Health Condition 1: null- Pediatric intermediate risk B-cell Acute Lymphoblastic Leukemia patients
Conditions
Interventions
Intervention1: LAspase: Laspase will be given as a total of 4 doses at 10,000 IU/m2 on day 9, 12, 15, and 18. During this study, the enrolled patients will be given L-aspraginase by a research nurse o
Sponsors
ImPaCCT Foundation
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine, in a randomized fashion, the difference in L-asparaginase activity in all 4 generic L-asparaginase formulations. 2. To determine, in a randomized fashion, the difference in L-asparaginase activity in 4 generic L-asparaginase formulations compared to historical innovator controls Timepoint: Primary Outcome Measures 1. L-asparaginaseâ?? more than 100 IU/L Blood samples will be collected on day 12,15,18, and 21 and CSF samples will be collected on day 15. Asparaginase levels will not be monitored real time and will be analyzed at the end of the study period 2. Asparagine - serum asparagine less than 1 micro molar. Serum asparagine on day 21 will be measured. Analysis of the same will happen at end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine, in a randomized fashion, the incidence of L-asparaginase antibodies in all 4 generic L-asparaginase formulations 2. To determine the difference between batches of all 4 generic L-asparaginase formulations 3. To determine the difference of all 4 generic L-asparaginase formulations on hypersensitivity reactions. Timepoint: Secondary Outcome Measures 1. Humoral immune response - ELISA method, greater than 2.5 x control 2. L-asparaginase activity (API) of the formulations in vitro 3. Hypersensitivity reactions with L-asp administration CTCAE 4.03 grading for hypersensitivity grading. These will be analysed/calculated at end of study. | — |
Countries
India
Contacts
Public ContactDr Vikram Gota
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Outcome results
None listed