Phase 3
N=140
MabionCD20 Compared to MabThera in Lymphoma Patients
Diffuse Large B-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02617485 ↗Enrolled (actual)
140
Serious AEs
17.1%
Results posted
Oct 2023
Primary outcome: Primary: Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4]) — 1559.51; 1509.79 (μg*day)/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rituximab (Drug); Doxorubicin (Drug); Vincristine (Drug); Cyclophosphamide (Drug); prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mabion SA
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4]) |
1559.51; 1509.79 | — |
| PRIMARY Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26]) |
16498.9; 15647.4 | — |
| SECONDARY Ctrough (Before 8th Infusion) |
102.246; 90.61 | — |
| SECONDARY Cmax (Post 5th and 8th Infusion) |
273.356; 266.439; 296.784; 296.462 | — |
| SECONDARY Kel (Post 5th and 8th Infusions) |
0.05663; 0.05418; 0.04335; 0.04379 | — |
| SECONDARY T1/2 (Post 5th and 8th Infusions) |
14.801; 15.217; 18.301; 16.997 | — |
| SECONDARY CLss (Post 5th and 8th Infusions) |
198.701; 206.905; 179.168; 191.272 | — |
| SECONDARY AUC (W1-W26) B-cell |
3395.82; 10476.2 | — |
| SECONDARY AUC (W1-W26) |
28413.6; 26955.3 | — |
| SECONDARY Efficacy Assessment at Week 26 |
34; 14; 42; 18; 10; 4 | — |
| SECONDARY Adverse Events |
71.0; 67.5; 71.0; 65.0; 19.0; 12.5 | — |
Summary
The aim of the study is to demonstrate the high level of 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.
Eligibility Criteria
Inclusion Criteria
- Patients with histological confirmed CD20 (cluster of differentiation 20) positive diffuse large B cell lymphoma (DLBCL)
- Patients that had been diagnosed according to the WHO classification;
- Performance status ≤ 2 on the ECOG (Eastern Cooperative Oncology Group) / WHO (world Health Organization) scale, performance status of 3 will be accepted if impairment is caused by DLBCL complications and improvement is expected once therapy is initiated;
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 (Monoclonal Antibodies) drug treatment, treatment with any cell depleting therapies - e.g., anti-CD4 (cluster of differentiation 4) anti-CD5 (cluster of differentiation 5), anti-CD3 (cluster of differentiation 3), anti-CD19 (cluster of differentiation 19), anti CD11 (cluster of differentiation 11), anti-CD22 (cluster of differentiation 11), BLys/BAFF (B Lymphocyte Stimulator/B-cell activating factor) within 1,5 years before screening;
Data sourced from ClinicalTrials.gov (NCT02617485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.