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

February 3, 2020 updated by: The First Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

212

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The Fisrt Affiliated Hospital of Soochow University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Aining Sun, M.D., Ph.D.
        • Sub-Investigator:
          • Huiying Qiu, M.D., Ph.D.
        • Sub-Investigator:
          • Xiaowen Tang, M.D., Ph.D.
        • Sub-Investigator:
          • Yue Han, M.D., Ph.D.
        • Sub-Investigator:
          • Zhengming Jin, M.D.
        • Sub-Investigator:
          • Chengcheng Fu, M.D., Ph.D.
        • Sub-Investigator:
          • Feng Chen, M.D., Ph.D.
        • Sub-Investigator:
          • Xiao Ma, M.D., Ph.D.
        • Sub-Investigator:
          • Suning Chen, M.D., Ph.D.
        • Sub-Investigator:
          • Shengli Xue, M.D., Ph.D.
        • Sub-Investigator:
          • Xiang Zhang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: auto
patients receive autologous SCT
Procedure: HSCT
Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.
Active Comparator: haplo
patients receive haplo-SCT
Procedure: HSCT
Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leukemia-Free Survival
Time Frame: Five years
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.
Five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Five years
Defined as the survival duration starting at the day of graft infusion, terminating at the day of death or the end of follow-up.
Five years
Cumulative relapse incidence
Time Frame: Five years
Defined as the cumulative incidence of morphological relapse after the day of graft infusion.
Five years
Non-relapse Mortality
Time Frame: Five years
Defined as the cumulative incidence of death without cause of disease recurrence, which include the cause of GVHD, infection, hemorrhage, organic function failure, etc.
Five years
Cumulative incidence of engraftment
Time Frame: 180 days
Defined as the cumulative incidence of durable complete donor chimerism detected by STR-PCR.
180 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: Five years
Including incidence and severity of acute and chronic GVHD, activity of daily living, psychological status, recovery of professional activity, social adaption, etc.
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

European Society for Blood and Marrow Transplantation

Investigators

  • Principal Investigator: Depei Wu, M.D., Ph.D., The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZ3702
  • ChiCTR-TRC-14004196 (Registry Identifier: Chinese Clinical Trial Registry (ChiCTR))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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