World Health Organization site
Skip Navigation Links

Main
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: EUCTR
Last refreshed on: 30 June 2019
Main ID:  EUCTR2013-005506-56-HR
Date of registration: 05/11/2014
Prospective Registration: No
Primary sponsor: Mabion SA
Public title: The comparative clinical trial with use of two biologic products: MabionCD20 and MabThera in lymphoma patients
Scientific title: 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: 12/09/2014
Target sample size: 140
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005506-56
Study type:  Interventional clinical trial of medicinal product
Study design: 
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
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Bosnia and Herzegovina Bulgaria Croatia Georgia Hungary Moldova, Republic of Poland Serbia
Contacts
Name: Clinical Trial Coordination Unit   
Address:  17 Fabryczna Street 90-344 Lódz Poland
Telephone: +48422908210
Email: m.matusiak@mabion.eu
Affiliation:  Mabion SA
Name: Clinical Trial Coordination Unit   
Address:  17 Fabryczna Street 90-344 Lódz Poland
Telephone: +48422908210
Email: m.matusiak@mabion.eu
Affiliation:  Mabion SA
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
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
Therapeutic area: Diseases [C] - Cancer [C04]
Intervention(s)

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

Primary Outcome(s)
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.
Primary end point(s): Area under the plasma concentration-time curve from time zero to final time point (AUC 0-t)
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
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.
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: measured after the first administration (Week 1) until Week 26
Secondary end point(s): Area under the plasma concentration-time curve from time zero to final time point
Secondary ID(s)
2013-005506-56-PL
MabionCD20-001NHL
Source(s) of Monetary Support
Mabion SA
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history