CD20 positive Diffuse Large B cell Lymphoma (DLBCL) patients diagnosed according to WHO classification of lymphomas, eligible for rituximab treatment according to MabThera SmPC with life expectance at least 6 months
Conditions
Interventions
Product Name: MabionCD20
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: not applicable
Other descriptive name:
Sponsors
MABION S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histological confirmed CD20 positive diffuse large B cell lymphoma (DLBCL); Patients that had been diagnosed according to the WHO classification; Performance status = 2 on the ECOG/WHO scale, performance status of 3 will be accepted if impairment is caused by DLBCL complications and improvement is expected once therapy is initiated; Patients eligible for rituximab treatment according to MabThera indications; Life expectance at least 6 months; Laboratory values within normal range unless abnormalities are related to lymphoma. A negative serum and urine pregnancy test prior to treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Life expectance less than 6 months; Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment; Rituximab, other anti-CD20 mAb drug treatment, treatment with any cell depleting therapies (e.g., anti-CD4, anti-CD5, anti-CD3, anti-CD19, anti CD11a, anti-CD22, BLys/BAFF) within 1,5 years prior to screening History of other invasive malignancy within 5 years except for localized/in situ carcinomas such as non-melanoma skin cancer or cervical carcinoma in situ; Primary or secondary immunodeficiency; Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine, or gastrointestinal disorders within 5 years prior to screening which, in the Investigator's opinion, would preclude subject participation; Active infections: known active bacterial, viral, fungal, mycobacterial, other infection (including tuberculosis, sepsis, opportunistic infections) but excluding fungal infections of nail beds; III or IV class of the New York Heart Association (NYHA) Classification; Pregnancy and lactation (positive serum pregnancy test for women of child bearing age); Recent vaccination (< 4 weeks prior treatment);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of the study is to demonstrate biosimilarity between MabionCD20 (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients with CD20-positive diffuse large B-cell lymphoma, based on evaluation of primary endpoints.;Secondary Objective: To demonstrate biosimilarity between MabionCD20 (MABION SA) and the reference product MabThera (rituximab by Hoffman-La Roche) in patients with CD20-positive diffuse large B-cell lymphoma based on comparative analysis of the pharmacodynamic parameters, pharmacokinetic parameters, efficacy endpoints, comparative safety and immunogenicity.;Primary end point(s): Area under the plasma concentration-time curve from time zero to final time point (AUC 0-t);Timepoint(s) of evaluation of this end point: measured after the first administration (Week 1) until the second administration at Week 4 and measured at steady state after the fifth administration (Week 13) until Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Drug concentration (AUC) measured after the first administration (Week 1) until Week 26, before 8 administration and after 5 and 8 administration Pharmacodynamic endpoints measured from the first administration until week 26 Efficacy and safety endpoints measured at week 26 Immunogenicity endpoint measured at week 26;Secondary end point(s): Area under the plasma concentration-time curve from time zero to final time point, Pharmacodynamic endpoint (B-cel concentration in blood), efficacy and safety of Investigational Medicinal Product immunogenicity | — |
Countries
Bosnia and Herzegovina, Croatia, Georgia, Moldova, Republic of, Poland, Serbia, Ukraine
Contacts
Public ContactClinical Trials Department
MABION S.A.
Outcome results
None listed