Clinical trial · Interventional
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
NCT02059720CI-TRIAL-00043163unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HSCT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- auto
- description
- patients receive autologous SCT
- interventionNames
- Procedure: HSCT
- type
- ACTIVE_COMPARATOR
- label
- haplo
- description
- patients receive haplo-SCT
- interventionNames
- Procedure: HSCT
Primary outcomes (1)
- measure
- Leukemia-Free Survival
- timeFrame
- Five years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.