Safety and Efficacy Study of Ara-c at 18 gm/m2 Versus 12 gm/m2 for 3 Cycles Each in AML Consolidation
NCT ID: NCT01615757
Last Updated: 2012-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2012-08-31
2014-09-30
Brief Summary
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Detailed Description
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* 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-
1. toxicity
2. details of antimicrobials
3. supportive care ( including transfusions)
4. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Ara-c
IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 2 gm/m2 /dose
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
Ara-c
IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 3 gm/m2 /dose
Interventions
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Ara-c
IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 3 gm/m2 /dose
Ara-c
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Suitable for HIDAC as consolidation
* AML with underlying MDS will be included
Exclusion Criteria
* 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
ALL
No
Sponsors
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All India Institute of Medical Sciences
OTHER
Responsible Party
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Prashant Mehta
Senior Resident , Department of Medical Oncology
Principal Investigators
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Prashant Mehta, MD
Role: PRINCIPAL_INVESTIGATOR
AIIMS, Delhi, India
Vinod Raina, MD
Role: STUDY_CHAIR
AIIMS, Delhi
Locations
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AIIMS
Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Prashant Mehta, MD
Role: primary
Other Identifiers
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AML HIDAC, AIIMS
Identifier Type: -
Identifier Source: org_study_id