Acute Myeloid Leukemia
Conditions
Keywords
acute myeloid leukemia, hematopoietic stem cell microtransplantation
Brief summary
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).
Detailed description
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.
Interventions
PROCEDUREhematopoietic stem cell microtransplantation-long-term
Stem cell infusion are administrated once three months for 3 times with the cell count of 3\*10\^8/kg/once.
PROCEDUREhematopoietic stem cell microtransplantation-short-term
Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 3\*10\^8/kg/once.
DRUGConditioning for CR group
For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).
DRUGConditioning for Non-CR group
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).
Sponsors
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Peking University People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Zhujiang Hospital
Nanfang Hospital, Southern Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* AML patients who have received induction chemotherapy with moderate-high dose Ara-C and 3 courses consolidate chemotherapy * Intolerance or unwillingness of allogeneic HSCT * Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion criteria
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CR rate | 2 years | The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation |
| relapse rate | 2 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years | — |
| Disease-free Survival | 2 years | — |
| Incidence of chimerism | 2 years | 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. |
Countries
China
Contacts
Primary ContactFen Huang
Outcome results
None listed