Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
143 participants
INTERVENTIONAL
2015-12-31
2018-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma
NCT02486952
A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
NCT01205737
A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic Leukemia
NCT01609023
A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma
NCT01649856
A Pharmacokinetic and Pharmacodynamic Study Comparing HLX01 And Rituximab in Patients With CD20-Positive, B-cell Lymphoma
NCT02584920
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MabionCD20
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
Rituximab
375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8.
Doxorubicin
50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle
Vincristine
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
Cyclophosphamide
750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle
prednisone
100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle
MabThera
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
Rituximab
375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8.
Doxorubicin
50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle
Vincristine
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
Cyclophosphamide
750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle
prednisone
100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rituximab
375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8.
Doxorubicin
50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle
Vincristine
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
Cyclophosphamide
750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle
prednisone
100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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;
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mabion SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Clinical Center Banja Luka
Banja Luka, , Bosnia and Herzegovina
University Clinical Center Sarajevo
Sarajevo, , Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, , Bosnia and Herzegovina
General Hospital Zenica
Zenica, , Bosnia and Herzegovina
GH "dr.Josip Bencevic"
Slavonski Brod, , Croatia
CH Merkur
Zagreb, , Croatia
CHC Zagreb
Zagreb, , Croatia
HEMA
Tbilisi, , Georgia
S. Khechinashvili state University clinic
Tbilisi, , Georgia
Medulla - Chemotherapy and Immunotherapy Clinic
Tbilisi, , Georgia
Institut of Oncology, Hematology Department
Chisinau, , Moldova
Wojewódzki Szpital Specjalistyczny w Legnicy, Oddział Hematologiczny
Legnica, , Poland
Samodzielny Publiczny Szpital Kliniczny nr1, Klinika Hematologii i Transplantacji Szpiku
Lublin, , Poland
Szpital Wojewódzki w Opolu, Oddział Hematologii i Onkologii Hematologicznej
Opole, , Poland
MTZ Clinical Research Sp. Z o.o.
Warsaw, , Poland
Clinical Hospital Center Zemun
Belgrade, , Serbia
Clinical Hospital Center Zvezdara
Belgrade, , Serbia
Military Hospital Academy
Belgrade, , Serbia
Public utility "Chernivtsi regional clinical oncology dispensary", Day patient department
Chernivtsi, , Ukraine
Municipal Institution "Dnipropetrovsk City multi-field Clinical Hospital #4", Oncology and medical radiology department
Dnipropetrovsk, , Ukraine
Regional Clinical Hospital of Ivano-Frankivsk, Hematology Department.
Ivano-Frankivsk, , Ukraine
Regional Clinical Oncology Dispensary, Chemotherapy Department
Ivano-Frankivsk, , Ukraine
Kharkiv Regional Clinical Oncology Centre, Deartment of haematology
Kharkiv, , Ukraine
National Institute of Cancer, Department of chemotherapy
Kiev, , Ukraine
Kiev City Clinical Oncological Center, Department of chemotherapy #2
Kiev, , Ukraine
Utility Enterprise "Kirovograd regional oncology dispensary"
Kirovohrad, , Ukraine
Kryvyi Rih Oncology Dispensary, Dnipropetrovsk Highway
Kryvyi Rih, , Ukraine
Volyn' Regional clinical hospital, Haematology Department
Lutsk, , Ukraine
State institution "Institute for haemotopathology and haemotransfusion of National Academy of science of Ukraine
Lviv, , Ukraine
Mykolayiv Region Clinical Hospital, Heamotology department
Mykolayiv, , Ukraine
Poltava regional oncology hospital, heamotherapy department
Poltava, , Ukraine
Regional clinical Hospital named after Novak, Hematology Department
Uzhhorod, , Ukraine
Vinnitsya Regional Clinical Oncology Dispensary, Chemotherapy Department,
Vinnitsya, , Ukraine
Regional Oncology dispensary
Zaporizhzhia, , Ukraine
Zaporizhzhya Regional Clinical Hospital, Deartment of haematology and intensive therapy
Zaporizhzhia, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MabionCD20-002NHL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.