Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia

A Randomized, Multi-centre, Parallel-group, Open Label, Oncaspar® Controlled Dose Ranging Trial of Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01251809

Enrollment

Registered

2010-12-02

Start date

2011-01-31

Completion date

2013-05-31

Last updated

2013-05-20

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

Conditions

Acute Lymphoblastic Leukaemia

Keywords

Asparaginase, ALL

Brief summary

This is an assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for determining specific asparaginase doses to yield various durations of L-asparagine (ASN) depletion which are required within different treatment phases of ALL therapy.

Interventions

DRUGOncaspar

2000 U/m2 BSA, single infusion

DRUGPEG-rASNase

500, 1000 or 1500 U/m2 BSA single infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Previously untreated acute lymphoblastic leukaemia (pro-B, common, pre-B, early T, thymic T, mature T) * Age 18 years - 55 years * Treatment according to German Multicenter Trials for adult Acute Lymphoblastic Leukaemia (GMALL) 07/2003 protocol or subsequent GMALL protocols for patients with de novo ALL * Written informed consent * Women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception * Negative pregnancy test for women of child-bearing potential

Exclusion criteria

* Patients with Philadelphia chromosome (BCR-ABL) positive ALL * Severe comorbidity or leukaemia-associated complications * Known hypersensitivity to asparaginase * History of severe pancreatitis * History of thrombosis or pulmonary embolism * Pre-existing clinically relevant coagulopathy * Liver dysfunction (e.g. acute or current hepatitis, alcohol or drug abuse) or history of clinically relevant liver disease * Bilirubin \> 1.5 x Upper Limit Norm (ULN) * Other current malignancies * Severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent * Body mass index \> 30 kg/m² * Known pregnancy, breast feeding

Design outcomes

Primary

Measure	Time frame	Description
To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.	3 weeks	To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.

Secondary

Measure	Time frame	Description
Comparing of treatment arms	62 days	-the rate of patients with asparagine depletion

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026