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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Procedure: HSCT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myeloid leukemia, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, maintenance treatment, hematopoietic stem cell transplantation