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

All India Institute Of Medical Science (AIIMS)

Status and phase: Unknown; Phase 2

Conditions: Acute Myeloid Leukemia, in Relapse

Treatments: Drug: ADE Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03053206

IECPG-660/22.12.2016

Details and patient eligibility

About

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 A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately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

Enrollment: 84 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

ADE arm

Experimental group

Description:

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

Treatment:

Drug: ADE Protocol