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

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ClinicalTrials.gov Identifier: NCT02059720
Recruitment Status : Recruiting
First Posted : February 11, 2014
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
European Group for Blood and Marrow Transplantation
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Procedure: HSCT Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Cumulative relapse incidence [ Time Frame: Five years ]
    Defined as the cumulative incidence of morphological relapse after the day of graft infusion.

  3. 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.

  4. Cumulative incidence of engraftment [ Time Frame: 180 days ]
    Defined as the cumulative incidence of durable complete donor chimerism detected by STR-PCR.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02059720


Contacts
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Contact: Depei Wu, M.D., Ph.D. +86 512 67781856 wudepei@medmail.com.cn
Contact: Jia Chen, M.D. +86 512 67781856 chenjia@suda.edu.cn

Locations
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China, Jiangsu
The Fisrt Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Depei Wu, M.D., Ph.D.    +86 512 6778 1856    wudepei@medmail.com.cn   
Contact: Jia Chen, M.D.    +86 512 6778 1856    chenjia@suda.edu.cn   
Principal Investigator: Depei Wu, M.D., Ph.D.         
Sub-Investigator: Jia Chen, M.D.         
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.         
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
European Group for Blood and Marrow Transplantation
Investigators
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Principal Investigator: Depei Wu, M.D., Ph.D. The First Affiliated Hospital of Soochow University
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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT02059720    
Other Study ID Numbers: SZ3702
ChiCTR-TRC-14004196 ( Registry Identifier: Chinese Clinical Trial Registry (ChiCTR) )
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Keywords provided by The First Affiliated Hospital of Soochow University:
acute myeloid leukemia
allogeneic hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation
maintenance treatment
hematopoietic stem cell transplantation
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms