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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. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2013-005506-56-HR |
Date of registration:
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05/11/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The comparative clinical trial with use of two biologic products: MabionCD20 and 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 - MADILYM |
Date of first enrolment:
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12/09/2014 |
Target sample size:
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140 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005506-56 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: MabThera Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Bosnia and Herzegovina
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Bulgaria
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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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Serbia
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Contacts
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Name:
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Clinical Trial Coordination Unit
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Address:
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17 Fabryczna Street
90-344
Lódz
Poland |
Telephone:
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+48422908210 |
Email:
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m.matusiak@mabion.eu |
Affiliation:
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Mabion SA |
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Name:
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Clinical Trial Coordination Unit
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Address:
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17 Fabryczna Street
90-344
Lódz
Poland |
Telephone:
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+48422908210 |
Email:
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m.matusiak@mabion.eu |
Affiliation:
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Mabion SA |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with histological confirmed CD20 positive diffuse large B cell lymphoma (DLBCL); Patients that had been diagnosed according to the WHO classification; Performance status = 2 on the ECOG/WHO scale, performance status of 3 will be accepted if impairment is caused by DLBCL complications and improvement is expected once therapy is initiated; Patients eligible for rituximab treatment according to MabThera indications. Life expectance at least 6 months; No prior immunotherapy for DLBCL; Laboratory values within normal range unless abnormalities are related to lymphoma. A negative serum or urine pregnancy test prior to treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
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; Prior rituximab, other anti-CD20 mAb drug treatment, previous treatment with any cell depleting therapies (e.g., anti-CD4, anti-CD5, anti-CD3, anti-CD19, anti CD11a, anti-CD22, BLys/BAFF). Secondary lymphoma after previous chemotherapy or radiotherapy; History of other invasive malignancy within 5 years except for localized/in situ carcinomas such as non-melanoma skin cancer or cervical carcinoma in situ; Primary or secondary immunodeficiency; Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine, or gastrointestinal disorders which, in the Investigator's opinion, would preclude subject participation; Active infections: known active bacterial, viral, fungal, mycobacterial, other infection (including tuberculosis, sepsis, opportunistic infections) but excluding fungal infections of nail beds; III or IV class of the New York Heart Association (NYHA) Classification; Pregnancy or lactation (negative serum pregnancy test for women of child bearing age); Recent vaccination (< 4 weeks prior treatment);
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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CD20 positive Diffuse Large B cell Lymphoma (DLBCL) patients diagnosed according to WHO classification of lymphomas, eligible for rituximab treatment according to MabThera SmPC with life expectance at least 6 months
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: MabionCD20 (biosimilar to rituximab) Product Code: CD20 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: rituximab Current Sponsor code: L01X C02 Other descriptive name: MOUSE-HUMAN CHIMERIC MONOCLONAL ANTI-GD2 IGG1 ANTIBODY Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 375-
Trade Name: MabThera Pharmaceutical Form: Concentrate for solution for infusion
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Primary Outcome(s)
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Secondary Objective: To demonstrate 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 based on comparative analysis of the pharmacodynamic parameters, pharmacokinetic parameters, the percentage of patients achieving the efficacy endpoints, comparative safety and immunogenicity.
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Primary end point(s): Area under the plasma concentration-time curve from time zero to final time point (AUC 0-t)
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Timepoint(s) of evaluation of this end point: measured after the first administration (Week 1) until the second administration at Week 4 and measured at steady state after the fifth administration (Week 13) until Week 26
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Main Objective: Primary objective of the study is to demonstrate 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, based on the percentage of patients achieving the primary pharmacokinetic endpoints.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: measured after the first administration (Week 1) until Week 26
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Secondary end point(s): Area under the plasma concentration-time curve from time zero to final time point
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Secondary ID(s)
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2013-005506-56-PL
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MabionCD20-001NHL
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Source(s) of Monetary Support
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Mabion SA
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Ethics review
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Status: Approved
Approval date:
Contact:
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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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