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Trial record 16 of 325 for:    CYTARABINE AND DAUNORUBICIN

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

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ClinicalTrials.gov Identifier: NCT03053206
Recruitment Status : Not yet recruiting
First Posted : February 15, 2017
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
ARUN GARG, MD, DM, All India Institute of Medical Sciences, New Delhi

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 A retrospective analysis (unpublished) conducted at IRCH, AIIMS on relapsed AML patients treated with ADE (Cytarabine, Daunorubicin and Etoposide) chemotherapy showed the CR rates of approximately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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia, in Relapse Drug: ADE Protocol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RESPONSE TO CYTARABINE, DAUNORUBICIN AND ETOPOSIDE (ADE) AT FIRST RELASPE IN CHILDHOOD AML
Estimated Study Start Date : February 15, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


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

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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Event free survival (EFS) and overall survival(OS) [ Time Frame: 2 year ]
    To determineevent free survival(EFS) and overall survival(OS)

  2. toxicity of chemotherapy [ Time Frame: Day 28 ± 7 of treatment ]
    To assess the toxicity of chemotherapy using CTCAE 4.0

  3. clonal evolution [ Time Frame: Day 28 ± 7 of treatment ]
    To evaluate clonal evolution using cytogenetics &RT-PCR panel

  4. 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

  5. cardiac function [ Time Frame: Day 28 ± 7 of treatment ]
    To evaluate cardiac function using 2 Dimensional Echocardiography



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053206


Contacts
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Contact: ARUN GARG, DM 9968588792 arungarg_aiims@yahoo.com

Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi

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Responsible Party: ARUN GARG, MD, DM, SENIOR RESIDENT, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT03053206     History of Changes
Other Study ID Numbers: IECPG-660/22.12.2016
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cytarabine
Daunorubicin
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Recurrence
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Etoposide
Etoposide phosphate
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic