[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jonathan Brammer\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100620332","phase-2-ruxolitinib-maintenance-post-hematopoietic-stem-cell-transplant-t-cell-lymphoma-100620332",false,"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.","ALL","18 Years",{"count":19,"type":20},44,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31,32,33],"T-cell Lymphoma","Graft Versus Host Disease","Lymphoma, T-Cell","Peripheral T Cell Lymphoma","T-cell Prolymphocytic Leukemia","Cutaneous T Cell Lymphoma","Adult T-cell Leukemia\u002FLymphoma","Primary Cutaneous T-Cell Non-Hodgkin Lymphoma",[35,36,37,38],"stem cell transplant","graft versus host disease","lymphoma","leukemia","RECRUITING","2026-04-10",{"date":42,"type":43},"2026-04-15","ACTUAL",{"date":45,"type":43},"2026-02-12",{"date":47,"type":20},"2027-01-31",{"name":49,"class":50},"Jonathan Brammer","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100484742","phase-2-ruxolitinib-for-the-treatment-of-t-cell-large-granular-lymphocytic-leukemia-100484742","NCT05592015","Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia","A Phase II Study Evaluating the Efficacy of Ruxolitinib in Patients With T-Cell Large Granular Lymphocytic Leukemia (T-LGLL)","Inclusion Criteria:\n\n* Age 18 or older and able to swallow pills\n* Diagnosis of T-LGLL defined as: LGL cell population meeting diagnostic criteria (defined as CD3+CD8+ cell population \\>650\u002Fmm3 or CD3+CD8+CD57+ population \\>500\u002Fmm3 or LGL cell population with other immunophenotype that includes co-expression of CD3+, CD8+, CD57+ with \\>500 cells\u002Fmm3 and the presence of a clonal T-cell receptor (within 1 month of diagnosis or relapse). This also includes patients with rare T-LGLL variants include CD4+ T-LGLL, and gamma\u002Fdelta T-LGLL which can be CD4- and CD8-), though patients still must have the presence of a clonal T-cell receptor within 1 month of diagnosis or relapse. Note: patients with MDS-like T-LGLL may be included with PI approval even if CD3+CD8+ cell population is \\\u003C 650\u002Fmm\\^3, though +TCR is required. Natural-Killer (NK) LGL is also permitted, provided there is a clonal NK-cell population noted with \\> 500 cells\u002Fmm\\^3\n* Untreated T-LGLL or failed at least one line of frontline therapy;\n* Patients must be off treatment for at least 14 days or 5 half-lives, whichever is longer\n* Require Treatment for T-LGLL (one or more required)\n\n  * Symptomatic anemia with hemoglobin \\\u003C 10 g\u002FdL\n  * Transfusion-dependent anemia\n  * Neutropenia with absolute neutrophil count (ANC) \\\u003C 500\u002Fmm\\^3\n  * Neutropenia with ANC \\\u003C 1500\u002Fmm\\^3 with recurrent infections\n* Platelet count \\> 50 x 10\\^9\u002FL. Platelet transfusion may be utilized to meet inclusion criteria, as long as the platelet count remains \\>50,000\u002FuL within 5 days of last transfusion. Note: Patients with platelets \\\u003C100 x 109\u002FL and renal impairment are not permitted to enroll to the study. Renal impairment is defined as creatinine clearance (CrCl) \\\u003C 90 mL\u002Fmin.\n* Serum creatinine =\\\u003C 2 x the upper limit of normal (ULN)\n* \\- Estimated glomerular filtration rate (eGFR) =\\> 30 mL\u002Fmin using the Modification of Diet in Renal Disease (MDRD) equation (multiplying eGFR by each subjects Body Surface Area \\[BSA\\])\n* Total bilirubin =\\\u003C 1.5 x ULN (patients with Gilbert's syndrome with a bilirubin \\> 1.5 x ULN permitted)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Alkaline phosphatase (ALP) =\\\u003C 2.5 x ULN\n* Eastern cooperative oncology group (ECOG) performance status =\\\u003C 2\n* 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 treatment until 5 half-lives have passed. Male subject agrees to use an acceptable method for contraception for the duration of the study treatment until 5 half-lives have passed.\n* Able to sign informed consent\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) less than 100\u002Fmm\\^3. Note: granulocyte colony-stimulating factor (G-CSF) may be utilized to enable patients to meet inclusion criteria, as long as the ANC remains above 100\u002Fmm\\^3 for 5 days after administration of last growth-factor.\n* Active infection requiring ongoing anti-microbial treatment. Patients with human immunodeficiency virus (HIV), positive hepatitis B surface antigen or hepatitis C antibody will be excluded. Patients with tuberculosis risk factors will be required to undergo quantiferon testing and\u002For purified protein derivative (PPD) testing with a negative result prior to entering the study.\n* Concurrent immune-suppressive therapy (prednisone or equivalent up to 20 mg permitted to treat LGLL symptoms, but must be weaned within one month of initiation of trial drug). Patients on stable, chronic prednisone =\\\u003C 10 mg for rheumatologic\u002Fautoimmune conditions are exempted from this requirement. They may enroll on the study\n* Active, concurrent malignancy unless deemed related to T-LGLL by principal investigator (PI). Early stage skin cancers, prostate cancer, permitted if under no active therapy\n* For females of childbearing potential: Positive pregnancy test or lactating\n* Unstable angina or myocardial infarction within the past 2 months\n* Chronic obstructive pulmonary disease or other interstitial lung disease in active exacerbation\n* Cirrhosis\n* For any strong CYP3A4 inhibitors deemed a moderate or severe risk of interaction with ruxolitinib, a wash-out period of 14 days, or 5 half-lives, whichever is longer, is needed prior to starting ruxolitinib\n* Given the CYP3A4 inhibition potential of grapefruit, grapefruit juice, Seville orange juice, pomelos, and starfruits, patients will need to refrain from these foods\u002Fdrinks for 14 days prior to initiation of therapy, and throughout the study period",{"count":60,"type":20},30,[23],"This phase II trial tests whether ruxolitinib works to shrink tumors in patients with T-cell large granular lymphocyte leukemia. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.",[64],"T-Cell Large Granular Lymphocyte Leukemia","2026-02-06",{"date":67,"type":43},"2026-02-10",{"date":69,"type":43},"2023-05-03",{"date":71,"type":20},"2026-07-31",{"name":49,"class":50},3,""]