[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07006506":3,"trial-entities:NCT07006506":173,"trial-summary:NCT07006506":177},{"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":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":17,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":79,"locations":82,"central_contacts":160,"overall_officials":166,"references":169,"see_also_links":170},"NCT07006506","25-033","A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant","Phase II Open Label Prospective Nonrandomized Trial of Belumosudil for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation","RECRUITING","2029-05-21","2026-06","2026-06-29","2025-05-21","Memorial Sloan Kettering Cancer Center","OTHER",true,"The purpose of this study is to find out whether adding belumosudil to a usual approach for reducing the risk of graft-versus-host disease (GVHD) may be an effective GVHD prevention approach for people with blood cancer who have a stem cell transplant. The investigators will also look at the safety of the study approach.",null,[19,20,21],"Graft Versus Host Disease","Graft Vs Host Disease","Hematologic Malignancy",[19,20,21,23,24,25,13,5],"Hematologic malignancy in morphologic remission","Belumosudil","Stem Cell Transplant","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},46,"ESTIMATED",[34],{"type":35,"name":24,"description":36,"armGroupLabels":37},"DRUG","Belumosudil is an oral selective inhibitor of Rho-GTPase-associated coiled-coil kinase 2 (ROCK2)",[38],"Participants with hematologic malignancy in morphologic remission",[40],{"measure":41,"description":42,"timeFrame":43},"Change in GVHD\u002Frelapse-free survival (GRFS) at 1-year post-Hematopoietic Cell Transplantation (HCT)","The primary objective is to assess the efficacy of belumosudil in the improvement of GRFS at 1-year post-HCT for patients receiving PTCY GVHD prophylaxis and separately for participants receiving CNI-based (CNI without PTCY) plus abatacept GVHD prophylaxis.","1 year",[],"ALL","18 Years",false,{"inclusion":49,"exclusion":64,"raw_text":78},[50,51,52,53,54,55,56,57,58,59,60,61,62,63],"Patients ≥ 18 years-old at time of consent.","Diagnosis: hematologic malignancy in morphologic remission who will be treated with RI or NMA conditioning and GVHD prophylaxis CNI-based (CNI without PTCY) plus abatacept or PTCY-based (CNI with PTCY).","Recipients of 7-8\u002F8 related or unrelated HLA-matched or related haploidentical donor.","Peripheral blood stem cell graft","Allo-HCT day \\\u003C120 at time of consent","Patient has received an allo-HCT transplant and is 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.","Patient has achieved engraftment. Engraftment is defined as ANC≥500\u002FμL and platelets ≥ 20000\u002FμL on 3 consecutive measurements (each occurring at least 1 day apart). The patient must not have had a platelet transfusion within 7 days before the first measurement.","Patient is ≥ 80 days and ≤ 20 days from allo-HCT infusion.","Karnofsky score ≥ 70%.","Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN)","Total bilirubin ≤1.5 x ULN (unless benign congenital hyperbilirubinemia).","Glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\u002F1.73 m2","Female subjects of childbearing potential (≤ 50 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.",[65,66,67,68,69,70,71,72,73,74,75,76,77],"Recipient of CD34+ selected or engineered stem cell graft.","Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin).","Evidence of current uncontrolled cardiovascular conditions, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.","Pulmonary dysfunction with DLCO \\\u003C50% corrected for hemoglobin","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.","Uncontrolled infection, including active hepatitis B and C. Definitive therapy for infection is required and must have no signs of progression within 7 days of the first day of study drug treatment.","Use of investigational agent within 14 days pre-HCT or anytime thereafter.","Active acute or chronic GVHD requiring systemic therapy (topical or local therapies are allowed).","Active treatment with corticosteroids at a dose of ≥ 0.25 mg\u002Fkg\u002Fday for non-GVHD indication.","Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year","Female patient who is pregnant or breastfeeding.","Prior therapy with belumosudil.","Known allergy or sensitivity to belumosudil or any other ROCK2 inhibitor.","Inclusion Criteria:\n\n* Patients ≥ 18 years-old at time of consent.\n* Diagnosis: hematologic malignancy in morphologic remission who will be treated with RI or NMA conditioning and GVHD prophylaxis CNI-based (CNI without PTCY) plus abatacept or PTCY-based (CNI with PTCY).\n* Recipients of 7-8\u002F8 related or unrelated HLA-matched or related haploidentical donor.\n* Peripheral blood stem cell graft\n* Allo-HCT day \\\u003C120 at time of consent\n\nPost-HCT inclusion criteria (within 3 weeks before start of belumosudil treatment)\n\n* Patient has received an allo-HCT transplant and is 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.\n* Patient has achieved engraftment. Engraftment is defined as ANC≥500\u002FμL and platelets ≥ 20000\u002FμL on 3 consecutive measurements (each occurring at least 1 day apart). The patient must not have had a platelet transfusion within 7 days before the first measurement.\n* Patient is ≥ 80 days and ≤ 20 days from allo-HCT infusion.\n* Karnofsky score ≥ 70%.\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN)\n* Total bilirubin ≤1.5 x ULN (unless benign congenital hyperbilirubinemia).\n* Glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\u002F1.73 m2\n* Female subjects of childbearing potential (≤ 50 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 study drug. Effective birth control includes: \\* Intrauterine device (IUD) plus one barrier method \\* Stable doses of hormonal contraception for at least 3 months (eg, 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* Evidence of current uncontrolled cardiovascular conditions, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.\n* Pulmonary dysfunction with DLCO \\\u003C50% corrected for hemoglobin\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\nPost-HCT exclusion criteria\n\n* Uncontrolled infection, including active hepatitis B and C. Definitive therapy for infection is required and must have no signs of progression within 7 days of the first day of study drug treatment.\n* Use of investigational agent within 14 days pre-HCT or anytime thereafter.\n* Active acute or chronic GVHD requiring systemic therapy (topical or local therapies are allowed).\n* Active treatment with corticosteroids at a dose of ≥ 0.25 mg\u002Fkg\u002Fday for non-GVHD indication.\n* Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year\n* Female patient who is pregnant or breastfeeding.\n* Prior therapy with belumosudil.\n* Known allergy or sensitivity to belumosudil or any other ROCK2 inhibitor.",[80,81],"ADULT","OLDER_ADULT",[83,97,106,115,125,134,144,151],{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":94},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[90],{"name":91,"role":92,"phone":93},"Doris Ponce, MD","CONTACT","646-608-3739",{"lat":95,"lon":96},40.70621,-74.54932,{"facility":98,"status":8,"city":99,"state":86,"zip":100,"country":88,"contacts":101,"geoPoint":103},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",[102],{"name":91,"role":92,"phone":93},{"lat":104,"lon":105},40.39428,-74.11709,{"facility":107,"status":8,"city":108,"state":86,"zip":109,"country":88,"contacts":110,"geoPoint":112},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",[111],{"name":91,"role":92,"phone":93},{"lat":113,"lon":114},41.04676,-74.02292,{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":88,"contacts":120,"geoPoint":122},"Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)","Commack","New York","11725",[121],{"name":91,"role":92,"phone":93},{"lat":123,"lon":124},40.84288,-73.29289,{"facility":126,"status":8,"city":127,"state":118,"zip":128,"country":88,"contacts":129,"geoPoint":131},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",[130],{"name":91,"role":92,"phone":93},{"lat":132,"lon":133},40.96899,-73.71263,{"facility":135,"status":8,"city":118,"state":118,"zip":136,"country":88,"contacts":137,"geoPoint":141},"New York University (Data Collection Only)","10010",[138],{"name":139,"role":92,"phone":140},"Jingmei Hsi, MD","646-501-4848",{"lat":142,"lon":143},40.71427,-74.00597,{"facility":145,"status":8,"city":118,"state":118,"zip":146,"country":88,"contacts":147,"geoPoint":150},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",[148],{"name":149,"role":92,"phone":93},"Doris M Ponce, MD",{"lat":142,"lon":143},{"facility":152,"status":8,"city":153,"state":118,"zip":154,"country":88,"contacts":155,"geoPoint":157},"Memorial Sloan Kettering Nassau (Limited Protocol Activites)","Rockville Centre","11553",[156],{"name":91,"role":92,"phone":93},{"lat":158,"lon":159},40.65871,-73.64124,[161,163],{"name":91,"role":92,"phone":93,"email":162},"ponced@mskcc.org",{"name":164,"role":92,"phone":165},"Gajan Raju, MD","646-608-3987",[167],{"name":91,"affiliation":13,"role":168},"PRINCIPAL_INVESTIGATOR",[],[171],{"label":13,"url":172},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":174,"biomarkers":176},[19,175],"Malignant neoplasm of lymphoid, hematopoietic and\u002For related tissue",[],{"nct_id":4,"found":15,"summary":178,"prompt_version":188},{"design":179,"status":180,"heading":181,"summary":182,"follow_up":183,"word_count":184,"commitments":185,"compensation":186,"drugs_mentioned":187},"This study plans to enroll 46 participants. It is an interventional study, meaning participants will receive a specific treatment.","completed","Belumosudil for Preventing Graft-Versus-Host Disease After Stem Cell Transplant","This study is looking at whether adding belumosudil, an oral medication, to the usual care can help prevent graft-versus-host disease (GVHD) in people with blood cancer who are having a stem cell transplant. GVHD is a serious complication where the new immune cells attack the patient's body. The study will also check the safety of this approach. You might be able to join if you are at least 18 years old, have a blood cancer that is in remission, and are having a stem cell transplant from a matched donor. The main goal is to see how many people are free from GVHD or cancer relapse one year after their transplant. The current recruitment status is unclear.","Participants will be followed for at least one year after their stem cell transplant to assess GVHD\u002Frelapse-free survival.",117,"Not specified in the trial record.","Not stated in the trial record.",[24],"v2"]