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

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT02744742
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other), Institute of Hematology and Blood Diseases Hospital (Other), Peking University People's Hospital (Other), First People's Hospital of Chenzhou (Other), Liuzhou Workers Hospital (Other)
202
1
2
65.4
3.1

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
  • Drug: Decitabine
  • Drug: Busulfan (BU)
  • Drug: Cyclophosphamide (CY)
  • Drug: Granulocyte Colony-Stimulating Factor(G-CSF)
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

Study Type:
Interventional
Actual Enrollment :
202 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Granulocyte Colony-stimulating Factor+Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Patients With RAEB-1, RAEB-2 and AML Secondary to MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Actual Study Start Date :
Apr 18, 2016
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. relapse rate [2 year]

Secondary Outcome Measures

  1. overall survival (OS) [2 year]

  2. disease-free survival (DFS) [2 year]

  3. transplant-related mortality (TRM) [2 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

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
  • 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.
Responsible Party:
Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT02744742
Other Study ID Numbers:
  • G-CSF+Dec+BUCYvsBUCY-MDS-2016
First Posted:
Apr 20, 2016
Last Update Posted:
Feb 14, 2022
Last Verified:
Apr 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2022