Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Myeloid Leukemia and Myelodysplastic Syndromes Undergoing Allo-HSCT
NCT05823714 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2023-04-21
Summary
The purpose of this prospective, open-label, single-center study is to evaluate the efficacy and safety of VEN-AZA (venetoclax and azacytidine) followed by modified BUCY (busulfan and cyclophosphamide) as conditioning regimen for high-risk myelodysplastic syndrome (MDS) and high-risk or relapsed/refractory acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
Interventions
- DRUG
-
VEN+AZA+Modified BUCY
Venetoclax: 200mg/day\*7days(It should be combined with triazole antifungal drugs). Azacytidine: 75mg/ m²/day\*7days.
Sponsors & Collaborators
-
The First Affiliated Hospital of Soochow University
lead OTHER
Principal Investigators
-
Depei Wu Wu, MD · The First Affiliated Hospital of Soochow University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 8 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-20
- Primary Completion
- 2025-01-20
- Completion
- 2026-01-20
Countries
- China
Study Locations
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