Health Condition 1: null- RELAPSED AML
Conditions
Interventions
Intervention1: ADE (cytarabine, daunorubicin and etoposide) chemotherapy: ADE Chemotherapy with:
Cytarabine 100mg/m2 BD IV push Day 1-10
Daunorubicin 50mg/m2 IV infusion over 30 minutes Day 1-3 and
Sponsors
DEPARTMENT OF MEDICAL ONCOLOGY AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1 Either gender with age 2 AML(non-M3) patients at first relapse (medullary)
Exclusion criteria
Exclusion criteria: 1 Primary refractory AML &secondary AML 2 More than or equal to 2 relapses of AML 3 Symptomatic cardiac dysfunction (CTCAE Grade 3 or 4) 4 Active infection(pneumonia etc.) 5 Any other organ dysfunction (CTCAE Grade 4) 6 Patients not willing to consent for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the complete remission rate with the use of ADE chemotherapy in relapsed acute myeloid leukemia after first complete remission rateTimepoint: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To determineevent free survival(EFS) and overall survival(OS) 2 To assess the toxicity of chemotherapy using CTCAE 4.0 3 To evaluate clonal evolution using cytogenetics &RT-PCR panel 4 To assess minimal residual disease (MRD) 5 To evaluate cardiac functionTimepoint: not fixed | — |
Countries
India
Contacts
Public ContactARUN GARG
AIIMS
Outcome results
None listed