Trials / Not Yet Recruiting
Not Yet RecruitingNCT06133556
Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 237 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
This project is a prospective, multicenter, randomized controlled clinical study. The subjects were refractory / relapsed AML patients aged ≤ 60 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The classical Bu / Cy scheme or MCBC scheme was used for pretreatment. The primary endpoint of the study was the 3-year recurrence-free survival rate after allogeneic hematopoietic stem cell transplantation, and the secondary endpoints were 3-year overall survival rate, recurrence rate, treatment-related mortality, and pretreatment-related toxicity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MCBC regimen | using MCBC as conditioning regimen, Mel 60mg/ m2 -9\~-8d, Cladribine 5 mg/m2 -9\~-5d, Bu3.2mg/kg -5\~-3d； Cy 30mg/kg -2\~-1 d |
| DRUG | Bu/Cy regimen | control group, the standard conditioning regimen Busulfan/Cyclophosphamide |
Timeline
- Start date
- 2023-11-24
- Primary completion
- 2028-10-20
- Completion
- 2028-10-20
- First posted
- 2023-11-15
- Last updated
- 2023-11-15
Source: ClinicalTrials.gov record NCT06133556. Inclusion in this directory is not an endorsement.