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

Mabion SA0 个研究点目标入组 140 人开始时间: 2014年11月5日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•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

•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);

发起方