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

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ClinicalTrials.gov Identifier: NCT02744742
Recruitment Status : Unknown
Verified April 2016 by Qifa Liu, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : April 20, 2016
Last Update Posted : October 12, 2017
Sponsor:
Collaborators:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou First People's Hospital
Peking University People's Hospital
Zhujiang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Study Description
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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
Myelodysplastic Syndrome Allogeneic Hematopoietic Stem Cell Transplantation Conditioning 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 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
Study Start Date : April 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. relapse rate [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 2 year ]
  2. disease-free survival (DFS) [ Time Frame: 2 year ]
  3. transplant-related mortality (TRM) [ Time Frame: 2 year ]

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744742


Contacts
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Contact: Qifa Liu liuqifa628@163.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Li Xuan    +86-020-61641613    356135708@qq.com   
Principal Investigator: Qifa Liu         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou First People's Hospital
Peking University People's Hospital
Zhujiang Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University
More Information
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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: April 20, 2016    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Cyclophosphamide
Busulfan
Decitabine
Sargramostim
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors
Adjuvants, Immunologic