[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoma-t-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoma-t-cell":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,70,93,128,164,197,221,243,266,298],{"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":35,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100370548","phase-1-a-study-of-tulmimetostat-dzr123-cpi-0209-in-patients-with-advanced-solid-tumors-and-lymphomas-100370548",false,"NCT04104776","A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","A Phase 1\u002F2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","Key Inclusion Criteria:\n\nAll Patients:\n\n* Adults aged ≥18 years with life expectancy ≥12 weeks\n* ECOG performance status 0-1\n* Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)\n* Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds\n* Willingness to provide tumor tissue and blood samples for biomarker analyses\n* Agreement to protocol-specified contraception requirements\n* Signed informed consent prior to study procedures\n\nDisease-Specific Inclusion Criteria:\n\nPhase 1 (Dose Escalation):\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma\n* Disease refractory to standard therapy or with no available effective standard treatment\n* For prostate cancer: castrate testosterone levels maintained throughout the study\n\nPhase 2 (Disease-Specific Cohorts):\n\n* M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements)\n* M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated)\n* M3: ARID1A mutant recurrent\u002Fmetastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy\n* M4: Relapsed\u002Frefractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease\n* M5: Relapsed\u002Frefractory pleural or peritoneal mesothelioma with documented BAP1 loss\n* M6: Metastatic castration-resistant prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy\n* M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort)\n* M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure\n\nKey Exclusion Criteria:\n\nAll Patients:\n\nMedical Conditions:\n\n* Prior solid organ or allogeneic hematopoietic cell transplant\n* Active or untreated symptomatic CNS metastases (with limited exceptions)\n* Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled infections or significant gastrointestinal disorders affecting absorption\n* Active HIV or hepatitis B\u002FC infection\n* Concurrent malignancy requiring active treatment (with protocol-defined exceptions)\n* Pregnancy, breastfeeding, or inability to comply with protocol requirements\n\nPrior or Concomitant Therapy:\n\n* Recent anticancer therapy within protocol-defined washout periods\n* Prior EZH2 inhibitor treatment\n* Recent radiation or liver-directed therapies outside allowed windows\n* Use of strong CYP3A4\u002F5 inhibitors or inducers\n\nAdditional Cohort-Specific Exclusions:\n\n* M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies\n* M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease","ALL","18 Years",{"count":19,"type":20},275,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.",[27,28,29,30,31,32,33,34],"Advanced Solid Tumor","Diffuse Large B Cell Lymphoma","Lymphoma, T-Cell","Mesothelioma, Malignant","Prostatic Neoplasms, Castration-Resistant","Endometrial Cancer","Ovarian Clear Cell Carcinoma","Metastatic Castration-resistant Prostate Cancer",[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,32,33,53,54,55,56],"Tulmimetostat","DZR123","Lymphoma, Large B-Cell, Diffuse","Lymphoma, B-cell","Lymphoma, T-cell","Lymphoma, Non-Hodgkin","Lymphoma","Neoplasms by Site","Neoplasms by Histologic Type","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Topoisomerase Inhibitors","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents","Food effect","Adenine-thymine (AT)-rich interactive domain-containing protein 1A (ARID1A)","ARID1A wildtype (ARID1A WT) endometrial carcinoma","Metastatic castration-resistant prostate cancer (mCRPC)","RECRUITING","2026-06-17",{"date":60,"type":61},"2026-06-22","ACTUAL",{"date":63,"type":61},"2019-09-18",{"date":65,"type":20},"2030-02-27",{"name":67,"class":68},"Novartis Pharmaceuticals","INDUSTRY",81,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100474850","phase-1-a-phase-12-study-of-stp938-dencatistat-for-adult-subjects-with-relapsedrefractory-b-cell-and-t-cell-lymphomas-100474850","NCT05463263","A Phase 1\u002F2 Study of STP938 (Dencatistat) for Adult Subjects With Relapsed\u002FRefractory B-Cell and T-Cell Lymphomas","An Open-Label, First in Human, Phase 1\u002F2 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the CTPS1 Inhibitor STP938 In Adult Subjects With Relapsed\u002FRefractory B-Cell and T-Cell Lymphomas","Main Inclusion Criteria:\n\n* Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization.\n* Male or female aged ≥ 18 years.\n* Relapsed\u002Frefractory patients with histologically confirmed diagnosis of B cell or T cell lymphoma\n* Must have received at least 2 prior systemic therapies and have no treatment options known to provide clinical benefit\n* Must have measurable disease per Lugano lymphoma classification except for cutaneous T-cell lymphoma (CTCL) which is measured via International Society for Cutaneous Lymphomas (ISCL)\u002F European Organization of Research and Treatment of Cancer (EORTC).\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n* Life expectancy \\> 3 months as assessed by the Investigator.\n* Adequate organ function (bone marrow, hepatic, renal function and coagulation).\n* All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment.\n\nMain Exclusion Criteria:\n\n* Pregnant or breastfeeding females and women of child bearing potential or males unwilling to comply with contraception requirements.\n* Known carcinomatous meningitis or central nervous system (CNS) involvement with lymphoma.\n* Active malignancy within 2 years of study enrollment\n* Prior radiation or surgical resection of their lymphoma without additional sites of measurable disease outside of the radiation field or subjects who have received prior radiation or surgical resection of their lymphoma ≤2 weeks prior to the first dose of study drug.\n* Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or \\\u003C5 half-lives since completion of previous investigational therapy, whichever is shorter.\n* Uncontrolled intercurrent illness.\n* Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months.\n* Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.\n* Subjects who have received a live vaccine within 30 days prior to study enrollment or whilst participating in the study.\n* Subjects with corrected QT interval \\>470 msec based on averaged triplicate electrocardiogram (ECG) readings at the Screening Visit using the QT interval corrected for heart rate using Fridericia's method (QTcF).\n* Subjects who received a severe acute respiratory syndrome coronavirus 2 vaccine ≤3 weeks prior to study drug dosing.",{"count":78,"type":20},180,[23,24],"The Phase 1 part of the study is a dose escalation of STP938 as monotherapy.\n\nThe Phase 2 part of the study is cohort expansion of STP938 as a monotherapy in 5 different B and T cell lymphomas.",[82,29],"Lymphoma, B-Cell","2026-06-13",{"date":85,"type":61},"2026-06-16",{"date":87,"type":61},"2022-08-03",{"date":89,"type":20},"2026-12",{"name":91,"class":68},"Step Pharma, SAS",15,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":103,"conditions":104,"keywords":112,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":127},"100620332","phase-2-ruxolitinib-maintenance-post-hematopoietic-stem-cell-transplant-t-cell-lymphoma-100620332","NCT07356245","Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma","Phase II Study of Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant in T-Cell Lymphoma","Inclusion Criteria:\n\n1. Adult patients with T-cell lymphoma \\[PTCL (all subtypes), T-PLL, ATLL, and CTCL (all subtypes)\\] in partial or complete remission between day +35 and +120 from auto-SCT or allo-SCT\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less\n3. Adequate hematologic function defined by absolute neutrophil count (ANC) \\> 1000\u002Fmm3 without granulocyte colony-stimulating factor (G-CSF) for at least 3 days, platelets \\> 50K\u002Fmm3 without transfusion for at least 3 days and hemoglobin (Hb) \\> 8.0 g\u002FdL without transfusion for at least 3 days.\n4. Adequate organ function defined by total Bilirubin \\\u003C 1.5 x ULN, alanine aminotransferase (ALT) \\\u003C\u002F= 3 x ULN, CKD-EPI eGFR ≥ 30 ml\u002Fmin, SpO2 \\> 92% without supplemental oxygen.\n5. Able to tolerate oral or enteral medications.\n6. Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.\n7. Able to read and sign informed consent.\n\nExclusion Criteria:\n\n1. Anaplastic lymphoma kinase (ALK)+ or Dual specificity 22 (DUSP22)+ ALCL with low international prognostic index (IPI) score (\\\u003C2) in first complete remission.\n2. Progressive disease or any other systemic therapy post-SCT (radiation allowed)\n3. Disease progression to Ruxolitinib previously\n4. GvHD requiring systemic therapy.\n5. Active uncontrolled infections.\n6. Active thrombotic active microangiopathy requiring therapy.\n7. History of veno-occlusive disorder post-transplant\n8. Use of platelets antiaggregant or anticoagulants deemed to be unsafe to be held in case of thrombocytopenia.\n9. History of life-threatening bleeding defined as any bleeding that required invasive procedures or involving central nervous system.\n10. Pregnancy (positive Beta HCG test in a woman with childbearing potential defined as not postmenopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.\n11. Uncontrolled Hepatitis B\u002FC, HIV, tuberculosis, mycobacterium, or fungal infection.\n12. Exposure to other investigational drugs within 4 weeks before enrollment.\n13. Grade ≥ 3 non-hematologic toxicity from SCT that has not resolved to grade ≤ 2.\n14. Myocardial infarction or stroke within 1 year of study entry.\n15. Any uncontrolled medical problem at the discretion of the investigator that would pose a risk to the patient.",{"count":101,"type":20},44,[24],"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.",[105,106,29,107,108,109,110,111],"T-cell Lymphoma","Graft Versus Host Disease","Peripheral T Cell Lymphoma","T-cell Prolymphocytic Leukemia","Cutaneous T Cell Lymphoma","Adult T-cell Leukemia\u002FLymphoma","Primary Cutaneous T-Cell Non-Hodgkin Lymphoma",[113,114,115,116],"stem cell transplant","graft versus host disease","lymphoma","leukemia","2026-04-10",{"date":119,"type":61},"2026-04-15",{"date":121,"type":61},"2026-02-12",{"date":123,"type":20},"2027-01-31",{"name":125,"class":126},"Jonathan Brammer","OTHER",1,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":139,"conditions":140,"keywords":147,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":163},"100559201","phase-3-soquelitinib-vs-standard-of-care-in-participants-with-relapsedrefractory-peripheral-t-cell-lymphoma-not-otherwise-specified-follicular-helper-t-cell-lymphomas-or-systemic-anaplastic-large-cell-lymphoma-100559201","NCT06561048","Soquelitinib vs Standard of Care in Participants With Relapsed\u002FRefractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma","A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physician's Choice Standard of Care Treatment (Selected Single Agent) in Participants With Relapsed\u002FRefractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma","Inclusion Criteria:\n\n1. Adult participants ≥18 years of age on the day of signing the informed consent form.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n3. Histologically confirmed PTCL-NOS, FHTCLs or sALCL per The International Consensus Classification of Mature Lymphoid Neoplasms.\n4. Progressed on, be refractory to, relapsed, or intolerant to standard therapy for their cancer. At least 1 but not more than 3 prior systemic therapies.\n5. Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm by computed tomography, as assessed by the site radiologist.\n6. Life expectancy \\>12 weeks.\n7. Adequate organ function as determined by:\n\n   * Absolute neutrophil count ≥ 1.0×10\\^9\u002FL (1000\u002Fmm3) (without receiving granulocyte-colony stimulating factor)\n   * Platelet count ≥ 100×10\\^9\u002FL (without transfusion)\n   * Hemoglobin ≥ 9.0 g\u002FdL, without packed red blood cell transfusion within the last 1 week of starting study drug\n   * Prothrombin time international normalized ratio and partial thromboplastin time ≤1.5 × upper limit of normal (ULN), unless participant is receiving anticoagulant therapy and prothrombin time or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants\n   * Calculated creatinine clearance (CrCl) according to Cockcroft-Gault formula and based on ideal body weight or 24-hour urine CrCl ≥ 50 mL\u002Fminute\n   * Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN. For participants with Gilbert's disease: ≤ 3.0 mg\u002FdL or discussion with the Medical Monitor\n   * Aspartate aminotransferase and alanine transaminase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)\n   * Serum albumin \\> 2.5 g\u002FdL\n   * Serum calcium \\\u003C 12 mg\u002FdL or corrected serum calcium \\\u003C ULN\n8. Must have recovered from all AEs due to previous therapies to Grade ≤ 1 or baseline except for the following:\n\n   * Grade ≤ 2 neuropathy\n   * Alopecia and non-acute toxicities\n   * If major received major surgery, then must have recovered adequately per the investigator from the toxicity and\u002For complications from the intervention prior to starting study treatment\n9. Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 highly effective method of contraception from the time of screening and must agree to continue using such precautions for 120 days after the last dose of study drug for participants who receive soquelitinib, or 6 months after the last dose for participants who receive either belinostat or pralatrexate.\n10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom plus spermicide from Day 1 through 120 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Participants who have T-cell lymphoma with active central nervous system involvement.\n2. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.\n3. History of primary immunodeficiency or sold organ transplantation.\n4. History of opportunistic infection within 30days of screening requiring active systemic treatment or active infection requiring IV therapy.\n5. Any active infection requiring IV therapy.\n6. History of invasive prior malignancy that required systemic therapy within last 3 years.\n7. Any condition that confounds the ability to interpret data from the study.\n8. Known to be positive for HIV, or positive test for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \\[HBsAg\\]) or positive test for hepatitis C antibody.\n9. Monoclonal antibody therapy for cancer, radiotherapy, or chemotherapy within 3 weeks and targeted therapy within 2 weeks prior to the first dose of study treatment.\n10. Prior administration of an ITK inhibitor.\n11. Participants who need immediate cytoreductive therapy.\n12. Participants requiring the concomitant use of strong inhibitors or inducers of CYP3A or who have received these within 5 half-lives or 14 days prior to the start of study treatment.\n13. History of allogeneic hematopoietic stem cell transplantation.\n14. Candidate for hematopoietic stem cell transplantation at screening.\n15. History of progressive disease within 6 months of autologous hematopoietic stem cell transplantation.\n16. Concurrent enrollment in another clinical study\n17. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study, starting with the screening visit through 6 months after the last dose of study treatment.\n18. Participants who cannot ingest medications orally or who have malabsorption.",{"count":136,"type":20},150,[138],"PHASE3","A Phase 3, randomized, 2-arm, open-label, multicenter, stratified study of soquelitinib versus physician's choice standard of care (SOC) treatment (selected single agents) in participants with relapsed\u002Frefractory (R\u002FR) peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), follicular helper T-cell lymphomas (FHTCLs), or systemic anaplastic large-cell lymphoma (sALCL).",[141,142,143,144,145,146,29],"Peripheral T-Cell Lymphoma, Not Otherwise Specified","Angioimmunoblastic T-cell Lymphoma","Follicular T-Cell Lymphoma","Nodal Peripheral T-Cell Lymphoma With TFH Phenotype","Systemic Anaplastic Large Cell Lymphoma","Lymphoma, T-Cell, Peripheral",[148,149,150,151,152,153],"Peripheral T-Cell Lymphoma, Not Otherwise Specified (PTCL-NOS)","Follicular Helper T-Cell Lymphoma (FHTCL)","Angioimmunoblastic T-cell Lymphoma (AITL)","Follicular T-Cell Lymphoma (FTCL)","Nodal Peripheral T-Cell Lymphoma with T Follicular Helper Phenotype (PTCL-Tfh)","Systemic Anaplastic Large Cell Lymphoma (sALCL)","2026-04-02",{"date":156,"type":61},"2026-04-08",{"date":158,"type":61},"2024-10-02",{"date":160,"type":20},"2028-12",{"name":162,"class":68},"Corvus Pharmaceuticals, Inc.",34,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":184,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100571162","phase-2-jak1-inhibitor-golidocitnib-for-the-treatment-of-relapsedrefractory-indolent-tnk-cell-lymphomas-100571162","NCT06716658","JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed\u002FRefractory Indolent T\u002FNK-cell Lymphomas","Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed\u002FRefractory Indolent T\u002FNK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years, with no restrictions on gender;\n2. Histologically confirmed relapsed\u002Frefractory (R\u002FR) indolent T\u002FNK-cell; lymphoma that has failed at least one systemic therapy or is intolerant to such treatment and\u002For currently has no effective standard treatment options;\n3. The patient meets the criteria for appropriate therapeutic indications;\n4. ECOG performance status of 0-2;\n5. Adequate organ function, defined as: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Blood urea nitrogen (BUN)\u002FUrea and creatinine (Cr) ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 50%; Fridericia-corrected QT interval (QTcF): \\\u003C 450 ms for males, \\\u003C 470 ms for females;\n6. An expected survival time of at least 3 months;\n7. Male and female subjects of childbearing potential must agree to use effective contraception throughout the study period and for 6 months after the last dose of the investigational drug;\n8. A washout period of ≥ 4 weeks since receiving any prior antitumor therapies (including radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy) before participating in this study;\n9. The subject has not participated in any other clinical trial within 1 month prior to enrollment;\n10. The subject agrees to and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects who have previously used any JAK inhibitors;\n2. Subjects with clinical conditions such as dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and\u002For absorption of the study drug;\n3. Subjects with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);\n4. Subjects with HBV or HCV infections, defined as HBsAg and\u002For HBcAb positivity and HBV DNA copy number ≥ the upper limit of normal (ULN), or acute or chronic active hepatitis C (HCV antibody-positive);\n5. Subjects with a history of immunodeficiency, including those who are HIV-positive, or those with other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or a history of allogeneic bone marrow or hematopoietic stem cell transplantation;\n6. Subjects who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;\n7. Subjects with severe or uncontrolled cardiovascular diseases;\n8. Subjects with severe concomitant diseases that pose a significant risk to patient safety or, in the investigator's judgment, may interfere with the completion of the study (e.g., uncontrolled hypertension, diabetes, or thyroid disorders);\n9. Pregnant or breastfeeding female subjects, or baseline positive pregnancy test results in women of childbearing potential;\n10. Subjects with a history of other malignancies diagnosed or treated within the past 5 years;\n11. Any other conditions that, in the investigator's opinion, render the subject unsuitable for participation in the study.",{"count":172,"type":20},48,[24],"Indolent T\u002FNK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T\u002FNK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T\u002FNK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed\u002Frefractory indolent T\u002FNK-cell lymphomas. Patients will be treated with Golidocitnib, with an expected overall response rate of 60% for JAK1 inhibitor Golidocitnib treatment.",[29,176,177,109,178,179,180,181,182,183],"NK-LGL Leukemia","T-LGL Leukemia","Cutaneous T Cell Lymphoma (CTCL)","Large Granular Lymphocyte Leukemia","Large Granular Lymphocytic Leukemia","Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract","Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma","Mycosis Fungoides",[185,186],"Indolent T\u002FNK-cell lymphomas","JAK1 inhibitor","2025-11-14",{"date":189,"type":61},"2025-11-18",{"date":191,"type":61},"2024-12-25",{"date":193,"type":20},"2028-11-15",{"name":195,"class":126},"Institute of Hematology & Blood Diseases Hospital, China",2,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100557126","phase-2-mb-105-in-patients-with-cd5-positive-t-cell-lymphoma-100557126","NCT06534060","MB-105 in Patients With CD5 Positive T-cell Lymphoma","A Phase 2, Open-label, Multicenter Study of MB-105 in Patients With CD5 Positive (CD5+) Relapsed \u002F Refractory T-cell Lymphoma (r\u002Fr TCL).","Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age.\n2. Patients with r\u002Fr TCL per WHO 2022 criteria.\n\n   1. r\u002Fr CTCL that has failed ≥ 2 prior lines of standard of care (SoC) therapy.\n   2. r\u002Fr PTCL that has failed ≥ 1 prior lines of SoC therapy. Note: patients with CD30+ disease should have received brentuximab vedotin.\n3. Has available tumor tissue or is willing to undergo a biopsy procedure.\n4. CD5 positivity confirmed by local laboratory using an approved diagnostic test or LDT. CD5 positivity is currently defined as having ≥ 50% CD5 expression. An exploratory cohort will enroll patients with CD5 expression below 50%.\n5. Karnofsky performance score ≥ 70% or higher.\n6. Prior CAR T-cell therapy must have occurred \\> 60 days prior to study enrollment and must have no evidence of CAR persistence.\n7. Measurable or detectable disease\n\n   1. PTCL per Lugano criteria\n   2. CTCL per Global (ISCL\u002FEORTC\u002FUSCCL) criteria.\n8. Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) must have occurred more than 60 days prior to study enrollment.\n9. Adequate bone marrow function defined as:\n\n   1. Absolute neutrophil count (ANC) ≥ 1500\u002FμL (≥ 1000\u002FμL for patients with prior HSCT or marrow involvement)\n   2. Absolute lymphocyte count ≥200 cells\u002FμL\n   3. Hemoglobin ≥ 8 g\u002FdL (transfusion permitted)\n   4. Platelet count ≥ 75 000\u002FμL (≥50 000\u002FμL for patients with marrow involvement).\n10. Organ function as follows:\n\n    1. Cardiac: left ventricular ejection fraction (LVEF) ≥ 50% by Echo or radionuclide scan.\n    2. Pulmonary: oxygen saturation ≥ 92% (room air).\n    3. Renal: calculated creatinine clearance \\> 30 mL\u002Fmin.\n    4. Liver:\n\n       * Total bilirubin \\\u003C 1.5 x ULN (\\\u003C 2 × upper limit of normal (ULN)) if liver involvement).\n       * If no liver involvement and total bilirubin ≥1.5 x ≤ ULN, direct bilirubin \\\u003C ULN (Gilbert syndrome)\n       * Aspartate aminotransferase \u002F alanine aminotransferase \\\u003C 3 × ULN (5 x ULN if liver involvement).\n       * Albumin \\> 2.5 g\u002FdL.\n11. For females of childbearing potential (defined as \\\u003C 24 months of amenorrhea or not surgically sterile \\[absence of ovaries and\u002For uterus\\]), a negative serum pregnancy test must be documented at screening, and prior to lymphodepletion (conditioning).\n12. For females of childbearing potential and males, a highly effective method of contraception together with a barrier method must be used from the start of lymphodepletion (conditioning) and for at least 12 months after the last dose of study agent.\n\nExclusion Criteria:\n\n1. Sezary syndrome. For other tumor types, if there is a suspicion of significant circulating disease at time of leukapheresis, discuss eligibility with medical monitor prior to proceeding.\n2. Contraindication to leukapheresis.\n3. Prior treatment with any CD5-targeted therapy.\n4. Any evidence of the following active viral infections:\n\n   1. HIV infection.\n   2. Chronic hepatitis B virus (cHBV) infection with detectable viral load. Patients with cHBV, who are receiving anti-viral prophylaxis, may be enrolled if they are asymptomatic for \\>5 days prior to signing informed consent (ICF).\n   3. Hepatitis C (HCV) infection with detectable viral load. Patients cured of HCV may be enrolled.\n5. Presence of any active, uncontrolled systemic bacterial, viral or fungal infection requiring intravenous (IV) anti-infectives, including clinically significant viral infection or uncontrolled viral reactivation of Epstein-Barr virus, Cytomegalovirus, Adenovirus, BK-virus, or Human herpesvirus 6. If treated with anti-infective agents, patients must be asymptomatic for \\>5 days prior to enrollment.\n6. History of any malignancy within 2 years with the exception of cured stage 1 cancers or CIS and potentially indolent cancers not requiring active treatment or controlled with hormone therapy. Discuss patients with indolent cancers with the medical monitor.\n7. History of hypersensitivity reactions to products containing murine proteins.\n8. Active CNS lymphoma.\n9. Evidence of acute graft versus host disease (aGVHD) \\> Grade 2 Mount Sinai Acute GVHD International Consortium (MAGIC) or chronic GVHD \\> mild (NIH) requiring ongoing systemic steroids and\u002For multiagent therapy.\n10. Patients who have received systemic immunosuppressive therapy for treatment of GVHD within 28 days of leukapheresis.\n11. Currently requiring systemic corticosteroid therapy (10 mg\u002Fday or less of prednisone or equivalent doses of other systemic steroids are allowed for control of non-exclusionary pre-existing conditions). A 2-week washout is required prior to leukapheresis and prior to lymphodepletion for patients on \\> 10 mg\u002Fday prednisone equivalent.\n12. Patients who have received donor lymphocyte infusions within 28 days of MB-105 infusion.\n13. Comorbidity that would impair the patient's ability to receive or tolerate MB-105 and\u002For affect participation in the study:\n\n    1. History of cardio- or cerebrovascular disease including myocardial infarction, unstable angina, or congestive heart failure (NYHA class III-IV) within 6 months or cerebrovascular accident (CVA; stroke) within 12 months prior to informed consent.\n    2. History of central nervous system (CNS) disorder(s) such as an uncontrolled seizure disorder, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.\n    3. Any serious underlying medical or psychiatric condition deemed by the investigator and medical monitor to be exclusionary due to risk to the patient or to protocol compliance.\n14. History of autoimmune disorders, including rheumatic diseases and thyroid disorders (though patients with a history of thyroid disease who have undergone successful therapy may be suitable). Exemptions for mild or limited disease may be granted after discussion between the Investigator and sponsor's medical monitor.\n15. Participated in active treatment on other interventional research clinical trials \\\u003C 30 days before enrollment (participation in follow-up permitted). Contact the medical monitor to discuss prior experimental agents targeting the T cell lineage and the appropriate washout period.\n16. Received bendamustine prior to enrollment (unless received an allo-HSCT in the interim).",{"count":205,"type":20},46,[24],"This is a single arm, two-stage, Phase 2, open-label, multicenter study of MB-105 in patients with CD5 Positive (CD5+) Relapsed \u002F Refractory T-cell Lymphoma (r\u002Fr TCL). This study will apply a Simon two-stage optimal design.",[29],[210],"MB-105-201","2025-09-30",{"date":213,"type":61},"2025-10-03",{"date":215,"type":61},"2025-02-15",{"date":217,"type":20},"2029-12",{"name":219,"class":68},"March Biosciences Inc",12,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":127},"100556856","phase-2-pi3k-inhibitors-for-the-treatment-of-relapsedrefractory-indolent-tnk-cell-lymphomas-100556856","NCT06530550","PI3K Inhibitors for the Treatment of Relapsed\u002FRefractory Indolent T\u002FNK-cell Lymphomas","Exploratory Clinical Study of PI3K Inhibitors in the Treatment of Relapsed\u002FRefractory Indolent T\u002FNK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial","Inclusion Criteria:\n\nthe proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).\n\nExclusion Criteria:\n\nHere is the translated text:\n\n1. Subjects who have previously used any PI3K inhibitors;\n2. Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and\u002For absorption of the study drug;\n3. Unable to discontinue medications that may prolong the QT interval (such as antiarrhythmic drugs) during the study period;\n4. Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);\n5. HBV or HCV infection (defined as HBsAg and\u002For HBcAb positive with HBV DNA copy number ≥ upper limit of normal reference value) or acute or chronic active hepatitis C (HCV) antibody positive;\n6. History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or history of allogeneic bone marrow or hematopoietic stem cell transplantation;\n7. Received autologous hematopoietic stem cell transplantation within 90 days before the first dose of study treatment;\n8. Presence of severe or uncontrolled cardiovascular disease;\n9. Presence of severe concomitant diseases that endanger patient safety or are deemed by the investigator to affect the completion of the study (e.g., uncontrolled hypertension, diabetes, thyroid disease);\n10. Pregnant or breastfeeding female patients, or baseline pregnancy test positive for women of childbearing potential;\n11. Diagnosed or treated for other malignancies within the past 5 years;\n12. Any other condition that the investigator deems unsuitable for participation in the study.",{"count":229,"type":20},51,[24],"Indolent T\u002FNK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T\u002FNK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T\u002FNK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed\u002Frefractory indolent T\u002FNK-cell lymphomas. Patients will be treated with Linperlisib or Duvelisib, with an expected overall response rate of 60% for PI3K inhibitor treatment.",[29,176,177],[185,234],"PI3K inhibitor","2025-08-11",{"date":237,"type":61},"2025-08-12",{"date":239,"type":61},"2024-08-10",{"date":241,"type":20},"2028-07-10",{"name":195,"class":126},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":250,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":21,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100569863","phase-1-phase-1-to-investigate-the-safety-tolerability-and-efficacy-of-gcc2005-in-patients-with-rr-nk-and-t-cell-malignancies-100569863","NCT06699771","Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R\u002FR NK and T-cell Malignancies","A Phase 1, Multicenter Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of GCC2005 With Lymphodepleting Chemotherapy in Treatment of Patients With Relapsed or Refractory NK and T-cell Malignancies","Inclusion Criteria:\n\n* Patients with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).\n* Patients with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment option considered as assessed by the Investigator.\n* According to the Lugano classification, patients having lesion\u002Fnodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0 cm for extranodal lesions, and the boundaries are clearly shown.\n* Patient has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.\n* Patients who satisfy the criteria defined in the protocol.\n* Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Has T-ALL\u002FT-LBL or CTCL.\n* Patient with CNS lymphoma or any involvement of the CNS.\n* Patient who had a prior history of another malignancy over the last 3 years.\n* Patients who have used hematopoietic growth factor therapy within 14 days prior to Screening.\n* Patients who have had prior CAR-T or CAR-NK therapies.\n* Presence of uncontrolled fungal, bacterial, viral infection or other infection requiring IV antimicrobials for management\n* Patients with previous allogenic organ transplantation\n* Patients with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency.\n* Patients with acute GvHD ≥ Grade 3 or extensive chronic GvHD within 2 weeks of lymphodepletion.\n* Patients with known active Hepatitis B or C\n* Patients with presence of Grade 2 or greater toxicity from the previous treatment.","19 Years","80 Years",{"count":172,"type":20},[23],"This is a Phase 1 (a and b), first in human (FIH), single-arm, open-label, multicenter study to evaluate the safety, tolerability and efficacy of GCC2005 in the treatment of patients with relapsed\u002Frefractory (R\u002FR) NK or T-cell malignancies who have received at least two prior lines of therapy.",[29],"2025-04-28",{"date":258,"type":61},"2025-04-30",{"date":260,"type":61},"2025-03-07",{"date":262,"type":20},"2027-08",{"name":264,"class":68},"GC Cell Corporation",3,{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":273,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":21,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":297},"100475887","phase-1-tagraxofusp-in-pediatric-patients-with-relapsed-or-refractory-cd123-expressing-hematologic-malignancies-100475887","NCT05476770","Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies","A Phase I Study of Tagraxofusp With or Without Chemotherapy in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies","Inclusion Criteria:\n\nAge\n\n* Patients must be ≥ 1 and ≤21 years of age at the time of study enrollment.\n\nDiagnosis\n\n* Relapsed and\u002For refractory hematologic malignancy (including, but not limited to, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, mixed phenotype acute leukemia, acute undifferentiated leukemia, blastic plasmacytoid dendritic cell neoplasm, Hodgkin lymphoma, and non-Hodgkin lymphoma).\n* Tumor cells must demonstrate surface expression of CD123 at the time of enrollment by flow cytometry or immunohistochemistry, as defined by the local institution.\n\nDisease Status:\n\nMonotherapy, Part 1\n\n* Second or greater relapse; or\n* Refractory after 2 or more chemotherapy cycles; or\n* First relapse after primary chemotherapy-refractory disease; or\n* BPDCN in first relapse or refractory after 1 or more chemotherapy cycles\n\nCombination therapy, Part 2\n\n* First or greater relapse; or\n* Refractory after 2 or more chemotherapy cycles; or\n* BPDCN in first relapse or refractory after 1 or more chemotherapy cycles\n\nFor relapsed\u002Frefractory leukemia, patients must have:\n\n* \\>5% blasts in the bone marrow aspirate or biopsy by morphology or flow cytometry\n* Patients with 1% - 5% blasts are eligible for Part 2, Cohort C (only), if A single bone marrow sample with flow cytometry and at least one other test (e.g. karyotype, FISH, PCR, or NGS) shows ≥ 1% leukemic blasts and\u002For flow cytometry demonstrates a stable or rising level of disease on two serial bone marrows.\n\nFor relapsed\u002Frefractory non-Hodgkin or Hodgkin lymphoma, patients must have:\n\n* Histologic verification of relapse\n* Measurable disease documented by radiographic criteria or bone marrow\n* Patients in Part 1 may have sites of non-CNS extramedullary disease, but no CNS disease. Patients in Part 2 may have CNS disease and\u002For other non-CNS extramedullary disease. No cranial irradiation is allowed during the protocol therapy.\n* Patients with Down syndrome are eligible to participate in Part 1 only.\n\nPerformance Level\n\n* Karnofsky \\> 50% for patients \\> 16 years of age and Lansky \\> 50% for patients ≤ 16 years of age (See Appendix I for Performance Scales). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\nPrior Therapy\n\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy, defined as resolution of all such toxicities to ≤ Grade 2 or lower per the inclusion\u002Fexclusion criteria.\n\nMyelosuppressive chemotherapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. At least 14 day must have elapsed since the completion of myelosuppressive therapy. However, individuals may receive any of the following medications within 14 days without a \"wash-out period\":\n\n* Hydroxyurea: Hydroxyurea can be initiated and\u002For continued for up to 24 hours prior to the start of protocol therapy.\n* \"Maintenance-style\" therapy: therapy including vincristine (dosed a maximum of one-time weekly), oral 6-mercaptopurine, oral methotrexate (dosed a maximum of one-time weekly), intrathecal therapy (dosed a maximum of one-time weekly) and\u002For dexamethasone (dosed at ≤3 mg\u002Fm2\u002Fdose twice daily) or prednisone (dosed at ≤20 mg\u002Fm2\u002Fdose twice daily) can be continued for up to 24 hours prior to entering the study.\n* Hematopoietic stem cell transplant: Patients who have experienced their relapse after a HSCT are eligible, provided they have no evidence of acute or chronic Graft-versus-Host Disease (GVHD) and are at least 100 days post-transplant at the time of enrollment.\n* Hematopoietic growth factors: It must have been at least 7 days since the completion of therapy with granulocyte colony stimulating factor (GCSF) or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta®).\n* Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.\n* Monoclonal antibodies: Maximum of 3 half-lives of the antibody or 21 days (whichever is shorter) must have elapsed after the last dose of monoclonal antibody.\n* Immunotherapy: At least 30 days from last infusion of chimeric antigen receptor T cell (CART) therapy or tumor vaccine.\n* Radiation Therapy (XRT):\n\n  1. ≥ 84 days must have passed, from the end of therapy, if patient received prior total body irradiation (TBI).\n  2. ≥ 42 days must have passed, from the end of therapy, if patient received craniospinal irradiation (CSI).\n  3. ≥ 14 days must have passed after whole brain radiotherapy or stereotactic radiation therapy.\n  4. No washout period is required for:\n\n  i. Extramedullary site other than CNS that is a maximum 10 x 10 cm total radiation non-CNS field. If the field is \\> 10 x 10 cm, a 14-day washout period is required. ii. Local ocular radiotherapy as long as subject has measurable\u002Fevaluable disease outside the radiation port.\n* Patients that have received other non-tagraxofusp CD123 targeting agents are eligible. Patients that have previously received tagraxofusp are not eligible.\n\nOrgan Function Requirements\n\nAdequate Bone Marrow Function Defined as:\n\n* Patients should not be known to be refractory to red blood cell or platelet transfusions.\n* Blood counts are not required to be normal prior to enrollment on trial. However, platelet count must be ≥20,000\u002Fmm3 to initiate therapy (may receive platelet transfusions).\n\nAdequate Renal Function Defined as:\n\n* Patient must have a calculated creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73m2 OR a normal serum creatinine based on age\u002Fgender in the chart below:\n\nMaximum Serum Creatinine (mg\u002FdL):\n\n* 1 to \\\u003C 2 years old - Male: 0.6, Female: 0.6\n* 2 to \\\u003C 6 years old - Male:0.8, Female: 0.8\n* 6 to \\\u003C 10 years old - Male: 1, Female: 1\n* 10 to \\\u003C 13 years old - Male: 1.2, Female: 1.2\n* 13 to \\\u003C 16 years old - Male: 1.5, Female: 1.4\n* ≥ 16 years old - Male: 1.7, Female: 1.4\n\nThe threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.\n\nAdequate Liver Function Defined as:\n\n* Total bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x institutional upper limit of normal for age\n* SGPT (ALT) and SGOT (AST) must be less than 3x institutional upper limit of normal.\n* Serum albumin ≥3.2 g\u002FdL (albumin infusion independent).\n\nAdequate Cardiac Function Defined as:\n\n* Shortening fraction of ≥27% by echocardiogram, or\n* Ejection fraction of ≥ 50% by gated radionuclide study\u002Fechocardiogram.\n\nAdequate Pulmonary Function Defined as:\n\n* Pulse oximetry \\> 94% on room air (\\> 90% if at high altitude)\n* No evidence of dyspnea at rest and no exercise intolerance.\n\nReproductive Function\n\n* Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.\n* Female patients with infants must agree not to breastfeed their infants while on this study.\n* Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for 12 weeks after the last dose of tagraxofusp.\n\nExclusion Criteria\n\nDisease Status:\n\n* Patients with CNS disease are not eligible for Part 1.\n* Patients with isolated CNS disease are not eligible for Part 1 or Part 2.\n* Patients with isolated non-CNS disease are eligible for Part 1 and Part 2.\n\nConcomitant Medications\n\n* Corticosteroids - Patients receiving corticosteroids for disease control who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible.\n* Investigational Drugs - Patients who are currently receiving another investigational drug are not eligible. The definition of \"investigational\" for use in this protocol means any drug that is not licensed by the FDA, Health Canada or the Therapeutic Goods Administration to be sold in the countries they govern. (United States, Canada and Australia)\n* Anti-cancer Agents - Patients who are currently receiving or may receive while on therapy, other anti-cancer agents, radiation therapy or immunotherapy are not eligible \\[with the exceptions being laid out in the inclusion criteria under 'Prior Therapy'\\]. Intrathecal chemotherapy (at the discretion of the primary oncologist) may be given up to one week prior to the initiation of study treatment (day 1 therapy).\n* Anti-GVHD or agents to prevent organ rejection post-transplant - Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. At least 4 weeks must have elapsed after the last dose of GVHD meds.\n\nInfection Criteria - Patients are excluded if they have:\n\n* Positive blood culture within 48 hours of study enrollment;\n* Fever above 38.2 within 48 hours of study enrollment with clinical signs of infection. Fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability.\n* A positive fungal culture within 30 days of study enrollment.\n* Active fungal, viral, bacterial, or protozoal infection requiring IV treatment. Chronic prophylaxis therapy to prevent infections is allowed.\n* Patients will be excluded if they have a known allergy to any of the drugs used in the study.\n* Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results.\n* Patients with DNA fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded.","1 Year","21 Years",{"count":276,"type":20},54,[23],"Tagraxofusp is a protein-drug conjugate consisting of a diphtheria toxin redirected to target CD123 has been approved for treatment in pediatric and adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). This trial aims to examine the safety of this novel agent in pediatric patients with relapsed\u002Frefractory hematologic malignancies.\n\nThe mechanism by which tagraxofusp kills cells is distinct from that of conventional chemotherapy. Tagraxofusp directly targets CD123 that is present on tumor cells, but is expressed at lower or levels or absent on normal hematopoietic stem cells. Tagraxofusp also utilizes a payload that is not cell cycle dependent, making it effective against both highly proliferative tumor cells and also quiescent tumor cells.\n\nThe rationale for clinical development of tagraxofusp for pediatric patients with hematologic malignancies is based on the ubiquitous and high expression of CD123 on many of these diseases, as well as the highly potent preclinical activity and robust clinical responsiveness in adults observed to date.\n\nThis trial includes two parts: a monotherapy phase and a combination chemotherapy phase. This design will provide further monotherapy safety data and confirm the FDA approved pediatric dose, as well as provide safety data when combined with chemotherapy.\n\nThe goal of this study is to improve survival rates in children and young adults with relapsed hematological malignancies, determine the recommended phase 2 dose (RP2D) of tagraxofusp given alone and in combination with chemotherapy, as well as to describe the toxicities, pharmacokinetics, and pharmacodynamic properties of tagraxofusp in pediatric patients.\n\nAbout 54 children and young adults will participate in this study. Patients with Down syndrome will be included in part 1 of the study.",[280,281,16,282,283,284,82,29,285,286,287],"Hematologic Malignancy","AML","BPDCN","MDS","Lymphoblastic Lymphoma","Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia","Acute Undifferentiated Leukemia","2024-12-04",{"date":290,"type":61},"2024-12-06",{"date":292,"type":61},"2022-11-11",{"date":294,"type":20},"2027-11-11",{"name":296,"class":126},"Therapeutic Advances in Childhood Leukemia Consortium",31,{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":21,"phases":307,"briefSummary":308,"conditions":309,"keywords":310,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":127},"100298146","phase-1-durvalumab-in-different-combinations-with-pralatrexate-romidepsin-and-oral-5-azacitidine-for-lymphoma-100298146","NCT03161223","Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma","Phase 1\u002F2a Study of Anti-PD-L1 Monoclonal Antibody Durvalumab in Combination With Pralatrexate and Romidepsin, Oral 5-Aza and Romidepsin, Romidepsin Alone, or Oral 5-Azacitidine for Treatment of Patients With Relapsed and Refractory PTCL","Inclusion Criteria (these criteria apply to both the phase 1 and phase 2 portion of the study)\n\n* Age \\>18 years at the time of signing the informed consent\n* Patients must have histologically confirmed newly diagnosed (ND) or Relapsed\u002FRefractory Peripheral T-Cell Lymphoma (R\u002FR PTCL) defined according to the 2016 World Health Organization (WHO) classification criteria.\n* Patients with R\u002FR PTCL who have received at least one previous line of therapy are eligible to be enrolled in this study.\n* Patients who are candidate for an autologous or allogeneic stem cell transplantation (SCT) will be allowed to receive the study drugs as a \"bridge\" to transplantation.\n* Evaluable (phase 1) or measurable (phase 2) disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Patients must have adequate organ and marrow function as defined by:\n\n  1. Aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2 x institutional upper limit of normal (ULN); total bilirubin ≤ 1.5 x ULN (AST, ALT, and total bilirubin ≤ 3 × ULN in subjects with documented Gilbert's syndrome or hyperbilirubinemia clearly attributed to lymphoma involvement of the liver);\n  2. Creatinine levels \\\u003C 2 mg\u002FdL; or creatinine clearance \\> 40 mL\u002Fmin\n  3. Absolute neutrophil count (ANC) \\> 1,000\u002FμL; platelet count \\> 75,000\u002FμL\n  4. Negative urine or serum pregnancy test for women of childbearing potential. All women of childbearing potential must agree to use an effective barrier method of contraception (either an intrauterine device (IUD) or double barrier method using condoms or a diaphragm plus spermicide) during the treatment period and for at least 1 month after discontinuation of the study drugs. Male subjects should use effective barrier method of contraception during the treatment period and for at least 3 months after discontinuation of the study drugs.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Ability to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria (these criteria apply to both the phase 1 and phase 2 portion of the study)\n\n* Prior Therapy (for patients with R\u002FR PTCL)\n\n  1. Exposure to any agent targeting PD-1, PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).\n  2. For three-drug combinations, the patient must not have been exposed to at least two of those drugs. For two drugs combinations patients must not have been exposed to any of those drugs. Patients will be enrolled in the first treatment Arm that satisfies this exclusion criterion, according to the following sequence: Arm A; Arm B; Arm C; Arm D.\n  3. Exposure to biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation therapy within 2 weeks prior to entering the study or lack of resolution of AE due to previously administered antineoplastic therapy to grade 1 or less according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.\n  4. Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10 mg\u002Fday of prednisone or equivalent for at least 5 days prior to the start of the study drugs.\n  5. Prior allogeneic SCT\n* History of, or suspected allergic reactions to, durvalumab, pralatrexate, oral 5-azacitidine, or romidepsin or any of their excipients.\n* For patients who are treated with oral 5-azacitidine, any gastrointestinal disorder that would interfere with the absorption of the study drug\n* Concomitant use of CYP3A4 inhibitors\n* Uncontrolled intercurrent illness.\n* Any of the following cardiac abnormalities (only for patients receiving romidepsin):\n\n  1. Congenital long QT syndrome;\n  2. corrected QT (QTc) interval ≥ 501 milliseconds;\n  3. Patients taking drugs leading to significant QT prolongation (See Appendix 3);\n  4. Myocardial infarction within 6 months of cycle 1, day 1. \\[Subjects with a history of myocardial infarction between 6 and 12 months prior to cycle 1, day 1, who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event, may participate\\];\n  5. Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats\u002Fmin);\n  6. Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;\n  7. An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥ 2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;\n  8. Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Appendix 5) and\u002For ejection fraction \\\u003C 40% by multitargeted acquisition (MUGA) scan or \\\u003C 50% by echocardiogram and\u002For magnetic resonance imaging (MRI);\n  9. A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);\n  10. Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes;\n  11. Uncontrolled hypertension, i.e., blood pressure (BP) of ≥ 160\u002F95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or\n  12. Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers).\n* Pregnancy or breast-feeding.\n* Active concurrent malignancy (except non-melanoma skin cancer, prostatic intraepithelial neoplasia, or carcinoma in situ of the cervix). Patients whose lymphoma has transformed from a less aggressive histology remain eligible.\n* Receipt of solid organ transplant.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[eg, colitis, Crohn's disease\\], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \\[granulomatosis with polyangiitis\\]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment.\n* Central nervous system (CNS) involvement, including lymphomatous meningitis.\n* Known active hepatitis A, B or C virus infection.\n* Known HIV infection.\n* History of primary immunodeficiency.\n* Receipt of live, attenuated vaccine within 30 days prior to study entry. Enrolled patients should not receive live vaccine during the study and 30 days after the last dose of durvalumab.",{"count":306,"type":20},148,[23,24],"This is an open-label, Phase 1\u002F2a, dose-finding study with an initial phase 1 portion, articulated in four separate treatment arms, followed by a dedicated phase 2 for qualifying treatment Arm(s).\n\nThe primary objective of the Phase 1 portion is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of: Durvalumab, oral 5-azacitidine, and romidepsin (Arm A); durvalumab, pralatrexate, and romidepsin (Arm B); durvalumab and romidepsin (Arm C); or durvalumab and oral 5-azacitidine (Arm D), in patients with peripheral T-cell lymphoma (PTCL). The safety and toxicity profile of these combinations will be evaluated throughout the entire study.\n\nIf one or more of the combinations in Arms A, B, C, or D are found to be feasible and an MTD is established, the phase 2 portion of the study will be initiated for the combination(s) with the strongest efficacy signal provided acceptable toxicity.",[29],[311,312,313,314],"Durvalumab","Pralatrexate","Romidepsin","5-Azacitidine","2022-03-16",{"date":317,"type":61},"2022-03-31",{"date":319,"type":61},"2018-05-30",{"date":321,"type":20},"2023-02",{"name":323,"class":126},"University of Virginia"]