Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 11:37 PM
Study NCT ID:
NCT04677868
Status:
UNKNOWN
Last Update Posted:
2021-09-16
First Post:
2020-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MTX and Steroid for aGVHD Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2020-12-13', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety data', 'timeFrame': '1 year', 'description': 'Safety data'}], 'primaryOutcomes': [{'measure': 'Overall response rate (ORR) for GVHD treatment at 7 days after treatment', 'timeFrame': '7 days', 'description': 'Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response.'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR) at 28 days after treatment', 'timeFrame': '28 days', 'description': 'Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response.'}, {'measure': 'Relapse', 'timeFrame': '1 year', 'description': 'Relapse'}, {'measure': 'Non-relapse mortality', 'timeFrame': '1 year', 'description': 'Non-relapse mortality'}, {'measure': 'Overall survival', 'timeFrame': '1 year', 'description': 'Overall survival'}, {'measure': 'Disease free survival', 'timeFrame': '1 year', 'description': 'Disease free survival'}, {'measure': 'Failure free survival', 'timeFrame': '1 year', 'description': 'Failure free survival'}, {'measure': 'Chronic GVHD', 'timeFrame': '1 year', 'description': 'Chronic GVHD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute GVHD', 'MTX', 'Corticosteroid'], 'conditions': ['Acute GVH Disease']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to identify the efficacy and safety of methotrexate (MTX) combined corticosteroid treatment for acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).', 'detailedDescription': 'Allo-HSCT is an effective treatment of malignant hematopoietic diseases. However, aGVHD remains a major complication after allo-HSCT and the destruction of recipient tissues by alloantigen-activated T cells is a key event in the development of aGVHD. Corticosteroid is the standard first-line therapy for aGVHD due to their roles in suppressing T cell responses. However, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory GVHD were poor. Thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for aGVHD. The study hypothesis: MTX combined corticosteroid treatment could help to further ameliorate the activity of T cells and control aGVHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are fully informed and sign informed consent by themselves or their guardians;\n2. Patients receiving allogeneic hematopoietic stem cell transplantation;\n3. Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;\n4. Patients with stable implantation of granulocytes and platelets.\n\nExclusion Criteria:\n\n1. Patients who have received more than one transplant;\n2. Patients with overlap syndrome;\n3. Patients within six months after the failure of the first transplantation;\n4. Patients with uncontrollable active infection;\n5. Patients with recurrence of primary malignant hematopathy;\n6. Patients with DLI or induced graft-versus-host disease after first intervention;\n7. Patients with serious respiratory diseases;\n8. Patients with severe renal insufficiency;\n9. Patients with serious and uncontrolled heart disease;\n10. Patients with severe hepatobiliary diseases unrelated to graft-versus-host disease;\n11. Within one week patients who need to use more than 1mg/kg/d methylprednisolone for reasons other than graft-versus-host disease;\n12. patients who have participated in other clinical trials within 1 month;\n13. The researcher judges that there are other factors that are not suitable for participating'}, 'identificationModule': {'nctId': 'NCT04677868', 'briefTitle': 'MTX and Steroid for aGVHD Treatment', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Single-cohort, Phase II Study of Methotrexate Combined Corticosteroid in Chinese Patients With Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'MCSAG1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MTX and corticosteroid', 'description': 'Methylprednisolone 1 mg/kg/day MTX (10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II;', 'interventionNames': ['Drug: Methotrexate']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['Corticosteroid'], 'description': 'Methylprednisolone 1 mg/kg/day MTX (10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II;', 'armGroupLabels': ['MTX and corticosteroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao-Dong Mo', 'role': 'CONTACT', 'email': 'mxd453@163.com'}, {'name': 'Xiao-Jun Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University Institute of Hematology,Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiao-Dong Mo, Dr', 'role': 'CONTACT', 'email': 'mxd453@163.com', 'phone': '86-10-88326001'}], 'overallOfficials': [{'name': 'Xiao-Jun Huang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Xiao-Jun Huang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}