Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
Intervention1: Hamsyl /Hamsyl Junior
(Pegaspargase Injection)
: 1000 IU/m2 as per PI discretion, single or twice dose as per risk stratification, for 35 days 2 days. Institutional-based chemother
Sponsors
Gennova Biopharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed and previously untreated patients with ALL, which has precursor B-, T- or early T-cell phenotype. 2. Age and gender: Age greater than or equal to 1 year and less than or equal to 18 years; male or female. 3. Diagnostic Criteria: Presence of blasts in the bone marrow that are myeloperoxidase negative and TdT positive and/or expressing an ALL immunophenotype with monoclonal antibodies against precursor B-cell or T-cell lineage as determined by morphology and multicolor flow cytometry. 4. T-cell lymphoblastic lymphoma confirmed by cytology or histology. 5. Willing to participate in the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previously treated patients who do not meet eligibility criteria and relapse cases of ALL. 2. ALL-L3 (mature B-cell ALL). 3. Patients receiving any other cytotoxic regimen without pegaspargase or other diseased status will be excluded. 4. Contraindications as per Hamsyl / Hamsyl Jr. package insert a. History of allergic reactions to pegaspargase b. History of thrombosis with prior L-asparaginase therapy c. History of pancreatitis with prior L-asparaginase therapy d. History of hemorrhagic events with prior L-asparaginase therapy 5. Patients with pro-B, mixed phenotypic leukemias, gamma- delta T-cell leukemia or lymphoma and blastic crisis of chronic myelogenous leukemia as determined by combination of flow cytometry, cytogenetics and molecular test will be excluded. 6. Patients with associated primary or secondary immunodeficiency syndromes, including HIV positive patients and/or bone marrow failure syndromes, and serology positive patients will be excluded. 7. Bilirubin levels more than 34.2 micromolar (2 mg/dL). 8. Creatinine levels more than 178.8 micromolar (2 mg/dL). 9. Patient is not willing to be part of study or not able to comply study protocol. 10. Known pregnancy or breast-feeding. 11. Any conditions that were defined in contraindication, warning and precaution section of Hamsyl / Hamsyl Jr. package insert. 12. Any conditions as per discretion of principal investigator (PI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety greater than or equal to grade 3 adverse eventsTimepoint: 5 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of asparaginase activityTimepoint: Pre-dose, pre second dose ( 2 day, as per risk stratification), & end of induction phase ( 2 days);Evaluation of asparagine depletionTimepoint: Pre-dose, pre second dose ( 2 day, as per risk stratification), & end of induction phase ( 2 days);Percentage of patients with bone marrow remission responseTimepoint: End of induction phase ( 2 days);Evaluation of anti-asparaginase antibodyTimepoint: Baseline, & end of induction phase ( 2 days) | — |
Countries
India
Contacts
Public ContactDr Ritu Singh
Gennova Biopharmaceuticals Limited
Outcome results
None listed