- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03053206
A Prospective, Interventional Study Assessing Response to Cytarabine, Daunorubicin and Etoposide (ADE) for First Relapse of Paediatric Acute Myeloid Leukemia
February 10, 2017 updated by: ARUN GARG, MD, DM, All India Institute of Medical Sciences, New Delhi
RESPONSE TO CYTARABINE, DAUNORUBICIN AND ETOPOSIDE (ADE) AT FIRST RELASPE IN CHILDHOOD AML
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A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
84
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ARUN GARG, DM
- Phone Number: 9968588792
- Email: arungarg_aiims@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Either gender with age ≤18 years at initial diagnosis
- AML(non-M3) patients at first relapse (medullary)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complete remission (CR) rate
Time Frame: 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
|
Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event free survival (EFS) and overall survival(OS)
Time Frame: 2 year
|
To determineevent free survival(EFS) and overall survival(OS)
|
2 year
|
toxicity of chemotherapy
Time Frame: Day 28 ± 7 of treatment
|
To assess the toxicity of chemotherapy using CTCAE 4.0
|
Day 28 ± 7 of treatment
|
clonal evolution
Time Frame: Day 28 ± 7 of treatment
|
To evaluate clonal evolution using cytogenetics &RT-PCR panel
|
Day 28 ± 7 of treatment
|
minimal residual disease (MRD)
Time Frame: Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
|
To assess minimal residual disease (MRD) by using flow cytometry
|
Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
|
cardiac function
Time Frame: Day 28 ± 7 of treatment
|
To evaluate cardiac function using 2 Dimensional Echocardiography
|
Day 28 ± 7 of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 15, 2017
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
February 7, 2017
First Submitted That Met QC Criteria
February 10, 2017
First Posted (Actual)
February 15, 2017
Study Record Updates
Last Update Posted (Actual)
February 15, 2017
Last Update Submitted That Met QC Criteria
February 10, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IECPG-660/22.12.2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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