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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02059720
• Other study ID #: SZ3702
• Secondary ID: ChiCTR-TRC-14004
• Status: Recruiting
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: The First Affiliated Hospital of Soochow University
• Contact: Depei Wu, M.D., Ph.D.
• Phone: +86 512 67781856
• Email: wudepei[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Procedure:
• HSCT
Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.

Locations

Country	Name	City	State
China	The Fisrt Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	European Group for Blood and Marrow Transplantation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life	Including incidence and severity of acute and chronic GVHD, activity of daily living, psychological status, recovery of professional activity, social adaption, etc.	Five years
Primary	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	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
Secondary	Cumulative relapse incidence	Defined as the cumulative incidence of morphological relapse after the day of graft infusion.	Five years
Secondary	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
Secondary	Cumulative incidence of engraftment	Defined as the cumulative incidence of durable complete donor chimerism detected by STR-PCR.	180 days