The purpose of this study is to evaluate the efficacy of hematopoietic stem cell microtransplantation for in acute myeloid leukemia (AML)patients who can not receive hematopoietic stem cell transplantation (HSCT).
Despite allogeneic HSCT is the only curative therapy for AML, some patients can not receive transplantation due to intolerance of transplant-related toxicity or unwillingness of HSCT. For these patients, microtransplantation seems an optional therapy. However, the efficacy still remain unclear.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Stem cell infusion are administrated once three months for 3 times with the cell count of 3\*10\^8/kg/once.
Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 3\*10\^8/kg/once.
For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGCR rate
The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation
Time frame: 2 years
relapse rate
Time frame: 2 years
Overall Survival
Time frame: 2 years
Disease-free Survival
Time frame: 2 years
Incidence of chimerism
Incidence of chimerism will be evaluated in the patients. Both peripheral-blood cells and bone marrow are tested for hematopoietic donor chimerism by a standard cytogenetic analysis and a semiquantitative PCR-based analysis of the short tandem repeats.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
For the patients in Non-CR group, the conditioning regimens include: IAC（IDA 12mg/m2 d1-3，Ara-C 200 mg/m2 d1-7， Cladribine 5mg/m2 d1-5) or HD Ara-C(high-dose Ara-c 3g/m2 q12h d1-3).