Clinical trial NCT02617485: MabionCD20 Compared to MabThera in Lymphoma Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Mabion SA
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4])
timeFrame: Baseline to Week 4
measure: Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26])
timeFrame: Week 13 to Week 26
Secondary outcomes:
measure: Ctrough (Before 8th Infusion)
timeFrame: Week 22
measure: Cmax (Post 5th and 8th Infusion)
timeFrame: Week 13 (5th infusion) and Week 22 (8th infusion)
measure: Kel (Post 5th and 8th Infusions)
timeFrame: Week 13 (5th infusion) and Week 22 (8th infusion)
measure: T1/2 (Post 5th and 8th Infusions)
timeFrame: Week 13 to Week 16 and Week 22 to Week 26
measure: CLss (Post 5th and 8th Infusions)
timeFrame: Week 13 to Week 16 and Week 22 to Week 26
measure: AUC (W1-W26) B-cell
timeFrame: baseline to Week 26
measure: AUC (W1-W26)
timeFrame: Week 1 until Week 26
measure: Efficacy Assessment at Week 26
timeFrame: Week 26
measure: Adverse Events
timeFrame: from baseline to Week 46
Other outcomes:
measure: Immunogenicity
timeFrame: from baseline to Week 46
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center Banja Luka
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinical Center Sarajevo
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Center Tuzla
city: Zenica
country: Bosnia and Herzegovina
facility: General Hospital Zenica
city: Slavonski Brod
country: Croatia
facility: GH "dr.Josip Bencevic"
city: Zagreb
country: Croatia
facility: CH Merkur
city: Zagreb
country: Croatia
facility: CHC Zagreb
city: Tbilisi
country: Georgia
facility: HEMA
city: Tbilisi
country: Georgia
facility: S. Khechinashvili state University clinic
city: Tbilisi
country: Georgia
facility: Medulla - Chemotherapy and Immunotherapy Clinic
city: Chisinau
country: Moldova, Republic of
facility: Institut of Oncology, Hematology Department
city: Legnica
country: Poland
facility: Wojewódzki Szpital Specjalistyczny w Legnicy, Oddział Hematologiczny
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr1, Klinika Hematologii i Transplantacji Szpiku
city: Opole
country: Poland
facility: Szpital Wojewódzki w Opolu, Oddział Hematologii i Onkologii Hematologicznej
city: Warsaw
country: Poland
facility: MTZ Clinical Research Sp. Z o.o.
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zemun
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
city: Belgrade
country: Serbia
facility: Military Hospital Academy
city: Chernivtsi
country: Ukraine
facility: Public utility "Chernivtsi regional clinical oncology dispensary", Day patient department
city: Dnipropetrovsk
country: Ukraine
facility: Municipal Institution "Dnipropetrovsk City multi-field Clinical Hospital #4", Oncology and medical radiology department
city: Ivano-Frankivsk
country: Ukraine
facility: Regional Clinical Hospital of Ivano-Frankivsk, Hematology Department.
city: Ivano-Frankivsk
country: Ukraine
facility: Regional Clinical Oncology Dispensary, Chemotherapy Department
city: Kharkiv
country: Ukraine
facility: Kharkiv Regional Clinical Oncology Centre, Deartment of haematology
city: Kiev
country: Ukraine
facility: National Institute of Cancer, Department of chemotherapy
city: Kiev
country: Ukraine
facility: Kiev City Clinical Oncological Center, Department of chemotherapy #2
city: Kirovohrad
country: Ukraine
facility: Utility Enterprise "Kirovograd regional oncology dispensary"
city: Kryvyi Rih
country: Ukraine
facility: Kryvyi Rih Oncology Dispensary, Dnipropetrovsk Highway
city: Lutsk
country: Ukraine
facility: Volyn' Regional clinical hospital, Haematology Department
city: Lviv
country: Ukraine
facility: State institution "Institute for haemotopathology and haemotransfusion of National Academy of science of Ukraine
city: Mykolayiv
country: Ukraine
facility: Mykolayiv Region Clinical Hospital, Heamotology department
city: Poltava
country: Ukraine
facility: Poltava regional oncology hospital, heamotherapy department
city: Uzhgorod
country: Ukraine
facility: Regional clinical Hospital named after Novak, Hematology Department
city: Vinnitsya
country: Ukraine
facility: Vinnitsya Regional Clinical Oncology Dispensary, Chemotherapy Department,
city: Zaporizhzhia
country: Ukraine
facility: Regional Oncology dispensary
city: Zaporizhzhia
country: Ukraine
facility: Zaporizhzhya Regional Clinical Hospital, Deartment of haematology and intensive therapy
Study officials:
References: