[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-cell-large-granular-lymphocyte-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-cell-large-granular-lymphocyte-leukemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100440031","phase-1-a-study-of-ruxolitinib-and-duvelisib-in-people-with-lymphoma-100440031",false,"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.","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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).",[26,27,28,29],"T-cell Lymphomas","NK-Cell Lymphomas","T-cell Prolymphocytic Leukemia","T-cell Large Granular Lymphocyte Leukemia",[31,32,33,34,35,29,28],"mature T-cell lymphomas","Ruxolitinib","Duvelisib","Relapsed or Refractory","21-176","RECRUITING","2026-04-06",{"date":39,"type":40},"2026-04-09","ACTUAL",{"date":42,"type":40},"2021-08-12",{"date":44,"type":20},"2027-08",{"name":46,"class":47},"Memorial Sloan Kettering Cancer Center","OTHER",9,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"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":57,"type":20},30,[59],"PHASE2","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.",[62],"T-Cell Large Granular Lymphocyte Leukemia","2026-02-06",{"date":65,"type":40},"2026-02-10",{"date":67,"type":40},"2023-05-03",{"date":69,"type":20},"2026-07-31",{"name":71,"class":47},"Jonathan Brammer",3]