A clinical trial to study efficacy and toxicity of two doses of Ara-c in Acute Myeloid Leukemia , 18 gm/m2 and 12 gm/m2 for 3 cycles each

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 - AML-HIDAC 12/18 study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/11/003104

Enrollment

180

Registered

2012-11-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute Myeloid Leukemia

Interventions

Intervention1: Ara-c at 18 gm/m2 X 3 cycles: Arm A - 18 gm/m2 for 3 cycles( 3 gm/m2 BD , d1,3,5) Control Intervention1: Ara-c at 12 gm/m2 X 3 cycles: Arm B- 12 gm/m2 (2 gm/m2 BD D1,3,5) for 3 cycles

Eligibility

Inclusion criteria

Inclusion criteria: there shall be no upper age limit, if performance status permits patients of any age can be enrolled - Confirmation of Acute Myeloid Leukemia by morphologic, immunophenotypic analysis - Suitable for HIDAC as consolidation

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To analyze Relapse free survivalTimepoint: at 1 yr of follow up	—

Secondary

Measure	Time frame
2. To analyze Overall survival, Median time to relapse And Toxicity- Haematological and Non Haematological in the two armsTimepoint: at 1 yr	—

Countries

India

Contacts

Public ContactPrashant Mehta

All India Institute of Medical Sciences, New Delhi ,

vinodraina@hotmail.com011-26593578

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026