A research study comparing 4 different brands of the medicine L-asparaginase, in children with B-cell blood cancer.
Not Applicable
Not yet recruiting
- Conditions
- Health Condition 1: null- Pediatric intermediate risk B-cell Acute Lymphoblastic Leukemia patients
- Registration Number
- CTRI/2018/08/015396
- Lead Sponsor
- ImPaCCT Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Intermediate risk precursor B cell ALL patients as defined by the ICICLE protocol:
1. Presenting WC greater than and/or equal to 50,000/mm3
2. No CNS disease
3. At risk clinical features like: bulky lymph nodes ( > 5 cm in peripheral region and in the chest > 5 cm on CT scan or occupying > 1/3rd diameter on chest x-ray) and/or bulky liver/spleen reaching beyond midway to umbilicus and/or presence of testicular disease. Absence of high risk cytogenetics including hypodiploidy.
Exclusion Criteria
1. Patients pre-treated before diagnosis
2. Pre-existing renal disease before starting treatment (Creatinine > 1.1 mg/dL)
3. Pre-existing hyperbiliribuinemia at diagnosis (Bilirubin > 2 mg/dL)
4. High Risk Patients as defined by ICICLE protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To determine, in a randomized fashion, the difference in L-asparaginase activity in all 4 generic L-asparaginase formulations. <br/ ><br> <br/ ><br>2. To determine, in a randomized fashion, the difference in L-asparaginase activity in 4 generic L-asparaginase formulations compared to historical innovator controls <br/ ><br>Timepoint: Primary Outcome Measures <br/ ><br>1. L-asparaginaseâ?? more than 100 IU/L <br/ ><br>Blood samples will be collected on day 12,15,18, and 21 and CSF samples will be collected on day 15. <br/ ><br>Asparaginase levels will not be monitored real time and will be analyzed at the end of the study period <br/ ><br> <br/ ><br>2. Asparagine - serum asparagine less than 1 micro molar. <br/ ><br>Serum asparagine on day 21 will be measured. <br/ ><br>Analysis of the same will happen at end of study. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. To determine, in a randomized fashion, the incidence of L-asparaginase antibodies in all 4 generic L-asparaginase formulations <br/ ><br> <br/ ><br>2. To determine the difference between batches of all 4 generic L-asparaginase formulations <br/ ><br> <br/ ><br>3. To determine the difference of all 4 generic L-asparaginase formulations on hypersensitivity reactions. <br/ ><br>Timepoint: Secondary Outcome Measures <br/ ><br>1. Humoral immune response - ELISA method, greater than 2.5 x control <br/ ><br>2. L-asparaginase activity (API) of the formulations in vitro <br/ ><br>3. Hypersensitivity reactions with L-asp administration <br/ ><br>CTCAE 4.03 grading for hypersensitivity grading. <br/ ><br> <br/ ><br>These will be analysed/calculated at end of study. <br/ ><br>