MabionCD20 Compared to MabThera in Lymphoma Patients (MADILYM)

Mabion

Status and phase: Completed; Phase 3

Conditions: Diffuse Large B-Cell Lymphoma

Treatments: Drug: prednisone; Drug: Cyclophosphamide; Drug: Rituximab; Drug: Vincristine; Drug: Doxorubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02617485

MabionCD20-002NHL

Details and patient eligibility

About

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.

Full description

Patients who meet criteria for participation in this study receive 8 intravenous infusions of MabionCD20® or MabThera® 21 days interval in combination with standard dosage regimen of CHOP. The duration of the study is 12 months. The treatment and observation period will last 26 weeks starting from Day 1, until Week 26 - one month after last IMP infusion.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with histological confirmed CD20 (cluster of differentiation 20) positive diffuse large B cell lymphoma (DLBCL)
2. Patients that had been diagnosed according to the WHO classification;
3. 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

1. Life expectance less than 6 months;
2. Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment;
3. 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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143 participants in 2 patient groups

MabionCD20

Experimental group

Description:

A course of MabionCD20 consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles. Intervention: Drug: Rituximab

Treatment:

Drug: Cyclophosphamide

Drug: Vincristine

Drug: Doxorubicin

Drug: prednisone

Drug: Rituximab

MabThera

Active Comparator group

Description:

A course of MabThera consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles. Intervention: Drug: Rituximab

Treatment:

Drug: Cyclophosphamide

Drug: Vincristine

Drug: Doxorubicin

Drug: prednisone

Drug: Rituximab