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

Primary Purpose

Myelodysplastic Syndrome, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Granulocyte Colony-Stimulating Factor(G-CSF)
Decitabine (DAC)
Busulfan
Fludarabine (FLU)
Cyclophosphamide (CY)
Busulfan (BU)
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Hematology,Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

G-CSF+DAC+BF

G-CSF+DAC+BUCY

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Non-relapse mortality (NRM)

Secondary Outcome Measures

Overall survival (OS)
Disease-free survival (DFS)
Cumulative incidence of relapse
Adverse effects

Full Information

First Posted
July 5, 2022
Last Updated
March 20, 2023
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Peking University People's Hospital, Institute of Hematology & Blood Diseases Hospital, China, 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
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1. Study Identification

Unique Protocol Identification Number
NCT05453552
Brief Title
G-CSF+DAC+BUCY vs G-CSF+DAC+BF Conditioning Regimen for High-risk MDS Undergoing Allo-HSCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Peking University People's Hospital, Institute of Hematology & Blood Diseases Hospital, China, 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
G-CSF+DAC+BF
Arm Type
Experimental
Arm Description
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.
Arm Title
G-CSF+DAC+BUCY
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Granulocyte Colony-Stimulating Factor(G-CSF)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Decitabine (DAC)
Intervention Description
Decitabine was administered at 20mg/m2/day on days -14 to -10.
Intervention Type
Drug
Intervention Name(s)
Busulfan
Intervention Description
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group.
Intervention Type
Drug
Intervention Name(s)
Fludarabine (FLU)
Intervention Description
Fludarabine was administered at 30 mg/m2/day on days -7 to -3.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide (CY)
Intervention Description
Cyclophosphamide was administered at 60 mg/kg/day on days -3,-2.
Intervention Type
Drug
Intervention Name(s)
Busulfan (BU)
Intervention Description
Busulfan was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group.
Primary Outcome Measure Information:
Title
Non-relapse mortality (NRM)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
1 year
Title
Disease-free survival (DFS)
Time Frame
1 year
Title
Cumulative incidence of relapse
Time Frame
1 year
Title
Adverse effects
Time Frame
within 100 days post-transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Xuan
Phone
+86-020-62787883
Email
356135708@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qifa Liu
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology,Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Xuan
Phone
15521251270
Email
356135708@qq.com

12. IPD Sharing Statement

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

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