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

NCT01615757 | Unknown Phase 3 DMC

• 1 other identifier: AML HIDAC, AIIMS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Keywords

AML; Acute Myeloid Leukemia; Cytarabine dose; Ara-c dose; Consolidation

Outcome Measures

Primary Outcomes (1)

• Relapse free survival at 1 yr of follow up

  1 year

Secondary Outcomes (1)

• Toxicity- Haematological and Non -Haematological

  at 1 yr

Study Arms (2)

Arm B, Ara-c - 12 gm/m2

EXPERIMENTAL

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

Arm A. Ara-c 18 gm/m2

ACTIVE COMPARATOR

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

Interventions

Ara-c DRUG

IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 3 gm/m2 /dose

Also known as: Cytosar, Cytarabine

Arm A. Ara-c 18 gm/m2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmation of Acute Myeloid Leukemia by morphologic, immunophenotypic analysis
• Suitable for HIDAC as consolidation
• AML with underlying MDS will be included

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

AIIMS

Delhi, National Capital Territory of Delhi, 110001, India

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Prashant Mehta, MD

  AIIMS, Delhi, India

  PRINCIPAL INVESTIGATOR

• Vinod Raina, MD

  AIIMS, Delhi

  STUDY CHAIR

Central Study Contacts

Prashant Mehta, MD

CONTACT

09013590847; prashantcipher@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident , Department of Medical Oncology

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 11, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

IN (1)