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 (Recombinat 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 GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Previously untreated T-lineage or precursor B-lineage ALL - Patients must have morphological proof of ALL and diagnosis must be made from bone marrow morphology with ? 25% blasts - Age 1 year to 18 years - Written informed consent - Treatment according to DCOG ALL 10 protocol Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Mature B-lineage ALL - Patients with secondary ALL - Known allergy to any ASNase preparation - General health status according to Karnofsky / Lansky score 50 µmol/L; SGOT/SGPT > 10 x ULN) - Other current malignancies - Pregnancy (planned or existent), breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the rate of patients with complete asparaginase (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac with respect to this parameter.;Secondary Objective: Incidence of patients with hypersensitivity reactions to the first dose of ASNase Incidence of predefined ASNase-typical adverse events observed during induction treatment in both treatment arms Rate of complete ASN depletion in CSF at day 33 Trough levels of ASNase activity in serum just before ASNase infusions 2, 4, 6, and 8 during induction treatment ASNase activity levels in CSF during induction treatment phase A Concentrations of the amino acids ASN, aspartic acid (ASP), glutamine (GLN), and glutamic acid (GLU) in serum and CSF at defined time points during induction treatment Trough levels of ASNase activity and ASN, ASP, GLN, and GLU levels in serum at defined time points during post-induction treatment Anti-ASNase antibodies in serum during repeated administration of ASNase CR rate and MRD status after induction treatment phase A To assess the incedence of edverse events in both tratment arms Further information secondary objectives see Study Protocol ;Primary end point(s): Number of patients with complete ASN depletion in serum during induction treatment. Complete ASN depletion is defined as more then 95% reduction of ASN serum levels compared to the baseline value at all measured time points (always before ASNase infusion 2,4,6,8). If a treatment delay between two consecutive ASNase infusions of more than 4 days has occurred, the next scheduled sample for ASN depletion will not be counted. A patient is evaluable for the primary endpoint if ASN levels are available from at least 3 of the 4 scheduled time points. If a baseline ASN value for a special patient is not available for any reason, an average ASN baseline level will be calculated from all patients and taken as reference. If an ASN value befor | — |
Countries
Netherlands
Outcome results
None listed