Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT05084027
Status:
UNKNOWN
Last Update Posted:
2021-10-27
First Post:
2021-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease free survival', 'timeFrame': '2 year', 'description': '2-year DFS'}], 'secondaryOutcomes': [{'measure': 'incidence of toxic reaction', 'timeFrame': '2 year', 'description': '2-year incidence of toxic reaction'}, {'measure': 'overall survival', 'timeFrame': '2 year', 'description': '2-year OS'}, {'measure': 'cumulative incidence of relapse', 'timeFrame': '2 year', 'description': '2-year incidence of relapse'}, {'measure': 'incidence of acute and or chronic graft verus host disease', 'timeFrame': '2 year', 'description': '2-year incidence of cGVHD'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematologic Malignancy', 'Older Patients', 'Allogeneic Hematopoietic Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation for older patients with hematologic malignancies', 'detailedDescription': 'It was a phase Ⅱ clinical trial of new designed reduced-intensity conditioning regimen for older patients accepting allogeneic hematopoietic stem cell transplantation treatment. The regimen consisted of venetoclax combining with fludarabine and melphalan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age older than 50 years\n2. Patients diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome according to WHO diagnostic criteria.\n3. Patients who achieved complete remission before transplantation.\n4. Patients who have alternative donors and plane to accept allogeneic hematopoietic stem cell transplantation treatment.\n5. ECOG body status score 0-2.\n6. Good organ function level: ANC (neutrophil absolute value \\>=1.0x10\\^9/L; PLT \\>=30x10\\^9/L; HB \\>=80g/L; Tibil \\<=1.5 ULN; ALT / AST \\<=2.5 ULN; bun / Cr \\<=1.5 ULN; LVEF \\>=50%).\n7. Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing.\n\nExclusion Criteria:\n\n1. Patients who didn't achieved complete remission before transplantation (bone marrow smear: proportion of primordial cells \\>=5%) or any extramedullary recurrence.\n2. Patients who were previously known to be resistant to venetoclax.\n3. In patients with severe pulmonary insufficiency (obstructive and / or restrictive ventilation disorders), the researchers evaluated the patients who could not tolerate the super pretreatment scheme.\n4. Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of super pretreatment.\n5. In patients with severe renal insufficiency, the renal function index (CR) is more than 2 times of the upper limit of the normal value (ULN), or the 24-hour creatinine clearance rate (CR) is less than 50ml / min, the researchers evaluated that they could not tolerate the super pretreatment scheme.\n6. In patients with severe active infection, the researchers evaluated that they could not tolerate the pretreatment.\n7. Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study.\n8. Other reasons why the researchers could not be selected."}, 'identificationModule': {'nctId': 'NCT05084027', 'briefTitle': 'Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen Prior to Allogeneic Hematopoietic Stem Cell Transplantation for Older Patients With Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'ZJU-HSCT-RIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'description': 'older patients accepting venetoclax combining with fludarabine and melphalan as conditioning regimen prior to allogeneic hematopoietic stem cell transplantation treatment', 'interventionNames': ['Combination Product: venetoclax combining with fludarabine and melphalan']}], 'interventions': [{'name': 'venetoclax combining with fludarabine and melphalan', 'type': 'COMBINATION_PRODUCT', 'description': 'Venetoclax 400mg/day，oral，day-8～day-2; Fludarabine, 30mg/m2/day，intravenous，d-7～d-3；Melphalan, 140mg/ m2/d，intravenous，day-2', 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Luo, M.D.', 'role': 'CONTACT', 'email': 'luoyijr@163.com', 'phone': '+86057187233801'}], 'facility': 'The first Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Baodong Ye, MD', 'role': 'CONTACT', 'email': '13588453501@qq.com', 'phone': '+8657187236706'}], 'facility': 'First Affiliated Hospital of Zhejiang Chinese Medicine University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Xu, MD', 'role': 'CONTACT', 'email': 'zjuyujian@126.com', 'phone': '+8657187236706'}], 'facility': 'Second Affiliated Hospital of Zhejiang University, School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haowen Xiao, MD', 'role': 'CONTACT', 'email': 'xiaohaowen@zju.edu.cn', 'phone': '+86057187236706'}], 'facility': 'Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianping Lan, MD', 'role': 'CONTACT', 'email': 'lanjp@163.com', 'phone': '+8657187236706'}], 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Ningbo', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guifang Ouyang, MD', 'role': 'CONTACT', 'email': 'luoyijr@163.com', 'phone': '+86057187233801'}], 'facility': 'Ningbo Hospital of Zhejiang University', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Ningbo', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Lu, MD', 'role': 'CONTACT', 'email': 'luying741107@qq.com', 'phone': '+86057187236706'}], 'facility': "The Affiliated People's Hospital of Ningbo University", 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Wenzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Chen, MD', 'role': 'CONTACT', 'email': 'chenyi19527@163.com', 'phone': '+8657187236706'}], 'facility': 'The First Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Yi Luo, M.D.', 'role': 'CONTACT', 'email': 'luoyijr@163.com', 'phone': '+86057187233801'}, {'name': 'Yibo Wu, M.D.', 'role': 'CONTACT', 'email': 'wuyibo7@126.com', 'phone': '+8619858876273'}], 'overallOfficials': [{'name': 'Yi Luo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affilaated Hospital of Medical School of Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': "Zhejiang Provincial People's Hospital", 'class': 'OTHER'}, {'name': "The Affiliated People's Hospital of Ningbo University", 'class': 'OTHER_GOV'}, {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Ningbo Hospital of Zhejiang University', 'class': 'UNKNOWN'}, {'name': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yi Luo', 'investigatorAffiliation': 'First Affiliated Hospital of Zhejiang University'}}}}