Haplo-SCT vs ASCT With or Without Decitabine in AML CR1
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
acute myeloid leukemia, allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, maintenance treatment, hematopoietic stem cell transplantation
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: HSCT
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
The Fisrt Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Status: Recruiting
Contact: Depei Wu, M.D., Ph.D. - +86 512 6778 1856 - wudepei@medmail.com.cn
Start Date
February 2014
Completion Date
December 2018
Sponsors
The First Affiliated Hospital of Soochow University
Source
The First Affiliated Hospital of Soochow University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page