Haplo-PBSC+Cord vs Haplo-PBSC+BM for Hematological Malignancies Undergoing Allo-HSCT
NCT05290545 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314
Last updated 2024-08-13
Summary
The objective of this study was to explore whether the combination with umbilical cord blood (UCB) is associated with superior disease-free survival (DFS) in the setting of haploidentical donors (HID) transplantation.
Conditions
- Hematological Malignancies
- Hematopoietic Stem Cell Transplantation
Interventions
- OTHER
-
PBSCs
PBSCs harvest is performed from day 5 of G-CSF to obtain at least 7.0×10\^8 total nucleated cells/kg recipient ideal body weight.
- OTHER
-
Cord
The criteria for cord selection included the following: (1) ≥3 of 6 HLA loci , (2) blood type matches, (3) contained a minimum cell count of 0.3×10\^8 nucleated cells/kg and 0.15×10\^6 CD34-positive cells/kg before freezing. The third party UCB will be infused the day after infusion of PBSCs.
- OTHER
-
BMSCs
BMSCs of donor will be collected and infused at least 0.5×10\^8 total nucleated cells/kg recipient ideal body weight the day after PBSCs infusion.
Sponsors & Collaborators
-
First Affiliated Hospital of Guangxi Medical University
collaborator OTHER -
Hunan Provincial People's Hospital
collaborator OTHER -
The Seventh Affiliated Hospital of Sun Yat-sen University
collaborator OTHER -
First People's Hospital of Chenzhou
collaborator OTHER -
Dongguan People's Hospital
collaborator OTHER_GOV -
The First People's Hospital of Guangzhou
collaborator UNKNOWN -
Nanfang Hospital, Southern Medical University
lead OTHER
Principal Investigators
-
Qifa Liu · Nanfang Hospital, Southern Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-15
- Primary Completion
- 2023-01-02
- Completion
- 2024-03-30
Countries
- China
Study Locations
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