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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myelodysplastic Syndrome; Allogeneic Hematopoietic Stem Cell Transplantation; Conditioning
• Intervention / Treatment: Drug: Cyclophosphamide (CY); Drug: Granulocyte Colony-Stimulating Factor(G-CSF); Drug: Decitabine (DAC); Drug: Fludarabine (FLU); Drug: Busulfan (BU)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 242
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Department of Hematology,Nanfang Hospital, Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: G-CSF+DAC+BF; For patients with RAEB-1, REAB-2 and AML Secondary to 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 -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 .
ACTIVE_COMPARATOR: G-CSF+DAC+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 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 to -2.	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 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 (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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Non-relapse mortality (NRM)	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	1 year
Disease-free survival (DFS)	1 year
Relapse rate	1 year

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Peking University People's Hospital; Guangzhou First People's Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Institute of Hematology & Blood Diseases Hospital; Third Affiliated Hospital, Sun Yat-Sen University; First People's Hospital of Chenzhou; First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 15, 2021
• Primary Completion (ANTICIPATED): July 31, 2023
• Study Completion (ANTICIPATED): July 31, 2024

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (ACTUAL): January 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Myelodysplastic Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Adjuvants, Immunologic; Cyclophosphamide; Decitabine; Lenograstim; Fludarabine; Busulfan
• Other Study ID Numbers: DAC+BUCY vs DAC+BF-MDS-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No