Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
Intervention1: Not applicable: Not applicable
Control Intervention1: Not applicable: Not applicable
Sponsors
Dr Chetan Dhamne
Gennova Biopharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Children less than equal to 15 years of age with B-ALL or T-ALL receiving PEG asparaginaseas per ICICLE 2014 or standard of care treatment protocol at TMH.
Exclusion criteria
Exclusion criteria: 1. Children who have received Asparginase as cytoreductive therapy for hyperleukocytosis will not be eligible for this study. 2. Children who receive native L asparaginase will not be eligible for the study. 3. Children who default treatment during induction of undergo induction death will be taken off study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of Grade I to II hypersensitivity reactions due to PEG asparaginase. 2. Incidence of Grade III and IV hypersensitivity reactions due to PEG asparaginase. 3. Incidence of neutralizing antibodies to PEG asparaginasein the presence ofhypersensitivity reactions and silent inactivation.Timepoint: Measure the anti-asparaginase antibodies on day 14 after the PEG asparaginase administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Volume of distribution, clearance, AUC, the half-life of PEG asparaginase in pediatric ALL patients. Timepoint: First sample will be collected at 48 hours after the PEG asparaginase injection, Second sample between 4th to 5th day, one sample between 6th to 8th day, one sample on day 14 (trough level) and 1 day after the PEG asparaginase administration. | — |
Countries
India
Contacts
Public ContactDr Chetan Dhamne
Tata Memorial Hospital
Outcome results
None listed