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Completed

NCT Number: NCT02617485

MabionCD20 Compared to MabThera in Lymphoma Patients

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.

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Clinical Center Banja Luka, Banja Luka, Bosnia and Herzegovina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Rituximab

Drug

375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8.

Other names: MabThera®, MabionCD20®

Doxorubicin

Drug

50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle

Other names: Hydroxydaunorubicin

Vincristine

Drug

1.4 mg of vincristine per square meter, up to a maximal dose of 2 mg, administrated IV on day 1 of each chemotherapy cycle

Other names: Oncovine

Cyclophosphamide

Drug

750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle

Prednisone

Drug

100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle

Primary outcomes

  1. Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4])

    Time frame: Baseline to Week 4

    Area under the serum concentration-time curve from time zero (Day 1) to final time point measured after the first administration (Week 1) until Week 4 (AUC(W1-W4)). PK blood samples for this endpoint were drawn at Day 1 (before and after the first infusion), Day 8 ± 1 (7 days after first infusion), Day 15 ± 1 (14 days after first infusion), Day 22 ± 2 (before and after completion of the second infusion).

  2. Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26])

    Time frame: Week 13 to Week 26

    Area under the serum concentration-time curve from time zero to final time point measured from Week 13 until Week 26 (AUC[W13-W26]). PK blood samples for this endpoint were drawn at Day 85 ± 4 (before and after completion of the fifth infusion), Day 106 ± 4 (before and after completion of sixth infusion), Day 127 ± 4 (before and after completion of the seventh infusion), Day 148 ± 4 (before and after completion of the eight infusion), Day 155 ± 4 (one week after last infusion) and Day 176 ± 4 (one month after last infusion).

Secondary outcomes

  1. Ctrough (Before 8th Infusion)

    Time frame: Week 22

    Trough serum concentration measured at the end of a dosing interval at steady state, taken directly before eighth infusion.

  2. Cmax (Post 5th and 8th Infusion)

    Time frame: Week 13 (5th infusion) and Week 22 (8th infusion)

    Maximum serum drug concentration (Cmax) at steady state after the 5th and 8th infusions.

  3. Kel (Post 5th and 8th Infusions)

    Time frame: Week 13 (5th infusion) and Week 22 (8th infusion)

    Elimination Rate Constant at steady stade after the 5th and 8th infusions.

  4. T1/2 (Post 5th and 8th Infusions)

    Time frame: Week 13 to Week 16 and Week 22 to Week 26

    Elimination half-life at steady state after the 5th and 8th infusions.

  5. CLss (Post 5th and 8th Infusions)

    Time frame: Week 13 to Week 16 and Week 22 to Week 26

    Clearance at steady state after the 5th and 8th infusions.

  6. AUC (W1-W26) B-cell

    Time frame: baseline to Week 26

    Area under the serum concentration-time curve of CD19+ B cell counts, measured from the first administration to the final time point at Week 26 (AUC(1-26) B-cell).

  7. AUC (W1-W26)

    Time frame: Week 1 until Week 26

    Area under the serum concentration-time curve measured after the first administration (Week 1) until Week 26 (AUC(1-26))

  8. Efficacy Assessment at Week 26

    Time frame: Week 26

    An efficacy assessment was made after 8 treatment cycles (at Week 26) based on tumour responses classified according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (Cheson et al. 1999). Response was assessed based on clinical, radiologic (CT scan) and pathologic (bone marrow) criteria. Possible efficacy responses were: complete response, partial response, stable disease, and progressive disease. Efficacy reported here includes all patients included in the ITT set.

  9. Adverse Events

    Time frame: from baseline to Week 46

    Percentage of patients with at least one AE in a given category. Data from the entire follow-up are included (Period 1 and Period 2).

Other outcomes

  1. Immunogenicity

    Time frame: from baseline to Week 46

    Percentage of patients with positive ADA or NAb results in a given category. Data pertain to the entire follow-up period (from Baseline to Week 46).

Sponsors and collaborators

Lead sponsor

Mabion SA

Industry

Registry information

Official study title

Randomized, Parallel-group, Double-blind, Comparative Bioequivalence Trial of MabionCD20 Compared to MabThera (Rituximab by Hoffman-La Roche) in Patients With Diffuse Large B-cell Lymphoma

Acronym: MADILYM

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Dec 1, 2015
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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