Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
| Registry | NCT03596892 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 122 (Estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University (Other); collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou First People's Hospital, Peking University People's Hospital, Zhujiang Hospital, Third Affiliated Hospital, Sun Yat-Sen University |
| Conditions | Allogeneic Hematopoietic Stem Cell Transplantation, Conditions, Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia |
| Interventions | Decitabine, Busulfan (BU), Cyclophosphamide (CY) (Drug) |
| Dates | start 2018-07-01 (estimated), primary completion 2021-06-01 (estimated), completion 2022-06-01 (estimated), first posted 2018-07-24, last updated 2018-07-24 |
| Locations | 1 site in China |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Decitabine + BUCY | Experimental | Drug: Decitabine; Drug: Busulfan (BU); Drug: Cyclophosphamide (CY) | For MLL+ acute leukemia undergoing allo-HSCT，Decitabine+BUCY conditioning regimen was Decitabine 20mg/m2/day on days -14 and -10； Busulfan (BU) 3.2 mg/kg/day on days -7 and -4；Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2. |
| BUCY | Active comparator | Drug: Busulfan (BU); Drug: Cyclophosphamide (CY) | For MLL+ acute leukemia undergoing allo-HSCT，BUCY conditioning regimen was Busulfan (BU) 3.2 mg/kg/day on days -7 and -4；Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2. |
Sex: All, ages: 14 Years to 65 Years
Inclusion Criteria: * MLL+ acute leukemia undergoing allo-HSCT * 14-65 years Exclusion Criteria: * Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University | Guangzhou, Guangdong | China | Recruiting |