RESPONSE TO CYTARABINE, DAUNORUBICIN AND ETOPOSIDE (ADE) AT FIRST RELASPE IN CHILDHOOD AM
Phase 2
- Conditions
- Health Condition 1: null- RELAPSED AM
- Registration Number
- CTRI/2017/02/007757
- Lead Sponsor
- DEPARTMENT OF MEDICAL ONCOLOGY AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 84
Inclusion Criteria
1 Either gender with age <=18 years at initial diagnosis
2 AML(non-M3) patients at first relapse (medullary)
Exclusion Criteria
1Primary refractory AML &secondary AML
2More than or equal to 2 relapses of AML
3Symptomatic cardiac dysfunction (CTCAE Grade 3 or 4)
4Active infection(pneumonia etc.)
5Any other organ dysfunction (CTCAE Grade 4)
6Patients not willing to consent for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1To determineevent free survival(EFS) and overall survival(OS) <br/ ><br> <br/ ><br>2To assess the toxicity of chemotherapy using CTCAE 4.0 <br/ ><br> <br/ ><br>3To evaluate clonal evolution using cytogenetics &RT-PCR panel <br/ ><br> <br/ ><br>4To assess minimal residual disease (MRD) <br/ ><br> <br/ ><br>5 To evaluate cardiac functionTimepoint: not fixed