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

Acute Myeloid Leukemia, in Relapse Clinical Trial

Official title:

RESPONSE TO CYTARABINE, DAUNORUBICIN AND ETOPOSIDE (ADE) AT FIRST RELASPE IN CHILDHOOD AML

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03053206
• Other study ID #: IECPG-660/22.12.2016
• Status: Not yet recruiting
• Phase: Phase 2
• First received: February 7, 2017
• Last updated: February 10, 2017
• Start date: February 15, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2017
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: ARUN GARG, DM
• Phone: 9968588792
• Email: arungarg_aiims[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

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 A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia, in Relapse
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Recurrence

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Outcome

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