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

NCT ID: NCT03053206

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2019-12-31

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 A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately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

Conditions

Acute Myeloid Leukemia, in Relapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADE arm

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

Group Type: EXPERIMENTAL

ADE Protocol

Intervention Type: DRUG

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

Interventions

ADE Protocol

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

Intervention Type: DRUG

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

ARUN GARG, MD, DM

SENIOR RESIDENT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

ARUN GARG, DM

Role: CONTACT

arungarg_aiims@yahoo.com

9968588792

Other Identifiers

IECPG-660/22.12.2016

Identifier Type: -

Identifier Source: org_study_id