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A study comparing intramuscular pegasparaginase made by Levim Lifetech Private Ltd (marketed by Mankind Pharma Ltd) with intramuscular pegasparaginase made by GBL in newly diagnosed Acute Lymphoblastic Leukemia (ALL) patients to see how the drug works in the body.

A prospective, open-label, randomized, active control, parallel design, comparative pharmacokinetics study of intramuscular Pegasparaginase manufactured by Levim lifetech Private Ltd, marketed by Mankind Pharma Ltd versus intramuscular pegasparaginase manufactured by GBL in newly diagnosed Acute Lymphoblastic Leukemia (ALL) patients. - NA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107222
Enrollment
24
Registered
2026-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]

Interventions

Intervention1: Cancrinase : By Mankind Pharma Ltd. Lyophilized powder, reconstitution to 5.0 ml vial containing 750 IU Pegasparaginase (Pegylated L-asparaginase per mL) Dose: 1000 IU/m2 Route of a

Sponsors

Dr. Chetan Dhamne
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children of either gender, aged 6 less than 18 yr newly diagnosed cases of B-Acute Lymphoblastic Leukemia (ALL)

Exclusion criteria

Exclusion criteria: 1. Patients receiving cytotoxic regimens without Pegasparaginase or other diseased status will be excluded. 2. Patients with ALL FAB L3 and blastic crisis of chronic myelogenous leukemia as well as HIV-positive patients were excluded 3. Bilirubin levels more than 34.2 M (2 mg per dL) 4. Creatinine levels more than 178.8 M (2 mg per dL). 5. Patient who have already received the Pegasparaginase will be excluded.

Design outcomes

Primary

MeasureTime frame
Primary The area under the plasma asparaginase activity time profile following administration of the first dose of pegasparaginase. Timepoint: 1.Time point for the primary outcome at 14 days—

Secondary

MeasureTime frame
Secondary 1.Anti-asparaginase antibodies to Cancrinase & Hamsyl 2.Grade 3 or 4 hematological & non-hematological adverse reactions subsequent to administration of cancrinase & Hamsyl 3.Change in amino acids (asparagine, glutamine, aspartate & glutamate) levels following Cancrinase or Hamsyl administration. 4.Asparaginase population pharmacokinetics model Exploratory 1.Differential expression of markers in ALL patients of different risk categories.Timepoint: 1. Antibody levels at day 0, day 10-14, day 21-28 after pegasparaginase administration. 2. Adverse event: from day 0 - day 28 after pegasparaginase administration. 3. Amino acid levels at day 0, day 10-14, day 21-28 after pegasparaginase administration.—

Countries

India

Contacts

Public ContactDr Chetan Dhamne

Tata Memorial Hospital

drchetandhamne@gmail.com9136660746

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026