MabionCD20 Compared to MabThera in Lymphoma Patients

Last updated: January 11, 2023
Sponsor: Mabion SA
Overall Status: Completed

Phase

3

Condition

Lymphoma

Lymphoma, B-cell

Hematologic Cancer

Treatment

Doxorubicin

Vincristine

prednisone

Clinical Study ID

NCT02617485
MabionCD20-002NHL
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Patients with histological confirmed CD20 (cluster of differentiation 20) positivediffuse 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 (worldHealth Organization) scale, performance status of 3 will be accepted if impairment iscaused by DLBCL complications and improvement is expected once therapy is initiated;

Exclusion

Exclusion Criteria:

  1. Life expectance less than 6 months;
  2. Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonaltherapy for treatment of lymphoma within 28 days prior to treatment;
  3. Rituximab, other anti-CD20 mAb (Monoclonal Antibodies) drug treatment, treatment withany 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 activatingfactor) within 1,5 years before screening;

Study Design

Total Participants: 143
Treatment Group(s): 5
Primary Treatment: Doxorubicin
Phase: 3
Study Start date:
December 01, 2015
Estimated Completion Date:
January 31, 2018

Study 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.

Connect with a study center

  • University Clinical Center Banja Luka

    Banja Luka, 78 000
    Bosnia and Herzegovina

    Site Not Available

  • University Clinical Center Sarajevo

    Sarajevo, 71 000
    Bosnia and Herzegovina

    Site Not Available

  • University Clinical Center Tuzla

    Tuzla, 75 000
    Bosnia and Herzegovina

    Site Not Available

  • General Hospital Zenica

    Zenica, 72 000
    Bosnia and Herzegovina

    Site Not Available

  • GH "dr.Josip Bencevic"

    Slavonski Brod, 35000
    Croatia

    Site Not Available

  • CH Merkur

    Zagreb, 10000
    Croatia

    Site Not Available

  • CHC Zagreb

    Zagreb, 10000
    Croatia

    Site Not Available

  • HEMA

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Medulla - Chemotherapy and Immunotherapy Clinic

    Tbilisi, 0186
    Georgia

    Site Not Available

  • S. Khechinashvili state University clinic

    Tbilisi, 0179
    Georgia

    Site Not Available

  • Medulla - Chemotherapy and Immunotherapy Clinic

    Tibilisi, 0186
    Georgia

    Site Not Available

  • "Semmelweis Egyetem I. Belgyógyászati Klinika Hematológia"

    Budapest, 1083
    Hungary

    Site Not Available

  • "Somogy Megyei Kaposi Mór Oktató Kórház Hematológiai Osztály"

    Kaposvár, 7400
    Hungary

    Site Not Available

  • "Pécsi Tudományegyetem, Intézeti Gyógyszertár"

    Pécs, 7624
    Hungary

    Site Not Available

  • "Fejér Megyei Szent György Egyetemi Oktató Kórház Intézeti Gyógyszertár"

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • Institut of Oncology, Hematology Department

    Chisinau, 2025
    Moldova, Republic of

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny w Legnicy, Oddział Hematologiczny

    Legnica, 59-220
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr1, Klinika Hematologii i Transplantacji Szpiku

    Lublin, 20-081
    Poland

    Site Not Available

  • Szpital Wojewódzki w Opolu, Oddział Hematologii i Onkologii Hematologicznej

    Opole, 45-061
    Poland

    Site Not Available

  • MTZ Clinical Research Sp. Z o.o.

    Warsaw, 02-106
    Poland

    Site Not Available

  • Clinical Emergency County Hospital Brasov

    Brasov, 500365
    Romania

    Site Not Available

  • Coltea Clinical Hospital

    Bucuresti, 030171
    Romania

    Site Not Available

  • Institutul Regional de Oncologie Iasi

    Lasi, 700483
    Romania

    Site Not Available

  • Oncomed

    Timisoara, 300239
    Romania

    Site Not Available

  • Clinical Hospital Center Zemun

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000
    Serbia

    Site Not Available

  • Military Hospital Academy

    Belgrade, 11000
    Serbia

    Site Not Available

  • Public utility "Chernivtsi regional clinical oncology dispensary", Day patient department

    Chernivtsi, 58013
    Ukraine

    Site Not Available

  • Municipal Institution "Dnipropetrovsk City multi-field Clinical Hospital #4", Oncology and medical radiology department

    Dnipropetrovsk, 49102
    Ukraine

    Site Not Available

  • Regional Clinical Hospital of Ivano-Frankivsk, Hematology Department.

    Ivano-Frankivsk, 76008
    Ukraine

    Site Not Available

  • Regional Clinical Oncology Dispensary, Chemotherapy Department

    Ivano-Frankivsk, 76018
    Ukraine

    Site Not Available

  • Kharkiv Regional Clinical Oncology Centre, Deartment of haematology

    Kharkiv, 61070
    Ukraine

    Site Not Available

  • Kiev City Clinical Oncological Center, Department of chemotherapy #2

    Kiev, 03115
    Ukraine

    Site Not Available

  • National Institute of Cancer, Department of chemotherapy

    Kiev, 03022
    Ukraine

    Site Not Available

  • Utility Enterprise "Kirovograd regional oncology dispensary"

    Kirovograd, 25011
    Ukraine

    Site Not Available

  • Utility Enterprise "Kirovograd regional oncology dispensary"

    Kirovohrad, 25011
    Ukraine

    Site Not Available

  • Kryvyi Rih Oncology Dispensary, Dnipropetrovsk Highway

    Krivoy Rog, 50048
    Ukraine

    Site Not Available

  • Kryvyi Rih Oncology Dispensary, Dnipropetrovsk Highway

    Kryvyi Rih, 50048
    Ukraine

    Site Not Available

  • Volyn' Regional clinical hospital, Haematology Department

    Lutsk, 45634
    Ukraine

    Site Not Available

  • State institution "Institute for haemotopathology and haemotransfusion of National Academy of science of Ukraine

    Lviv, 79044
    Ukraine

    Site Not Available

  • Mykolayiv Region Clinical Hospital, Heamotology department

    Mykolayiv, 54058
    Ukraine

    Site Not Available

  • Poltava regional oncology hospital, heamotherapy department

    Poltava, 36011
    Ukraine

    Site Not Available

  • Regional clinical Hospital named after Novak, Hematology Department

    Uzhgorod, 88000
    Ukraine

    Site Not Available

  • Vinnitsya Regional Clinical Oncology Dispensary, Chemotherapy Department,

    Vinnitsya, 21029
    Ukraine

    Site Not Available

  • Regional Oncology dispensary

    Zaporizhzhia, 69040
    Ukraine

    Site Not Available

  • Zaporizhzhya Regional Clinical Hospital, Deartment of haematology and intensive therapy

    Zaporizhzhia, 69600
    Ukraine

    Site Not Available

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