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

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: Acute Myeloid Leukemia
• Intervention / Treatment: Procedure: HSCT

• Study Type: Interventional
• Enrollment (Anticipated): 212
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • The Fisrt Affiliated Hospital of Soochow University
      • Contact: Depei Wu, M.D., Ph.D.; Phone Number: +86 512 6778 1856; Email: wudepei@medmail.com.cn
      • Contact: Jia Chen, M.D.; Phone Number: +86 512 6778 1856; Email: chenjia@suda.edu.cn
      • 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	Defined as the cumulative incidence of morphological relapse after the day of graft infusion.	Five years
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.	Five years
Cumulative incidence of engraftment	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	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

• 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

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: hematopoietic stem cell transplantation; acute myeloid leukemia; allogeneic hematopoietic stem cell transplantation; maintenance treatment; autologous hematopoietic stem cell transplantation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: SZ3702; ChiCTR-TRC-14004196 (Registry Identifier: Chinese Clinical Trial Registry (ChiCTR))