Clinical trial · Interventional
Safety and Efficacy Study of Ara-c at 18 gm/m2 Versus 12 gm/m2 for 3 Cycles Each in AML Consolidation
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ara-c | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm B, Ara-c - 12 gm/m2
- description
- Arm B will receive HIDAC at 12 gm/m2/cycle for 3 cycles , i.e. 2 gm/m2 BD , Day 1,3,5
- interventionNames
- Drug: Ara-c
- type
- ACTIVE_COMPARATOR
- label
- Arm A. Ara-c 18 gm/m2
- description
- Arm A will receive HIDAC at 18 gm/m2/cycle for 3 cycles , i.e. 3 gm/m2 BD , Day 1,3,5
- interventionNames
- Drug: Ara-c
Primary outcomes (1)
- measure
- Relapse free survival at 1 yr of follow up
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available