Efficacy and safety of recombinant asparaginase in infants ( < 1 year) with previously untreated acute lymphoblastic leukemia, a phase II clinical trial

Phase 2

Completed

Conditions: acute lymphoblastic leukemia in infants
10024324

Registration Number: NL-OMON33689

Lead Sponsor: Medac

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

- Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria
- Morphological verification of the diagnosis, confirmed with cytochemistry and immunophenotyping. In case a bone marrow aspiration results in a *dry tap*, a trephine biopsy is advised unless it is possible to confirm the diagnosis by peripheral blood examination.
- Age < 1 year at diagnosis
- Written informed consent of the parents or other legally authorised guardians of the patient
- Treatment according to protocol INTERFANT 06 (EudraCT Number 2005-004599-19)

Exclusion Criteria

- Mature B-lineage ALL
-The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells (if these data are not known, the patient is eligible)
- Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible.
- Known allergy to any ASNase preparation
- Pre-existing known coagulopathy (e.g. haemophilia)
- Pre-existing pancreatitis
- Liver insufficiency (bilirubin > 50 µmol/L; SGOT/SGPT > 10 x the upper limit of normal).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the number of patients with hypersensitivity reactions to rASNase. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- ASNase activity in serum just before rASNase infusions 1, 2, 4, and 6 during<br /><br>induction treatment,<br /><br>- Concentrations of the amino acids asparagine (ASN), aspartic acid (ASP),<br /><br>glutamine (GLN), and glutamic acid (GLU) in serum at defined time points during<br /><br>induction treatment,<br /><br>- Anti-ASNase antibodies in serum during repeated administration of rASNase,<br /><br>- CR rate and MRD status after induction treatment phase A,<br /><br>- Relapse rate, relapse-free survival and event-free survival at end of study,<br /><br>- Number of patients who could complete their full course of rASNase treatment,<br /><br>- Incidence and severity of adverse events. </p><br>