G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for RAEB-1,REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT

Myelodysplastic Syndrome Clinical Trial

Official title:

G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04713956
• Other study ID #: DAC+BUCY vs DAC+BF-MDS-2021
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 15, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Li Xuan
• Phone: +86-020-62787883
• Email: 356135708[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Allo-HSCT is the most effective way to cure 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. In this prospective study, the safety and efficacy of G-CSF+DAC+BUCY and G-CSF+DAC+BF conditioning regimens in RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT are evaluated.

Description:

Allo-HSCT is the most effective way to cure 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. Our previous study 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 including ours 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, we 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 RAEB-1, REAB-2 and AML secondary to MDS undergoing allo-HSCT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

• RAEB-1, REAB-2 and AML Secondary to MDS 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)

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Stem Cell Transplantation
• Conditioning
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes

Intervention

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.
• Decitabine (DAC)
Decitabine was administered at 20mg/m2/day on days -14 to -10.
• Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group, and it was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group .
• Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
• Fludarabine (FLU)
Fludarabine was administered at 30 mg/m2/day on days -7 to -3.

Locations

Country	Name	City	State
China	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	First Affiliated Hospital of Guangxi Medical University, First People's Hospital of Chenzhou, Guangzhou First People's Hospital, Institute of Hematology and Blood Diseases Hospital, Peking University People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-relapse mortality (NRM)		1 year
Secondary	Overall survival (OS)		1 year
Secondary	Disease-free survival (DFS)		1 year
Secondary	Relapse rate		1 year