Comparison of a condensed schedule of high dose cytarabine consolidation to the conventional schedule of high dose cytarabine consolidation in the treatment of acute myeloid leukemia

HIGH DOSE CYTARABINE IN DAILY (1, 2, 3) VERSUS ALTERNATE DAY (1, 3, 5) SCHEDULE FOR CONSOLIDATION IN ACUTE MYELOID LEUKEMIA: A COMPARATIVE STUDY - HIDAC 123

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025475

Enrollment

Registered

2020-05-29

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: C920- Acute myeloblastic leukemia

Interventions

Intervention1: HIDAC 123: High dose cytarabine (3g/m2) given 12 hourly for a total of 6 doses, on consecutive days 1,2 and 3 of every cycle Control Intervention1: HIDAC 135: High dose cytarabine (3g/m

Eligibility

Inclusion criteria

Inclusion criteria: 1. De novo AML, 2. Secondary AML (sAML) with a preceding history MDS/MPN, and 3. Therapy-related AML (tAML)

Exclusion criteria

Exclusion criteria: 1. Acute promyelocytic leukemia 2. Concomitant renal (creatinine > 1.5 x upper normal serum level) or hepatic (bilirubin, AST or ALP > 2 x upper normal serum level) dysfunction 3. Cardiac dysfunction (NYHA III/IV), 4. Uncontrolled infectious disease, 5. Primary coagulation disturbance, 6. Performance status (Eastern Cooperative Oncology Group) > 2 7. Active concomitant malignant disease

Design outcomes

Primary

Measure	Time frame
Time to hematologic recoveryTimepoint: Time to hematologic recovery: i. Time to Neutrophil recovery ii. Time to Platelet recovery	—

Secondary

Measure	Time frame
Antibiotic and antifungal requirementsTimepoint: end of chemotherapy cycle;The incidence of adverse effects: infections/febrile neutropenia/septic shockTimepoint: end of chemotherapy cycle;The incidence of drug toxicity due to the condensed dosing scheduleTimepoint: end of chemotherapy cycle;Transfusion support needed (number of units of RDP/PRBC required)Timepoint: end of chemotherapy cycle	—

Countries

India

Contacts

Public ContactDr Shouriyo Ghosh

IHTM, Medical College and Hospital, Kolkata

samanta_sambit@yahoo.co.in7001455633

Outcome results

None listed

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