AML in Remission
Conditions
Brief summary
This study evaluates Idarubicin (IDA) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly AML in first remission.
Interventions
DRUGIdarubicin
Idarubicin 10mg/m²/day, D1 (IV)
DRUGID cytarabine
Cytarabine 1.5g/m² /12h, D1-D3 (IV)
Sponsors
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed de novo AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy. * Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia) * No contraindication to anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) \< 50% * Age ≥ 60 years and \< 75 years * ECOG performance status ≤2 * Written informed consent * No psychological, familial, social, or geographic reason that would compromise clinical follow up
Exclusion criteria
* Relapsed or refractory AML * Patients with acute promyelocytic leukemia (APL) * Patients with secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML) * Severe pshyciatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment * Subjects for which allogeneic HSCT is planned in CR1 * Known allergic or hypersensitivity to idarubicin or cytarabine or to any of the test compounds, materials * Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk * A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse free survival | 2 years | RFS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Residual Disease | 6, 9, 12,18 and 24 months | Immunophenotypic characterization of human bone marrow cells will be done to determine MRD |
| Overall survival | 2 years | OS |
| Toxicities | enitire study course until 2 years | Number and CTC grade of all adverse events related to study treatment analyzed in an descriptive way |
Countries
China
Contacts
Primary ContactJianda Hu, Prof.M.D.Ph.D
Outcome results
None listed