G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for High-risk MDS Undergoing Allo-HSCT
Study Details
Study Description
Brief Summary
Allo-HSCT is the most effective way to cure high-risk MDS patients. At present, the best conditioning regimen for high-risk MDS patients undergoing allo-HSCT remains in discussion. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in high-risk MDS patients undergoing allo-HSCT are evaluated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Allo-HSCT is the most effective way to cure high-risk MDS patients. At present, the best conditioning regimen for high-risk MDS patients undergoing allo-HSCT remains in discussion. A previous study by the investigators has showed that G-CSF +DAC+BUCY conditioning regimen could reduce the relapse and improve the survival compared with BUCY conditioning regimen, while the two conditioning regimens both have high non-relapse mortality (NRM). Several retrospective and prospective studies have demonstrated that BF conditioning regimen has a lower NRM compared with BUCY conditioning regimen, while the relapse and survival are similar in patients undergoing BF and BUCY conditioning regimens. Based on the above, the investigators design the prospective randomized controlled study to evaluate the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in high-risk MDS patients undergoing allo-HSCT.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: G-CSF+DAC+BF For patients with high-risk MDS undergoing allo- HSCT, Granulocyte Colony-Stimulating Factor (G-CSF)+Decitabine+BF conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -6 to -3, Fludarabine (FLU) 30mg/m2/ day on days -7 to -3. |
Drug: Granulocyte Colony-Stimulating Factor(G-CSF)
G-CSF was administered at 5 ug/kg/day on days-17 to -10. When white blood cell is more than 20G/L, stop using G-CSF.
Drug: Decitabine (DAC)
Decitabine was administered at 20mg/m2/day on days -14 to -10.
Drug: Fludarabine (FLU)
Fludarabine was administered at 30 mg/m2/day on days -7 to -3.
Drug: Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group.
|
| Active Comparator: G-CSF+DAC+BUCY For patients with high-risk MDS undergoing allo- HSCT, Granulocyte Colony -Stimulating Factor (G-CSF)+Decitabine+BUCY conditioning regimen was G-CSF 5ug/kg/day on days -17 to -10 (when white blood cell is more than 20G/L, stop using G-CSF), Decitabine 20mg/m2/day on days -14 to -10, Busulfan (BU) 3.2 mg/kg/day on days -7 to -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3, -2. |
Drug: Granulocyte Colony-Stimulating Factor(G-CSF)
G-CSF was administered at 5 ug/kg/day on days-17 to -10. When white blood cell is more than 20G/L, stop using G-CSF.
Drug: Decitabine (DAC)
Decitabine was administered at 20mg/m2/day on days -14 to -10.
Drug: Busulfan
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group.
Drug: Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3,-2.
|
Outcome Measures
Primary Outcome Measures
- Non-relapse mortality (NRM) [1 year]
Secondary Outcome Measures
- Overall survival (OS) [1 year]
- Disease-free survival (DFS) [1 year]
- Cumulative incidence of relapse [1 year]
- Adverse effects [within 100 days post-transplantation]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Had a diagnosis of RAEB-1 or RAEB-2 with IPSS-R >3
-
Age 18 to 65 years old
-
ECOG performance status of 0-2
-
HCT-CI of 0-2
-
Were willing to undergo allo-HSCT
Exclusion Criteria:
-
Therapy-related MDS
-
Previous allo-HSCT
-
Uncontrolled infections
-
Liver or renal dysfunction
-
Severe concomitant conditions not suitable for the trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Hematology,Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | China | 510515 |
Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
- Peking University People's Hospital
- Institute of Hematology and Blood Diseases Hospital
- Guangzhou First People's Hospital
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- First People's Hospital of Chenzhou
- The Seventh Affiliated Hospital of Sun Yat-sen University
Investigators
- Principal Investigator: Qifa Liu, Nanfang Hospital of Southern Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DAC-BUCY vs DAC-BF-HR MDS-2022