Acute Myeloid Leukemia
Conditions
Keywords
acute myeloid leukemia, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, maintenance treatment, hematopoietic stem cell transplantation
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.
Interventions
PROCEDUREHSCT
Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.
Sponsors
European Society for Blood and Marrow Transplantation
The First Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leukemia-Free Survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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. |
| Cumulative relapse incidence | Five years | Defined as the cumulative incidence of morphological relapse after the day of graft infusion. |
| Non-relapse Mortality | 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. |
| Cumulative incidence of engraftment | 180 days | Defined as the cumulative incidence of durable complete donor chimerism detected by STR-PCR. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Five years | Including incidence and severity of acute and chronic GVHD, activity of daily living, psychological status, recovery of professional activity, social adaption, etc. |
Countries
China
Contacts
Primary ContactDepei Wu, M.D., Ph.D.
Backup ContactJia Chen, M.D.
Outcome results
None listed