One-third to one-half of patients with AML relapse and in general relapsed AML patients have a poor prognosis. The treatment of relapsed AML consists of induction chemotherapy followed by Allogenic Stem Cell Transplant (ASCT). However, at present there is no standard salvage chemotherapy regimen for relapsed AML, as no study has shown any one regimen to be significantly superior. Anthracyclines, Fludarabine, Etoposide and cytarabineare active agents in AMLand have been used as monotherapy and in combination in refractory and relapsed AML patients. According to previous studies the present CR rate of different regimens ranges from 50-70%. A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately 70%. Therefore, we have planned this study to test the efficacy and toxicity of ADE induction chemotherapy in relapsed AML patients in a prospective manner.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
ADE chemotherapy Cytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days
complete remission (CR) rate
To assess the complete remission (CR) rate with the use of ADE chemotherapy in relapsed acute myeloid leukemia (AML) after first CR
Time frame: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
Event free survival (EFS) and overall survival(OS)
To determineevent free survival(EFS) and overall survival(OS)
Time frame: 2 year
toxicity of chemotherapy
To assess the toxicity of chemotherapy using CTCAE 4.0
Time frame: Day 28 ± 7 of treatment
clonal evolution
To evaluate clonal evolution using cytogenetics \&RT-PCR panel
Time frame: Day 28 ± 7 of treatment
minimal residual disease (MRD)
To assess minimal residual disease (MRD) by using flow cytometry
Time frame: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
cardiac function
To evaluate cardiac function using 2 Dimensional Echocardiography
Time frame: Day 28 ± 7 of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.