A Prospective, Interventional Study Assessing Response to Cytarabine, Daunorubicin and Etoposide (ADE) for First Relapse of Paediatric Acute Myeloid Leukemia

Phase 2

• Conditions: Acute Myeloid Leukemia, in Relapse
• Interventions: Drug: ADE Protocol

• Registration Number: NCT03053206
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Brief Summary

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 A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-10
• Last Update Submitted: 2017-02-10
• Study Start: 2017-02-15
• Study First Posted: 2017-02-15
• Last Update Posted: 2017-02-15
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADE arm	ADE Protocol	ADE arm Cytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days

Primary Outcome Measures

Name	Time	Method
complete remission (CR) rate	Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier	To assess the complete remission (CR) rate with the use of ADE chemotherapy in relapsed acute myeloid leukemia (AML) after first CR

Secondary Outcome Measures

Name	Time	Method
Event free survival (EFS) and overall survival(OS)	2 year	To determineevent free survival(EFS) and overall survival(OS)
toxicity of chemotherapy	Day 28 ± 7 of treatment	To assess the toxicity of chemotherapy using CTCAE 4.0
clonal evolution	Day 28 ± 7 of treatment	To evaluate clonal evolution using cytogenetics \&RT-PCR panel
minimal residual disease (MRD)	Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier	To assess minimal residual disease (MRD) by using flow cytometry
cardiac function	Day 28 ± 7 of treatment	To evaluate cardiac function using 2 Dimensional Echocardiography