Trials / Completed
CompletedNCT03719534
Haplo HCT vs Haplo-cord HCT for Patients With AML
An Open-label, Multicenter, Randomized, Phase 3 Trial to Assess the Efficacy and Safety of Coinfusion With Unrelated Cord Blood Unit for Patients With Acute Myeloid Leukemia Undergoing Haploidentical Hematopoietic Cell Transplantation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- The First Affiliated Hospital of Soochow University · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-06-01
- Primary completion
- 2022-12-31
- Completion
- 2023-03-31
- First posted
- 2018-10-25
- Last updated
- 2023-06-27
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03719534. Inclusion in this directory is not an endorsement.