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Haplo-SCT vs ASCT With or Without Decitabine in AML CR1

Primary Purpose

Acute Myeloid Leukemia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HSCT
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, maintenance treatment, hematopoietic stem cell transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >= 18y
  • Diagnosed as AML (except acute promyelocytic leukemia M3) for the first time
  • Minimal Residual Disease (MRD) test can be achieved (molecular biology first if applicatable, and/or cytogenetics and/or immunophenotyping)
  • Presence of an available haplo-mismatch related donor

Exclusion Criteria:

  • Contra-indications of chemotherapy or hematopoietic stem cell transplantation
  • Presence of an available identical sibling donor or a 10/10 HLA loci-matched unrelated donor
  • Participating in other clinical trials concerning the prophylaxis of disease recurrence after ASCT
  • No effective contraception
  • Pregnant or lactating females
  • Other causes which are not suitable for the trial in investigator's consideration

Sites / Locations

  • The Fisrt Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

auto

haplo

Arm Description

patients receive autologous SCT

patients receive haplo-SCT

Outcomes

Primary Outcome Measures

Leukemia-Free Survival
Defined as the survival duration starting at the day of graft infusion, terminating at the day of death, morphological relapse or the end of follow-up.

Secondary Outcome Measures

Overall survival
Defined as the survival duration starting at the day of graft infusion, terminating at the day of death or the end of follow-up.
Cumulative relapse incidence
Defined as the cumulative incidence of morphological relapse after the day of graft infusion.
Non-relapse Mortality
Defined as the cumulative incidence of death without cause of disease recurrence, which include the cause of GVHD, infection, hemorrhage, organic function failure, etc.
Cumulative incidence of engraftment
Defined as the cumulative incidence of durable complete donor chimerism detected by STR-PCR.

Full Information

First Posted
February 10, 2014
Last Updated
February 3, 2020
Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
European Society for Blood and Marrow Transplantation
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1. Study Identification

Unique Protocol Identification Number
NCT02059720
Brief Title
Haplo-SCT vs ASCT With or Without Decitabine in AML CR1
Official Title
Haplo-mismatch Donor Stem Cell Transplantation (SCT) Versus Autologous SCT Followed or Not by Maintenance Therapy, for Patients With Acute Myeloid Leukemia (AML) in First Remission: A Chinese Randomized Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
Collaborators
European Society for Blood and Marrow Transplantation

4. Oversight

5. Study Description

Brief Summary
A multicentre, prospective, open-label clinical study, including a randomized controlled study in low or intermediate-risk group patients, and a cohort study of maintenance treatment with decitabine after ASCT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
acute myeloid leukemia, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, maintenance treatment, hematopoietic stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
auto
Arm Type
Active Comparator
Arm Description
patients receive autologous SCT
Arm Title
haplo
Arm Type
Active Comparator
Arm Description
patients receive haplo-SCT
Intervention Type
Procedure
Intervention Name(s)
HSCT
Intervention Description
Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.
Primary Outcome Measure Information:
Title
Leukemia-Free Survival
Description
Defined as the survival duration starting at the day of graft infusion, terminating at the day of death, morphological relapse or the end of follow-up.
Time Frame
Five years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Defined as the survival duration starting at the day of graft infusion, terminating at the day of death or the end of follow-up.
Time Frame
Five years
Title
Cumulative relapse incidence
Description
Defined as the cumulative incidence of morphological relapse after the day of graft infusion.
Time Frame
Five years
Title
Non-relapse Mortality
Description
Defined as the cumulative incidence of death without cause of disease recurrence, which include the cause of GVHD, infection, hemorrhage, organic function failure, etc.
Time Frame
Five years
Title
Cumulative incidence of engraftment
Description
Defined as the cumulative incidence of durable complete donor chimerism detected by STR-PCR.
Time Frame
180 days
Other Pre-specified Outcome Measures:
Title
Quality of Life
Description
Including incidence and severity of acute and chronic GVHD, activity of daily living, psychological status, recovery of professional activity, social adaption, etc.
Time Frame
Five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18y Diagnosed as AML (except acute promyelocytic leukemia M3) for the first time Minimal Residual Disease (MRD) test can be achieved (molecular biology first if applicatable, and/or cytogenetics and/or immunophenotyping) Presence of an available haplo-mismatch related donor Exclusion Criteria: Contra-indications of chemotherapy or hematopoietic stem cell transplantation Presence of an available identical sibling donor or a 10/10 HLA loci-matched unrelated donor Participating in other clinical trials concerning the prophylaxis of disease recurrence after ASCT No effective contraception Pregnant or lactating females Other causes which are not suitable for the trial in investigator's consideration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Depei Wu, M.D., Ph.D.
Phone
+86 512 67781856
Email
wudepei@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Chen, M.D.
Phone
+86 512 67781856
Email
chenjia@suda.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Depei Wu, M.D., Ph.D.
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fisrt Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Depei Wu, M.D., Ph.D.
Phone
+86 512 6778 1856
Email
wudepei@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Jia Chen, M.D.
Phone
+86 512 6778 1856
Email
chenjia@suda.edu.cn
First Name & Middle Initial & Last Name & Degree
Depei Wu, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Jia Chen, M.D.
First Name & Middle Initial & Last Name & Degree
Aining Sun, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Huiying Qiu, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Xiaowen Tang, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Yue Han, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Zhengming Jin, M.D.
First Name & Middle Initial & Last Name & Degree
Chengcheng Fu, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Feng Chen, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Xiao Ma, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Suning Chen, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Shengli Xue, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Xiang Zhang, M.D.

12. IPD Sharing Statement

Learn more about this trial

Haplo-SCT vs ASCT With or Without Decitabine in AML CR1

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