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

Primary Purpose

Acute Myeloid Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Decitabine
Busulfan (BU)
Fludarabine(Flu)
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Hematology,Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dec+Flu+Bu Conditioning Regimen

Arm Description

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).

Outcomes

Primary Outcome Measures

overall survival (OS)

Secondary Outcome Measures

disease-free survival (DFS)
relapse
transplant-related mortality (TRM)

Full Information

First Posted
May 8, 2018
Last Updated
December 18, 2020
Sponsor
Nanfang Hospital, Southern Medical University
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
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1. Study Identification

Unique Protocol Identification Number
NCT03530085
Brief Title
Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT
Official Title
Decitabine+ Fludarabine+Busulfan Conditioning Regimen for Elderly Acute Myeloid Leukemia in Complete Remission Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation, Conditioning, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dec+Flu+Bu Conditioning Regimen
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Decitabine
Intervention Description
Decitabine was administered at 20mg/m2/day on days -9 to -7.
Intervention Type
Drug
Intervention Name(s)
Busulfan (BU)
Intervention Description
Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.
Intervention Type
Drug
Intervention Name(s)
Fludarabine(Flu)
Intervention Description
Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.
Primary Outcome Measure Information:
Title
overall survival (OS)
Time Frame
2 year
Secondary Outcome Measure Information:
Title
disease-free survival (DFS)
Time Frame
2 year
Title
relapse
Time Frame
2 year
Title
transplant-related mortality (TRM)
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Xuan
Phone
008615521251270
Email
356135708@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qifa Liu
Organizational Affiliation
Department of Hematology,Nanfang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology,Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Xuan
Phone
+86-020-62787883
Email
356135708@qq.com
First Name & Middle Initial & Last Name & Degree
Qifa Liu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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