Haplo HCT vs Haplo-cord HCT for Patients With AML
NCT03719534 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134
Last updated 2023-06-27
Summary
Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.
Conditions
- Hematopoietic Stem Cell Transplantation
- Haplo-identical Donor
- Cord Blood Unit
- Acute Myeloid Leukemia
Interventions
- PROCEDURE
-
haplo-HCT
HCT will be performed with a haploidentical donor
- PROCEDURE
-
haplo-cord HCT
Haploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit
Sponsors & Collaborators
-
Zhejiang University
collaborator OTHER -
The Second People's Hospital of Huai'an
collaborator OTHER -
Soochow Hopes Hematology Hospital
collaborator UNKNOWN -
Hygeia Suzhou Yongding Hospital
collaborator UNKNOWN -
The First Affiliated Hospital of Soochow University
lead OTHER
Principal Investigators
-
Depei Wu, M.D., Ph.D. · The First Affiliated Hospital of Soochow University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-01
- Primary Completion
- 2022-12-31
- Completion
- 2023-03-31
Countries
- China
Study Locations
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