory T-Cell Prolymphocytic Leukemia","NOT_YET_RECRUITING","2025-12-29",{"date":195,"type":65},"2025-12-31",{"date":197,"type":19},"2026-06-01",{"date":199,"type":19},"2031-01-31",{"name":201,"class":71},"M.D. Anderson Cancer Center",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":83,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":149},"100578398","phase-1-duvelisib-and-venetoclax-in-patients-with-relapsed-or-refractory-peripheral-t-cell-lymphoma-ptcl-100578398","NCT06810778","Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","Phase I\u002FII Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)","Inclusion Criteria:\n\n* Phase I: Histologically confirmed relapsed\u002Frefractory PTCL, except the following lymphoma subtypes: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL).\n* Phase II: same as phase I\n* Disease that has progressed during or relapsed after at least two previous therapies.\n* ECOG performance status ≤ 2\n* Adequate hepatic function defined as:\n\n  o Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin\n* Adequate renal function as defined by:\n\n  o Creatinine clearance ≥ 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection\n* Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement confirmed on biopsy:\n\n  * Absolute neutrophil count ≥ 1500 cells\u002Fmm3 (1.5 x 109\u002FL) or ≥ 1000 cells\u002Fmm3 (1.5 x 109\u002FL) with bone marrow involvement. Growth factor use is allowed in order to achieve this\n  * Platelet count ≥ 50,000 cells\u002Fmm3 (50 x 109\u002FL) independent of transfusion within 7 days of screening\n  * Hemoglobin ≥8 g\u002FdL (without transfusion support.)\n\nExclusion Criteria:\n\n* Phase I and Phase II:\n\n  * Patients eligible for Hematopoietic stem cell transplantation (HSCT)\n  * Cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL)\n  * Suspected and confirmed central nervous system involvement\n  * Previous treatment with venetoclax or a PI3K inhibitor.\n  * Active malignancy other than NHL requiring ongoing therapy, with the exception of hormonal therapy (i.e. castration-sensitive prostate cancer stable on testosterone blockade)\n  * Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, surgery) within 2 weeks of Cycle 1\u002FDay 1 with the following exceptions:\n\n    * For patients on targeted therapies, a washout of least five half-lives is required\n    * Patients who experience clinical deterioration may start therapy after a shorter washout period with prior approval by the PI\n    * Corticosteroid therapy (prednisone or equivalent \\\u003C20 mg daily) is allowed\n    * Patients with multiple basal cell carcinomas that undergo sequential Moh's excisions with interim observation\n  * Allogeneic hematologic stem cell transplant within 6 months of starting study treatment or active graft vs. host disease (GVHD) requiring treatment or prophylaxis\n\n    o Patients with a history of an allogeneic stem cell transplant \\> 6 months prior to starting study treatment should be stable, off of immunosuppression for at least 2 months.\n  * Any active systemic infection requiring systemic antibiotics or other uncontrolled, active infections\n  * Positive Human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) antibody test\n\n    o For HCV and HBV, patients with evidence of prior infection also excluded\n  * Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n    * Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n    * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate\n  * Uncontrolled, not disease-related autoimmune hemolytic anemia or ITP\n  * History of stroke or intracranial hemorrhage\n  * History of severe bleeding disorder (hemophilia A or B, von Willebrand disease (VWD)), history of spontaneous bleeding requiring blood transfusions or other medical intervention, history of life-threatening hemorrhage within 3 months of first dose.\n  * Currently active gastrointestinal disease, including colitis, inflammatory bowel disease and diarrhea requiring therapy\n  * Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment\n  * Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina\n  * Use of Coumadin for anticoagulation (other anticoagulants permitted)\n  * Lactating or pregnant\n  * Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction resulting in malabsorption or chronic diarrhea\n  * Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A (see Appendix D)\n  * Treatment with any of the following within 7 days prior to the first dose of study drug:\n  * Steroid therapy for anti-neoplastic intent (defined as prednisone or equivalent \\>20 mg daily)\n  * Moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Appendix D for examples)\n  * Moderate or strong CYP3A inducers (see Appendix D for examples)\n  * Administration or consumption of any of the following within 7 days prior to the first dose of study drug:\n\n    * Grapefruit or grapefruit products\n    * Seville oranges (including marmalade containing Seville oranges)\n    * Star fruit",{"count":210,"type":19},12,[85,127],"This is an open-label, phase I\u002FII study of duvelisib in combination with Venetoclax for patients with relapsed\u002Frefractory NHL. Duvelisib is an FDA approved, marketed product used to treat certain patients with leukemia and lymphoma and Venetoclax, which is approved for treatment of certain patients with acute myeloid leukemia. The combination of these two drugs is experimental. Experimental means that it is not approved by the United States Food and Drug Administration (FDA). The researchers want to find out how safe it is to combine these drugs and how well this combination can work for your cancer.",[91,214],"Cutaneous T-Cell Lymphoma Refractory",[139,216,217],"refractory","relapsed","2025-07-11",{"date":220,"type":65},"2025-07-15",{"date":222,"type":65},"2025-05-02",{"date":224,"type":19},"2031-06-01",{"name":226,"class":71},"Jonsson Comprehensive Cancer Center",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":235,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":83,"phases":239,"briefSummary":240,"conditions":241,"keywords":248,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":149},"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":238,"type":19},60,[85,127],"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.",[242,243,244,245,246,247],"T Cell Lymphoma","T Cell Leukemia","T-cell Acute Lymphoblastic Leukemia","T-Cell Lymphoma of CNS","T Cell Prolymphocytic Leukemia","T Cell Childhood ALL",[249,250,251,252],"CAR-T","CD5","CD7","ETP-ALL","2024-11-10",{"date":255,"type":65},"2024-11-12",{"date":257,"type":65},"2024-07-10",{"date":259,"type":19},"2026-12-28",{"name":261,"class":71},"Essen Biotech","T-Cell Prolymphocytic Leukemia"]