Safety and Efficacy Study of Ara-c at 18 gm/m2 Versus 12 gm/m2 for 3 Cycles Each in AML Consolidation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Prashant Mehta, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01615757
First received: June 5, 2012
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

The study will be conducted in the Department of Medical Oncology and Department of Haematology , AIIMS, Delhi. A total of 180 patients of Acute Myeloid Leukemia who are in complete remission after induction chemotherapy will be enrolled into the study and will be further randomized to the two study arms . ARM- A will receive Ara-c at 18 gm /m2 for 3 cycles and ARM -B will receive Ara-c at 12 gm/m2 for 3 cycles according to the study protocol. Aim of the study will be to compare the efficacy of the two doses in terms of the relapse free survival and overall survival as well as time to relapse and toxicity /treatment related morbidity.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: Ara-c
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Relapse free survival at 1 yr of follow up [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity- Haematological and Non -Haematological [ Time Frame: at 1 yr ] [ Designated as safety issue: Yes ]

    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



Estimated Enrollment: 180
Study Start Date: August 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: 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 Name: Cytosar, Cytarabine
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
Drug: 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
Other Name: Cytosar, Cytarabine

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615757

Contacts
Contact: Prashant Mehta, MD 09013590847 prashantcipher@yahoo.co.in

Locations
India
AIIMS Recruiting
Delhi, India, 110001
Contact: Prashant Mehta, MD    09013590847    prashantcipher@yahoo.co.in   
Principal Investigator: Prashant Mehta, MD         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Prashant Mehta, MD AIIMS, Delhi, India
Study Chair: Vinod Raina, MD AIIMS, Delhi
  More Information

No publications provided

Responsible Party: Prashant Mehta, Senior Resident , Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01615757     History of Changes
Other Study ID Numbers: AML HIDAC, AIIMS
Study First Received: June 5, 2012
Last Updated: September 13, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by All India Institute of Medical Sciences, New Delhi:
AML
Acute Myeloid Leukemia
Cytarabine dose
Ara-c dose
Consolidation

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014