A prospective, open label, randomized, active control, parallel design, comparative pharmacokinetics study of Intramuscular Pegaspargase (Hamsyl) of Gennova Biopharmaceuticals Ltd versus Intramuscular Oncaspar® in pediatric patients with relapsed cases of Acute Lymphoblastic Leukemia (ALL)

Completed

• Conditions: Acute lymphoblastic leukemia [ALL],

• Registration Number: CTRI/2016/02/006589
• Lead Sponsor: Gennova Biopharmaceuticals Ltd

Brief Summary

Pharmacokinetic of Pegaspargase (Hamsyl) will be compared with Pegaspargase (Oncaspar) given intramuscularly in patients with relapsed cases of Acute Lymphoblastic Lymphoma (ALL).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-02
• Study Completion: 2018-05-01
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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

• 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study area under the L-asparaginase activity - time profile following administration of the two formulations of pegaspargase	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 Outcome Measures

Name	Time	Method
To study amino-acid depletion profile and to study immunogenicity of Pegaspargase including the detection of binding and neutralizing antibodies compared to Oncaspar	Day 0, 2nd and 3rd week
To compare grade 3/4 non hematological adverse reactions	Not applicable

Trial Locations

Locations (1)

Tata Memorial Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Centre

🇮🇳Mumbai, MAHARASHTRA, India

Dr Shripad Dinanath Banavali

Principal investigator

02224177000

banavali_2000@yahoo.com