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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

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
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 groups0 days and 33 days
Secondary Outcome Measures
NameTimeMethod
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

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