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Effect of different steroids in ALL cancer patients

Not Applicable
Completed
Conditions
Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Registration Number
CTRI/2022/01/039113
Lead Sponsor
All India Institute of Medical Sciences Rishikesh
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
75
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

1.Infantile acute lymphoblastic leukemia (age < 1 year).

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
To compare Day 33 bone marrow morphological response in the two treatment groups. <br/ ><br>2. To compare Day 15 bone marrow morphological response & MRD status in the two treatment groups as per protocol. <br/ ><br>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). <br/ ><br>Timepoint: 0 days and 33 days
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