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

NCT03053206 | Unknown Phase 2

• 1 other identifier: IECPG-660/22.12.2016
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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 A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately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

Outcome Measures

Primary Outcomes (1)

• 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

  Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier

Secondary Outcomes (5)

• Event free survival (EFS) and overall survival(OS)

  2 year

• toxicity of chemotherapy

  Day 28 ± 7 of treatment

• clonal evolution

  Day 28 ± 7 of treatment

• minimal residual disease (MRD)

  Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier

• cardiac function

  Day 28 ± 7 of treatment

Study Arms (1)

ADE arm

EXPERIMENTAL

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

Drug: ADE Protocol

Interventions

ADE Protocol 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

ADE arm

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Either gender with age ≤18 years at initial diagnosis
• AML(non-M3) patients at first relapse (medullary)

You may not qualify if:

• Primary refractory AML \&secondary AML
• More than or equal to 2 relapses of AML
• Symptomatic cardiac dysfunction (CTCAE Grade 3 or 4)
• Active infection(pneumonia etc.)
• Any other organ dysfunction (CTCAE Grade 4)
• Patients not willing to consent for the study

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

DAV regimen

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

ARUN GARG, DM

CONTACT

9968588792; arungarg_aiims@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SENIOR RESIDENT

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 15, 2017
• Study Start: February 15, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share