Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-01 @ 5:51 PM
Study NCT ID:
NCT04838704
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2021-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ruxolitinib With Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2021-04-05', 'studyFirstSubmitQcDate': '2021-04-08', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '100-day cumulative II-IV aGVHD incidence after HSCT', 'timeFrame': 'From the date of transplantation to the first occurrence of grade II-IV acute GVHD, assessed up to 100 days.', 'description': 'Cumulative incidence of grade II-IV acute GVHD occurring within the first 100 days following transplantation.'}], 'secondaryOutcomes': [{'measure': 'Cumulative Incidence of Chronic GVHD', 'timeFrame': 'From the date of transplantation to the first diagnosis of chronic GVHD, assessed up to 3 years.', 'description': 'The cumulative incidence of chronic GVHD following transplantation.n'}, {'measure': 'Overall Survival', 'timeFrame': 'From the date of transplantation until death from any cause, assessed up to 3 years.', 'description': 'Overall survival following is defined as the time from transplantation to death from any cause.'}, {'measure': 'Adverse Events', 'timeFrame': 'From the date of transplantation to day 180 post-transplantation.', 'description': 'Incidence and type adverse events following transplantation.'}, {'measure': 'Cumulative Incidence of Relapse', 'timeFrame': 'From the date of transplantation to the first documented relapse, assessed up to 3 years.', 'description': 'Cumulative incidence of disease relapse following transplantation is defined as the time from transplantation to the first documented disease recurrence.'}, {'measure': 'GVHD-Free, Relapse-Free Survival', 'timeFrame': 'From the date of transplantation to the first occurrence of grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD, relapse, or death, assessed up to 3 years.', 'description': 'GVHD-free, relapse-free survival is defined as the time from transplantation to the first occurrence of grade III-IV acute GVHD, chronic GVHD requiring systemic therapy, disease relapse, or death from any cause.'}, {'measure': 'Non-Relapse Mortality', 'timeFrame': 'From the date of transplantation to death without prior relapse or disease progression, assessed up to 3 years.', 'description': 'Non-relapse mortality is defined as death without evidence of relapse or progression of the primary disease following transplantation.'}, {'measure': 'Relapse-Free Survival', 'timeFrame': 'From the date of transplantation to the first documented relapse or death from any cause, assessed up to 3 years.', 'description': 'Relapse-free survival is defined as the time from transplantation to the first documented relapse of the underlying disease or death from any cause.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Graft Versus Host Disease', 'ruxolitinib', 'HLA-haploidentical hematopoietic stem cell transplantation'], 'conditions': ['Graft Versus Host Disease']}, 'descriptionModule': {'briefSummary': 'Low Dose Ruxolitinib with Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor plus Methotrexate and Mycophenolate mofetil as Graft Versus Host Disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.', 'detailedDescription': 'The is a prospective, randomized two-arm, and multicenter study. To compare the efficacy and safety of low-dose ruxolitinib combined with calcineurin inhibitor and methotrexate vs. calcineurin inhibitor plus methotrexate and mycophenolate mofetil as graft versus host disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients must be diagnosed with malignant hematological disease.\n2. aged 12-70 years.\n3. Received HLA-haploidentical hematopoietic stem cell transplantation.\n4. received myeloablative conditioning\n5. Karnofsky score ≥70.\n6. creatinine clearance ≥60 mL/min (according to the Cockcroft-Gault formula). (7) liver and kidney function: aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of the normal range (ULN), total bilirubin ≤ 2 × ULN; serum creatinine ≤ 1.5 × ULN.\n\n8\\) left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography (ECHO). 9) life expectancy \\>12 weeks. 10) Voluntarily signed the consent form and could understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Active autoimmune disease, such as SLE, rheumatoid arthritis, etc.\n2. Current clinically significant active cardiovascular disease such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by New York Heart Association (NYHA) functional class, or a history of myocardial infarction within 6 months prior to enrollment.\n3. Other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes).\n4. human immunodeficiency virus (HIV) infection.\n5. cirrhosis of the liver, active hepatitis.\n6. Pregnant or lactating women.\n7. Patients who are concurrently enrolled in any clinical trials of similar drugs."}, 'identificationModule': {'nctId': 'NCT04838704', 'briefTitle': 'Ruxolitinib With Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Ruxolitinib With Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'RCMvsCM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RUX group', 'interventionNames': ['Drug: Ruxolitinib+Calcineurin inhibitor+Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Drug: Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil']}], 'interventions': [{'name': 'Ruxolitinib+Calcineurin inhibitor+Methotrexate', 'type': 'DRUG', 'description': 'low-dose ruxolitinib combine with calcineurin inhibitor and short course of methotrexate.', 'armGroupLabels': ['RUX group']}, {'name': 'Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil', 'type': 'DRUG', 'description': 'calcineurin inhibitor and short course of methotrexate and mycophenolate mofetil', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Hospital of Zhejiang Medical Colleage Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': "The Children's Hospital of Zhejiang University School of Medicine", 'class': 'OTHER'}, {'name': 'Yinzhou Hospital Affiliated to Medical School of Ningbo University', 'class': 'OTHER'}, {'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}