Acute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in the bone marrow leads to suppression of normal haematopoiesis as well as disseminated infiltration of organs and release of blasts into periphal blood. MedDRA version: 9.1 Level: LLT Classification code 10000844 Term: Acute lymphoblastic leukaemia
Conditions
Interventions
Product Name: r-L-asparaginase (Recombinant L-Asparaginase)
Product Code: MC0707
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: no INN
CAS Number: 9015-68-3
Current Sponsor
Sponsors
medac Gesellschaft für klinische Spezialpräparate mbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 cyto¬chemistry 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulines or t(8;14) and breakpoint as in B-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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the number of patients with hypersensitivity reactions to rASNase.;Secondary Objective: - ASNase activity in serum directly before rASNase infusions 1, 2, 4, and 6 during induction treatment, - Concentrations of the amino acids asparagine (ASN), aspartic acid (ASP), glutamine (GLN), and glutamic acid (GLU) in serum directly before rASNase infusions 1, 2, 4, and 6 during induction treatment, -Anti-ASNase antibodies in serum directly before rASNase infusions 1, 2, 4, and 6 during induction treatment, - CR rate and MRD status after induction treatment phase A, - Relapse rate, relapse-free survival and event-free survival at end of follow-up, - Number of patients who could complete their full course of rASNase treatment, - Incidence and severity of adverse events. ;Primary end point(s): This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase (rASNase) for first-line treatment of infants (< 1 year of age at diagnosis) with de novo acute lymphoblastic leukaemia Primary objective: To determine the number of patients with hypersensitivity reactions to rASNase. | — |
Countries
Netherlands
Outcome results
None listed