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

Phase 3

• Conditions: Acute Myeloid Leukemia
• Interventions: Procedure: HSCT

• Registration Number: NCT02059720
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 212

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
auto	HSCT	patients receive autologous SCT
haplo	HSCT	patients receive haplo-SCT

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Fisrt Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China