Effect of different steroids in ALL cancer patients

Completed

• Conditions: Acute lymphoblastic leukemia [ALL],

• Registration Number: CTRI/2022/01/039113
• Lead Sponsor: All India Institute of Medical Sciences Rishikesh

Brief Summary

The proposed study will compare the efficacy ofdexamethasone versus prednisolone on treatment outcomes with respect to Day 33 MinimalResidual Disease during induction phase chemotherapy in pediatric ALL at AIIMSRishikesh, in view of no published data on this theme in Indian pediatric ALLpatients

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study Completion: 2023-03-31
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

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

Name	Time	Method
To compare bone marrow minimal residual disease (MRD) response by flowcytometry on day 33 of induction phase chemotherapy in the dexamethasone and prednisolone treatment groups	0 days and 33 days

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AIIMS Rishikesh; 🇮🇳 Dehradun, UTTARANCHAL, India

AIIMS Rishikesh

🇮🇳Dehradun, UTTARANCHAL, India

Dr Karthik Kumar

Principal investigator

9597675433

drkarthikkumar92@gmail.com