Comparison of drugs used in the treatment of blood cancer in children.Escherichia coli asparaginase vs pegylated asparaginase

Comparison of efficacy and safety of E.coli asparaginase against pegylated asparaginase in patients with childhood lymphoblastic leukemia: A population pharmacokinetic-pharmacodynamic approach

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/06/019520

Enrollment

Registered

2019-06-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: PEG asparaginase: PEG asparaginase 1000 U/ mÂ² Intramuscular ,once daily on days 9 and 23 in induction phase of patients with acute lymphoblastic leukemia.Total 2 doses Control Interven

Eligibility

Inclusion criteria

Inclusion criteria: a)Patients of 1-18 years of age undergoing induction phase chemotherapy for newly diagnosed acute lymphoblastic leukemia. b)Patients whose parent/guardian are willing to give consent and children willing to give assent.

Exclusion criteria

Exclusion criteria: a)Cases of ALL less than 1 year of age b)Relapse cases of ALL c)Prior history of hepatitis d)Prior history of pancreatitis e)Prior history of tuberculosis f)Prior history of allergy to any of treatment medication used in the management of ALL.

Design outcomes

Primary

Measure	Time frame
Determination of the asparagine levels of ALL patients taking asparaginase at the end of the study period (induction phase)Timepoint: at 33rd day of induction phase	—

Secondary

Measure	Time frame
1)Determination of asparagine levels at various time points as per the formulation provided. 2)Determination of PK-PD relationship for native E. coli asparaginase and pegylated asparaginase during the induction phase of chemotherapy.Timepoint: E.coli asparaginase group-immediately prior to the drug administration, 20 minutes, 1hour, 4 hours, 24 hours and at 72 hours post the administration of the drug.PEG-asparaginase group immediately prior to the drug administration, 24 hours, 48 hours, 168 hours (at the end of 7 days), 336 hours (at the end of 14 days) post administration of the drug	—

Measure

Time frame

1)Determination of asparagine levels at various time points as per the formulation provided. 2)Determination of PK-PD relationship for native E. coli asparaginase and pegylated asparaginase during the induction phase of chemotherapy.Timepoint: E.coli asparaginase group-immediately prior to the drug administration, 20 minutes, 1hour, 4 hours, 24 hours and at 72 hours post the administration of the drug.PEG-asparaginase group immediately prior to the drug administration, 24 hours, 48 hours, 168 hours (at the end of 7 days), 336 hours (at the end of 14 days) post administration of the drug

—

Countries

India

Contacts

Public ContactDr SujithaS

All India Institute of Medical Sciences,Bhubaneswar

anandsrinivasan@aiimsbhubaneswar.edu.in9216996577

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 19, 2026