Acute Myeloid Leukemia
Conditions
Keywords
Acute Myeloid Leukemia, microtransplantationHLA-mismatched microtransplantation, nonmyeloablative stem cell transplantation, graft-versus-host disease
Brief summary
Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.
Detailed description
The optimal therapy for intermediate-risk patients with acute myeloid leukemia (AML) in first complete remission (CR1) is uncertain. Recent studies shown that microtransplantation (MST) can improve survival in AML-CR1 patients. However, a comparison study between the MST and nonmyeloablative stem cell transplantation (NST) is lacking. 156 intermediate-risk AML-CR1 patients aged 9 to 59 years were enrolled in this study. Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.
Interventions
GENETICHLA mismatched stem cell
HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy
GENETICHLA matched stem cell
HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen
DRUGcyclosporine A
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
DRUGMycophenolate mofetil
The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
DRUGAra-C
2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose
DRUGfludarabine
30 mg/m2/d for 5days
DRUGanti-lymphocyte globulin
1.5-2 mg/kg/d for 4 days
DRUGcyclophosphamide
40 mg/kg/d for 2 days
Sponsors
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have elderly (9-59 ages) AML pathologically confirmed per WHO guidelines. * Patients WITH intermediate-risk AML-CR1 * Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2. * Patients must have a HLA mismatched donor who should be able to provide informed consent. * All genders and races are eligible. * ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min * By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range. * Donors must be able to safely undergo leukapheresis.
Exclusion criteria
* received operation 4 weeks before randomization * acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase; * active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol * Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant. * There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA). * Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection * Any situation processed by the PI that will be damaged to the patients safety. * Patients and / or authorized family member refuse to sign the consent. attend other clinical researchers in 3 months. * Donors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 10 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| treatment-related mortality | 2 years | — |
| donor chimerism or microchimerism | 10 years | — |
| WT1+CD8+CTL | 10 years | donor versus leukemia effect |
| GVHD | 10 years | — |
| disease free survival | 10 years | — |
Countries
China
Outcome results
None listed