Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
Intervention1: Hamsyl (Pegaspargase): Test - Hamsyl (Pegaspargase)
Control Intervention1: Oncaspar: Hamsyl (Pegaspargase) of Gennova will be compared with Oncaspar
Sponsors
Gennova Biopharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Relapsed cases of Acute Lymphoblastic Leukemia (ALL) Diagnostic Criteria: presence of blasts in the bone marrow that are myeloperoxidase negative and TdT positive and/or expressed an ALL immunophenotype with monoclonal antibodies directed against precursor B-cell or T-cell lineage
Exclusion criteria
Exclusion criteria: Patients receiving cytotoxic regimen without pegaspargase or other diseased status will be excluded. Contraindication as per SPC History of thrombosis with prior L-asparaginase therapy History of pancreatitis with prior L-asparginase therapy History of hemorrhagic events with prior L-asparaginase therapy Patients with ALL FAB L3 and blastic crisis of chronic myelogenous leukemia as well as HIV-positive patients were excluded Billirubin levels more than 34.2 µM (2 mg/dL) Creatinine levels more than 178.8 µM (2 mg/dL).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study area under the L-asparaginase activity - time profile following administration of the two formulations of pegaspargaseTimepoint: Blood samples will be collected after single dose of Pegaspargase via an indwelling venous access on day 2 of the cycle 1 at pre dose, 1hr, 6hr, 24 hr, day 2, day 5, day 7 and day 13 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare grade 3/4 non hematological adverse reactionsTimepoint: Not applicable;To study amino-acid depletion profile and to study immunogenicity of Pegaspargase including the detection of binding and neutralizing antibodies compared to OncasparTimepoint: Day 0, 2nd and 3rd week | — |
Countries
India
Contacts
Public ContactDr K Manjunath Nookala
Tata Memorial Hospital
Outcome results
None listed