[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07359859":3,"trial-entities:NCT07359859":175,"trial-summary:NCT07359859":179},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":57,"secondary_outcomes":62,"sex":67,"minimum_age":68,"maximum_age":15,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":89,"locations":92,"central_contacts":161,"overall_officials":168,"references":171,"see_also_links":172},"NCT07359859","25-212","A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant","Randomized Pilot Study of Ruxolitinib for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation After Intermediate-Dose Post-Transplant Cyclophosphamide (Rux Switch-Maintenance in Intermediate PTCY: RuSMa-PTCY) in Comparison to Full-Dose PTCY","RECRUITING","2029-01","2026-07","2026-07-07","2026-01-20","Memorial Sloan Kettering Cancer Center","OTHER",null,"The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).",[18],"Hematologic Malignancies",[20,21],"graft-versus-host disease (GVHD)","allogeneic hematopoietic stem cell transplant (allo-HCT)","INTERVENTIONAL","PREVENTION",[25],"PHASE2",{"count":27,"type":28},40,"ESTIMATED",[30,36,40,46,50,54],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Cyclophosphamide","An intermediate dose (medium dose) of Post-transplant Cyclophosphamide",[35],"An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib",{"type":31,"name":32,"description":37,"armGroupLabels":38},"A full dose of Post-transplant Cyclophosphamide",[39],"A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)",{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Mycophenolate Mofetil","Day +5 to +35",[39,35],[45],"MMF",{"type":31,"name":47,"description":48,"armGroupLabels":49},"Ruxolitinib","twice a day",[35],{"type":31,"name":51,"description":52,"armGroupLabels":53},"Tacrolimus","Day +5, taper per SoC",[39],{"type":31,"name":51,"description":55,"armGroupLabels":56},"Day +5, taper initiation within 2 weeks of starting Ruxolitinib",[35],[58],{"measure":59,"description":60,"timeFrame":61},"assess cGVHD-free survival","Chronic GVHD-free survival is defined as moderate-to-severe cGVHD requiring systemic immunosuppression treatment from the date of allo-HCT to first occurrence with follow-up through 12 months post-HCT or death.","1 year post-HCT",[63],{"measure":64,"description":65,"timeFrame":66},"incidence of grade 2-4 infections.","Grade 2-4 infections by CTCAE v5 either clinically or microbiologically will be assessed throughout the study until day +365. Causality and relationship with ruxolitinib will be determined.","1 year","ALL","18 Years",false,{"inclusion":71,"exclusion":78,"raw_text":88},[72,73,74,75,76,77],"Patients ≥18- years-old at time of consent","Diagnosis: hematologic malignancy in morphologic remission (blasts \\\u003C5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response","Donor: related or unrelated 7-8\u002F8 HLA-matched or related haploidentical","Karnofsky score ≥ 70%","Female subjects of childbearing potential (\\\u003C50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.","For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug",[79,80,81,82,83,84,85,86,87],"Recipient of CD34+ selected or engineered stem cell graft","Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)","Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.","Severely impaired renal function defined by serum creatinine \\> 2mg\u002FdL, renal dialysis requirement.","Use of investigational agent within 14 days pre-HCT","Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months","Uncontrolled psychiatric illness","Female patient who is pregnant or breastfeeding","Known allergy or sensitivity to ruxolitinib","Inclusion Criteria:\n\n* Patients ≥18- years-old at time of consent\n* Diagnosis: hematologic malignancy in morphologic remission (blasts \\\u003C5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response\n* Donor: related or unrelated 7-8\u002F8 HLA-matched or related haploidentical\n* Karnofsky score ≥ 70%\n* Female subjects of childbearing potential (\\\u003C50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.\n\n  °Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of the study drug. Effective birth control includes: \\*Intrauterine device (IUD) plus one barrier method \\*Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method \\*2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or \\* A vasectomized partner.\n* For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug\n\nExclusion Criteria:\n\n* Recipient of CD34+ selected or engineered stem cell graft\n* Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)\n* Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.\n* Severely impaired renal function defined by serum creatinine \\> 2mg\u002FdL, renal dialysis requirement.\n* Use of investigational agent within 14 days pre-HCT\n* Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months\n* Uncontrolled psychiatric illness\n* Female patient who is pregnant or breastfeeding\n* Known allergy or sensitivity to ruxolitinib",[90,91],"ADULT","OLDER_ADULT",[93,107,116,125,135,144,152],{"facility":94,"status":8,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":104},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[100],{"name":101,"role":102,"phone":103},"Doris Ponce, MD","CONTACT","646-608-3739",{"lat":105,"lon":106},40.70621,-74.54932,{"facility":108,"status":8,"city":109,"state":96,"zip":110,"country":98,"contacts":111,"geoPoint":113},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",[112],{"name":101,"role":102,"phone":103},{"lat":114,"lon":115},40.39428,-74.11709,{"facility":117,"status":8,"city":118,"state":96,"zip":119,"country":98,"contacts":120,"geoPoint":122},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",[121],{"name":101,"role":102,"phone":103},{"lat":123,"lon":124},41.04676,-74.02292,{"facility":126,"status":8,"city":127,"state":128,"zip":129,"country":98,"contacts":130,"geoPoint":132},"Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)","Commack","New York","11725",[131],{"name":101,"role":102,"phone":103},{"lat":133,"lon":134},40.84288,-73.29289,{"facility":136,"status":8,"city":137,"state":128,"zip":138,"country":98,"contacts":139,"geoPoint":141},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",[140],{"name":101,"role":102,"phone":103},{"lat":142,"lon":143},40.96899,-73.71263,{"facility":145,"status":8,"city":128,"state":128,"zip":146,"country":98,"contacts":147,"geoPoint":149},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",[148],{"name":101,"role":102,"phone":103},{"lat":150,"lon":151},40.71427,-74.00597,{"facility":153,"status":8,"city":154,"state":128,"zip":155,"country":98,"contacts":156,"geoPoint":158},"Memorial Sloan Kettering Nassau (Limited Protocol Activites)","Rockville Centre","11553",[157],{"name":101,"role":102,"phone":103},{"lat":159,"lon":160},40.65871,-73.64124,[162,165],{"name":163,"role":102,"phone":103,"email":164},"Doris Ponce, MD, MS","BMTTrials@mskcc.org",{"name":166,"role":102,"phone":167},"Brian Shaffer, MD","646-608-3737",[169],{"name":163,"affiliation":13,"role":170},"PRINCIPAL_INVESTIGATOR",[],[173],{"label":13,"url":174},"https:\u002F\u002Fwww.mskcc.org\u002F",{"nct_id":4,"conditions":176,"biomarkers":178},[177],"Malignant neoplasm of lymphoid, hematopoietic and\u002For related tissue",[],{"nct_id":4,"found":180,"summary":181,"prompt_version":191},true,{"design":182,"status":183,"heading":184,"summary":185,"follow_up":186,"word_count":187,"commitments":188,"compensation":189,"drugs_mentioned":190},"This interventional study aims to enroll 40 participants to compare two different approaches for preventing GVHD.","completed","Ruxolitinib for Preventing Graft-Versus-Host Disease After Stem Cell Transplant","This study is looking at whether the drug ruxolitinib, given with other medications like cyclophosphamide, mycophenolate mofetil, and tacrolimus, can help prevent graft-versus-host disease (GVHD) in people with blood cancers (hematologic malignancies) who are getting a stem cell transplant. GVHD is a serious complication where the transplanted cells attack the patient's body. Researchers want to see which approach is better at preventing chronic GVHD for up to one year after the transplant. You may be able to join if you are at least 18 years old and have a blood cancer that is in remission. The study aims to enroll 40 participants, but its current status is unclear.","Participants will be followed to assess cGVHD-free survival for one year after the stem cell transplant.",108,"Not specified in the trial record.","Not stated in the trial record.",[32,41,47,51],"v2"]