G-CSF+Decitabine+BUCY vs BUCY Conditioning Regimen for RAEB-1, REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT
Study Details
Study Description
Brief Summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure refractory anemia with excess blasts-1 (RAEB-1), refractory anemia with excess blasts-2 (RAEB-2) and acute myeloid leukemia (AML) secondary to myelodysplastic syndrome (MDS). At present, the best conditioning regimen for RAEB-1, RAEB-2 and AML secondary to MDS undergoing allo-HSCT remains in discussion. In this prospective randomized controlled study, the safety and efficacy of G-CSF+ Decitabine + BUCY and BUCY myeloablative conditioning regimens in patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT are evaluated.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2/Phase 3 |
Detailed Description
Allo-HSCT appears to be an efficient tool to cure patients with MDS and AML secondary to MDS. At present, the best conditioning regimen for MDS and AML secondary to MDS undergoing allo-HSCT remains in discussion. BUCY conditioning regimen is the standard myeloablative regimen for MDS and AML secondary to MDS undergoing allo-HSCT. However, it appears to have higher relapse rate. To reduce the relapse rate, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of G-CSF + Decitabine + BUCY and BUCY myeloablative conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT are evaluated.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: G-CSF + Decitabine + BUCY For patients with RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT ,Granulocyte Colony-Stimulating Factor(G-CSF)+Decitabine+BUCY conditioning regimen was G-CSF 5-10ug/kg/day on days -17 and -10 (when white blood cell is more than 20G/L, stop using G-CSF);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. |
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.
Drug: Granulocyte Colony-Stimulating Factor(G-CSF)
G-CSF was administered at 5-10 ug/kg/day on days -17 and -10. When white blood cell is more than 20G/L, stop using G-CSF.
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Active Comparator: BUCY For patients with RAEB-1, REAB-2 and AML Secondary to MDS 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. |
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.
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Outcome Measures
Primary Outcome Measures
- relapse rate [2 year]
Secondary Outcome Measures
- overall survival (OS) [2 year]
- disease-free survival (DFS) [2 year]
- transplant-related mortality (TRM) [2 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT
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14-65 years
Exclusion Criteria:
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Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
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Patients with any conditions not suitable for the trial (investigators' decision)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Department of Hematology,Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | China | 510515 |
Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Institute of Hematology and Blood Diseases Hospital
- Peking University People's Hospital
- First People's Hospital of Chenzhou
- Liuzhou Workers Hospital
Investigators
- Principal Investigator: Qifa Liu, Nanfang Hospital of Southern Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- G-CSF+Dec+BUCYvsBUCY-MDS-2016