Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukaemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncaspar | Drug | Pegaspargase | ALIAS |
| PEG-rASNase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- PEG-rASNase 500
- description
- 500 U/m2 BSA at day 0
- interventionNames
- Drug: PEG-rASNase
- type
- EXPERIMENTAL
- label
- PEG-rASNase 1000
- description
- 1000 U/m2 BSA at day 0
- interventionNames
- Drug: PEG-rASNase
- type
- EXPERIMENTAL
- label
- PEG-rASNase 1500
- description
- 1500 U/m2 at day 0
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available