The comparative clinical trial with use of two biologic products: MabionCD20 and MabThera in lymphoma patients

Phase 1

• Conditions: 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]

• Registration Number: EUCTR2013-005506-56-PL
• Lead Sponsor: MABION S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-17
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

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;
Laboratory values within normal range unless abnormalities are related to lymphoma.
A negative serum and 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;
Rituximab, other anti-CD20 mAb drug treatment, treatment with any cell depleting therapies (e.g., anti-CD4, anti-CD5, anti-CD3, anti-CD19, anti CD11a, anti-CD22, BLys/BAFF) within 1,5 years prior to screening
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 within 5 years prior to screening 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 and lactation (positive serum pregnancy test for women of child bearing age);
Recent vaccination (< 4 weeks prior treatment);

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified