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
2 other identifiers
interventional
212
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2014
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 10, 2014
CompletedFirst Posted
Study publicly available on registry
February 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 5, 2020
February 1, 2020
6.8 years
February 10, 2014
February 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Overall survival
Five years
Cumulative relapse incidence
Five years
Non-relapse Mortality
Five years
Cumulative incidence of engraftment
180 days
Other Outcomes (1)
Quality of Life
Five years
Study Arms (2)
auto
ACTIVE COMPARATORpatients receive autologous SCT
haplo
ACTIVE COMPARATORpatients receive haplo-SCT
Interventions
Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Fisrt Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Depei Wu, M.D., Ph.D.
The First Affiliated Hospital of Soochow University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2014
First Posted
February 11, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
February 5, 2020
Record last verified: 2020-02