Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
Intervention1: Dexamethosone: Dexamethasone 10 mg/m2/day intravenously x 14 days (days 1-14) followed by tapering over next 7 days
Control Intervention1: Prednisolone: Prednisolone 60 mg/m2/day orally
Sponsors
All India Institute of Medical Sciences Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed patients of acute lymphoblastic leukemia (both B-ALL & T-ALL), between 1 year to 24 years of age, of any gender, where informed consent of parent/guardian is available
Exclusion criteria
Exclusion criteria: 1.Infantile acute lymphoblastic leukemia (age 2.Patients of lymphoblastic lymphoma (LBL). 3.Relapsed cases of acute lymphoblastic leukemia. 4.Patients who have received dexamethasone, prednisolone or any other chemotherapy within 4 weeks of enrollment in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare bone marrow minimal residual disease (MRD) response by flowcytometry on day 33 of induction phase chemotherapy in the dexamethasone and prednisolone treatment groupsTimepoint: 0 days and 33 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare Day 33 bone marrow morphological response in the two treatment groups. 2. To compare Day 15 bone marrow morphological response & MRD status in the two treatment groups as per protocol. 3. To compare the toxicity profile in the two treatment groups â?? adverse events of any grade, and adverse events of grade 3-4 (CTCAE- Common Terminology Criteria For Adverse Events Version 5). Timepoint: 0 days and 33 days | — |
Countries
India
Contacts
Public ContactDr Karthik Kumar
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH
Outcome results
None listed