G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for High-risk MDS Undergoing Allo-HSCT

Myelodysplastic Syndrome Clinical Trial

Official title:

G-CSF+DAC+BUCY vs. G-CSF+DAC+BF Conditioning Regimen for Patients With High-risk MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05453552
• Other study ID #: NFEC-2022-233
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: July 2022
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

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

Locations

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

Sponsors (7)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	First People's Hospital of Chenzhou, Guangzhou First People's Hospital, Institute of Hematology & Blood Diseases Hospital, Peking University People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Seventh Affiliated Hospital of 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	Cumulative incidence of relapse		1 year
Secondary	Adverse effects		within 100 days post-transplantation