Trials / Unknown
UnknownNCT03596892
Decitabine+BUCY vs BUCY Conditioning Regimen for MLL+ Acute Leukemia Undergoing Allo-HSCT
Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 14 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.
Detailed description
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. BUCY conditioning regimen is the standard myeloablative regimen for MLL+ acute leukemia undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.
Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation
- Conditions
- Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Decitabine | Decitabine was administered at 20mg/m2/day on days -14 and -10. |
| DRUG | Busulfan (BU) | Busulfan was administered at 3.2 mg/kg/day on days -7 to -4. |
| DRUG | Cyclophosphamide (CY) | Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2. |
Timeline
- Start date
- 2018-07-01
- Primary completion
- 2021-06-01
- Completion
- 2022-06-01
- First posted
- 2018-07-24
- Last updated
- 2018-07-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03596892. Inclusion in this directory is not an endorsement.