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

Primary Purpose

Acute Myeloid Leukemia, in Relapse

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ADE Protocol
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia, in Relapse

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ADE arm

    Arm 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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Event free survival (EFS) and overall survival(OS)
    To determineevent free survival(EFS) and overall survival(OS)
    toxicity of chemotherapy
    To assess the toxicity of chemotherapy using CTCAE 4.0
    clonal evolution
    To evaluate clonal evolution using cytogenetics &RT-PCR panel
    minimal residual disease (MRD)
    To assess minimal residual disease (MRD) by using flow cytometry
    cardiac function
    To evaluate cardiac function using 2 Dimensional Echocardiography

    Full Information

    First Posted
    February 7, 2017
    Last Updated
    February 10, 2017
    Sponsor
    All India Institute of Medical Sciences, New Delhi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03053206
    Brief Title
    A Prospective, Interventional Study Assessing Response to Cytarabine, Daunorubicin and Etoposide (ADE) for First Relapse of Paediatric Acute Myeloid Leukemia
    Official Title
    RESPONSE TO CYTARABINE, DAUNORUBICIN AND ETOPOSIDE (ADE) AT FIRST RELASPE IN CHILDHOOD AML
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 15, 2017 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    All India Institute of Medical Sciences, New Delhi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myeloid Leukemia, in Relapse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    84 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ADE arm
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    ADE Protocol
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    complete remission (CR) rate
    Description
    To assess the complete remission (CR) rate with the use of ADE chemotherapy in relapsed acute myeloid leukemia (AML) after first CR
    Time Frame
    Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
    Secondary Outcome Measure Information:
    Title
    Event free survival (EFS) and overall survival(OS)
    Description
    To determineevent free survival(EFS) and overall survival(OS)
    Time Frame
    2 year
    Title
    toxicity of chemotherapy
    Description
    To assess the toxicity of chemotherapy using CTCAE 4.0
    Time Frame
    Day 28 ± 7 of treatment
    Title
    clonal evolution
    Description
    To evaluate clonal evolution using cytogenetics &RT-PCR panel
    Time Frame
    Day 28 ± 7 of treatment
    Title
    minimal residual disease (MRD)
    Description
    To assess minimal residual disease (MRD) by using flow cytometry
    Time Frame
    Day 28 ± 7 of treatment or after recovery of blood counts whichever is earlier
    Title
    cardiac function
    Description
    To evaluate cardiac function using 2 Dimensional Echocardiography
    Time Frame
    Day 28 ± 7 of treatment

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ARUN GARG, DM
    Phone
    9968588792
    Email
    arungarg_aiims@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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