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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02617485 |
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Date of registration:
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12/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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MabionCD20® Compared to MabThera® in Lymphoma Patients
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Scientific title:
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Randomized, Parallel-group, Double-blind, Comparative Bioequivalence Trial of MabionCD20 (Mabion SA) Compared to MabThera (Rituximab by Hoffman-La Roche) in Patients With Diffuse Large B-cell Lymphoma |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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143 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02617485 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Bosnia and Herzegovina
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Croatia
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Georgia
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Hungary
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Moldova, Republic of
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Poland
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Romania
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Serbia
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Ukraine
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Key inclusion & exclusion criteria
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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;
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diffuse Large B-Cell Lymphoma
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Intervention(s)
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Drug: Cyclophosphamide
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Drug: prednisone
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Drug: Rituximab
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Drug: Vincristine
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Drug: Doxorubicin
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Primary Outcome(s)
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Area under the plasma concentration- time curve from time zero to final time point
[Time Frame: 26 weeks]
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Area under the plasma concentration- time curve from time zero to final time point
[Time Frame: 4 weeks]
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Secondary ID(s)
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MabionCD20-002NHL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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