Comparison of drugs used in the treatment of blood cancer in children.Escherichia coli asparaginase vs pegylated asparaginase
Phase 4
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
- Registration Number
- CTRI/2019/06/019520
- Lead Sponsor
- Dr Anand Srinivasan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
a)Patients of 1-18 years of age undergoing induction phase chemotherapy for newly diagnosed acute lymphoblastic leukemia.
b)Patients whose parent/guardian are willing to give consent and children willing to give assent.
Exclusion Criteria
a)Cases of ALL less than 1 year of age
b)Relapse cases of ALL
c)Prior history of hepatitis
d)Prior history of pancreatitis
e)Prior history of tuberculosis
f)Prior history of allergy to any of treatment medication used in the management of ALL.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of the asparagine levels of ALL patients taking asparaginase at the end of the study period (induction phase)Timepoint: at 33rd day of induction phase
- Secondary Outcome Measures
Name Time Method 1)Determination of asparagine levels at various time points as per the formulation provided. <br/ ><br>2)Determination of PK-PD relationship for native E. coli asparaginase and pegylated asparaginase during the induction phase of chemotherapy.Timepoint: E.coli asparaginase group-immediately prior to the drug administration, 20 minutes, 1hour, 4 hours, 24 hours and at 72 hours post the administration of the drug.PEG-asparaginase <br/ ><br>group immediately prior to the drug administration, 24 hours, 48 hours, 168 hours (at the end of 7 days), 336 hours (at the end of 14 days) post administration of the drug