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MabionCD20 Compared to MabThera in Lymphoma Patients (MADILYM)

M

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

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

Trial documents
2

Trial contacts and locations

35

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Data sourced from clinicaltrials.gov

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