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

• Status: Unknown status
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Treatments: Cytarabine

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