- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01615757
Safety and Efficacy Study of Ara-c at 18 gm/m2 Versus 12 gm/m2 for 3 Cycles Each in AML Consolidation (Ara-c)
Comparison of Ara-c 12 gm/m2 vs 18 gm/m2 Per Cycle for 3 Cycles Each as Consolidation in AML ; An Open Label Randomized Non-inferiority Study
Study Overview
Detailed Description
Objectives
- To compare the efficacy of two different doses of Cytarabine during consolidation therapy for newly diagnosed patients of Non APML - Acute Myeloid Leukemia who are in CR post induction
- To compare the toxicity of the two different Cytarabine doses
Primary end point
- Relapse free survival at 1 yr from randomization
- Relapse will be defined as >5 % leukemic blasts in the marrow aspirate or new extramedullary disease anytime after randomization
Secondary end points
- Overall survival
- Median time to relapse
- Toxicity- Haematological and Non -Haematological
Inclusion criteria
- Confirmation of Acute Myeloid Leukemia by morphologic, immunophenotypic analysis
- Suitable for HIDAC as consolidation
- AML with underlying MDS will be included
Exclusion criteria
- Previous AML chemotherapy [Hydroxyurea - not an exclusion.]
- CML-BC
- Concurrent active malignancy
- HIV infection, Uncontrolled Hepatitis B/C
- Patients being considered for upfront PBSCT (before completion of CONSOLIDATION)
- Serum Bilirubin > 2
- APML
- Delayed recovery of blood counts /persistent active infection > 45 days from start of induction
- Patients receiving reinduction with HIDAC
- Therapy related AML Methodology
- The period of enrollment will be from July 1, 2012 to September 30 ,2013
- Baseline information will be recorded in a preformulated proforma designed for analysis at a later date
Treatment
- Standard 3 + 7 INDUCTION with Daunomycin and Cytarabine with DNR at 60- 90 mg/m2 as per the PS and comorbidities/active infections at presentation
- Bone marrow examination - D+ 28 of induction or earlier if needed . Patients not in CR - reinduction regimen as per discretion of treating physician
- Patients in complete morphological remission ( after 1 or 2 inductions) : will receive consolidation with HIDAC and will be randomized into the two study arms after written Informed Consent: Arm A and B with 90 patients in each arm Arm A will receive HIDAC at 18 gm/m2/cycle for 3 cycles , i.e. 3 gm/m2 BD , Day 1,3,5 Arm B will receive HIDAC at 12 gm/m2/cycle for 3 cycles , i.e. 2 gm/m2 BD , Day 1,3,5
sample size
- Assuming a RFS of 60 % at 1 yr in each arm and keeping a non-inferiority margin of 20 % , Alpha at 5 % ,75 patients are required in each arm on the basis of statistical calculation.
- 15 patients added in each arm to account for losses
- Total required in each arm = 90
- ANC> 1000 , Platelet count > 1 lac required to start HIDAC
Detailed information of the course of all the chemotherapy cycles will be recorded including-
- toxicity
- details of antimicrobials
- supportive care ( including transfusions)
- Use of growth factors
- Cytogenetic analysis using standard technique of chromosomal banding
- Molecular analysis for mutation of FLT3-ITD will be performed
- Risk stratification will be done as per guidelines
- Patients in both arms will be kept under close follow up and will be assessed with blood counts /PS , 2 monthly / or earlier as clinically indicated
Statistical Analysis
- Qualitative data will be analyzed using the Chi-square test
- Quantitative data will be compared by using t-test /Mann Whitney test
- Besides this survival analysis will be carried out.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Prashant Mehta, MD
- Phone Number: 09013590847
- Email: prashantcipher@yahoo.co.in
Study Locations
-
-
-
Delhi, India, 110001
- Recruiting
- AIIMS
-
Contact:
- Prashant Mehta, MD
- Phone Number: 09013590847
- Email: prashantcipher@yahoo.co.in
-
Principal Investigator:
- Prashant Mehta, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Confirmation of Acute Myeloid Leukemia by morphologic, immunophenotypic analysis
- Suitable for HIDAC as consolidation
- AML with underlying MDS will be included
Exclusion Criteria:
- Previous AML chemotherapy [Hydroxyurea - not an exclusion.]
- CML-BC
- Concurrent active malignancy
- HIV infection, Uncontrolled Hepatitis B/C
- Patients being considered for upfront PBSCT (before completion of CONSOLIDATION)
- Serum Bilirubin > 2
- APML
- Delayed recovery of blood counts /persistent active infection > 45 days from start of induction
- Patients receiving reinduction with HIDAC
- Therapy related AML
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm B, Ara-c - 12 gm/m2
Arm B will receive HIDAC at 12 gm/m2/cycle for 3 cycles , i.e. 2 gm/m2 BD , Day 1,3,5
|
IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 3 gm/m2 /dose
Other Names:
IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 2 gm/m2 /dose
Other Names:
|
Active Comparator: Arm A. Ara-c 18 gm/m2
Arm A will receive HIDAC at 18 gm/m2/cycle for 3 cycles , i.e. 3 gm/m2 BD , Day 1,3,5
|
IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 3 gm/m2 /dose
Other Names:
IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 2 gm/m2 /dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relapse free survival at 1 yr of follow up
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity- Haematological and Non -Haematological
Time Frame: at 1 yr
|
The following variables will be compared in the two arms to - -Nadir blood counts,Ara c related fever ,Allergic or skin reactions,Alopecia,Diarrhea ,Stomatitis,Bleeding ,Febrile neutropenia,Infection(fungal /bacterial/viral),Liver related event,ocular toxicity,Neurologic event,Peripheral neuropathy,Cerebral/Cerebellar toxicity,Transfusions,Time to recovery of platelets,Time to recovery of neutrophils,Duration of Hospital stay,Emergency visits,Deaths,Use of growth factors |
at 1 yr
|
Collaborators and Investigators
Investigators
- Principal Investigator: Prashant Mehta, MD, AIIMS, Delhi, India
- Study Chair: Vinod Raina, MD, AIIMS, Delhi
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cytarabine
Other Study ID Numbers
- AML HIDAC, AIIMS
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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