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

NCT02744742 | Completed Phase 2 DMC

• 1 other identifier: G-CSF+Dec+BUCYvsBUCY-MDS-2016
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndrome; Allogeneic Hematopoietic Stem Cell Transplantation; Conditioning

Outcome Measures

Primary Outcomes (1)

• relapse rate

  2 year

Secondary Outcomes (3)

• overall survival (OS)

  2 year

• disease-free survival (DFS)

  2 year

• transplant-related mortality (TRM)

  2 year

Study Arms (2)

G-CSF + Decitabine + BUCY

EXPERIMENTAL

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

BUCY

ACTIVE COMPARATOR

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); Drug: Cyclophosphamide (CY)

Interventions

Decitabine DRUG

Decitabine was administered at 20mg/m2/day on days -14 and -10.

G-CSF + Decitabine + BUCY

Busulfan (BU) DRUG

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

BUCY; G-CSF + Decitabine + BUCY

Cyclophosphamide (CY) DRUG

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

BUCY; G-CSF + Decitabine + BUCY

Granulocyte Colony-Stimulating Factor(G-CSF) DRUG

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.

G-CSF + Decitabine + BUCY

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• RAEB-1, REAB-2 and AML Secondary to MDS undergoing allo-HSCT
• years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Institute of Hematology & Blood Diseases Hospital, China: collaborator
• Peking University People's Hospital: collaborator
• First People's Hospital of Chenzhou: collaborator
• Liuzhou Workers' Hospital: collaborator

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

• Xuan L, Dai M, Jiang E, Wang Y, Huang F, Fan Z, Xu N, Nie D, Liang X, Chen H, Ye J, Shi P, Liu H, Jin H, Lin R, Yan C, Zhang Y, Sun J, Han M, Liu Q. The effect of granulocyte-colony stimulating factor, decitabine, and busulfan-cyclophosphamide versus busulfan-cyclophosphamide conditioning on relapse in patients with myelodysplastic syndrome or secondary acute myeloid leukaemia evolving from myelodysplastic syndrome undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2023 Mar;10(3):e178-e190. doi: 10.1016/S2352-3026(22)00375-1. Epub 2023 Jan 23.

  PMID: 36702138 DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Decitabine; Busulfan; Cyclophosphamide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Qifa Liu

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 20, 2016
• Study Start: April 18, 2016
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2021
• Last Updated: February 14, 2022

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)