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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


Phase 1/Phase 2
18 Years
55 Years
Not Enrolling
Both
Acute Lymphoblastic Leukaemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

3 weeks

Safety Issue:

No

Principal Investigator

Nicola Gökbuget, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitätsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

MC-PEGASP.1/adults

NCT ID:

NCT01251809

Start Date:

January 2011

Completion Date:

May 2013

Related Keywords:

  • Acute Lymphoblastic Leukaemia
  • Asparaginase
  • ALL
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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