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Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03530085
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : December 22, 2020
Sponsor:
Collaborators:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou First People's Hospital
Peking University People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Zhujiang Hospital
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) is reported to be able to improve the outcomes for elderly acute myeloid leukemia (AML) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. In this prospective study, the safety and efficacy of Dec+Flu+Bu myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Allogeneic Hematopoietic Stem Cell Transplantation Conditioning Elderly Drug: Decitabine Drug: Busulfan (BU) Drug: Fludarabine(Flu) Phase 2 Phase 3

Detailed Description:
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is reported to be able to improve the outcomes for elderly AML(older than 60 years) in complete remission (CR). At present, the best conditioning regimen for elderly AML in CR remains in discussion. Flu+Bu conditioning regimen is the most commonly used regimen for elderly AML in CR 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 study, the safety and efficacy of Decitabine+ Fludarabine+Busulfan myeloablative conditioning regimens in patients with elderly AML in CR undergoing allo-HSCT are evaluated.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Decitabine+ Fludarabine+Busulfan Conditioning Regimen for Elderly Acute Myeloid Leukemia in Complete Remission Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Leukemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dec+Flu+Bu Conditioning Regimen
For AML patients older than 60 years in CR, Decitabine+ Fludarabine+Busulfan conditioning regimen was used (Decitabine 20mg/m2/day on days -9 to -7；Fludarabine(Flu) 30mg/m2/day on days -6 to -3；Busulfan (BU) 3.2 mg/kg/day on days -5 to -4).
 Drug: Decitabine
Decitabine was administered at 20mg/m2/day on days -9 to -7.

Drug: Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.

Drug: Fludarabine(Flu)
Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.


Outcome Measures
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Primary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 2 year ]

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

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AML patients older than 60 years, younger than 80 years
  • In complete remission before transplantation
  • With HLA-matched sibling donors

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): NCT03530085


Contacts
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Contact: Li Xuan 008615521251270 356135708@qq.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Li Xuan    +86-020-62787883    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
Third Affiliated Hospital, Sun Yat-Sen University
Zhujiang Hospital
Investigators
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Principal Investigator: Qifa Liu Department of Hematology,Nanfang Hospital
More Information
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Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03530085    
Other Study ID Numbers: Dec+FB-Elderly AML-2018
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Fludarabine
Busulfan
Decitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Alkylating Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists
Enzyme Inhibitors