Mantle cell lymphoma MedDRA version: 8.1 Level: LLT Classification code 10061275 Term: Mantle cell lymphoma
Conditions
Interventions
Trade Name: MabThera 100mg and 500mg
Product Name: MabThera
Product Code: RO 0452294
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: rituximab
Current Sponsor code: RO0
Sponsors
Roche (Hungary) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written and signed informed consent according to ICH/EU GCP and national/local regulations 2. Male or female patients 3. Age >18 years. 4. Histologically proven mantle cell lymphoma: MCL must be proven by a histological examination of representative material (e.g. lymph node or bone marrow) within 4 weeks before induction of treatment. Cyclin D1 posititivity or t(11;14)(q13;q32) is desirable but not essential for diagnosis. 5. Material (lymph node or bone marrow biopsy) must be available for possible farther review 6. Previously untreated disease at stage II, III and IV, requiring therapy 7. Life expectancy of at least 6 months 8. Pre-study performance status ECOG 0, 1 or 2 (see Appendix) 9. Women of childbearing potential must agree to follow accepted birth control methods during the trial 10. Men must agree to follow accepted birth control methods during the trial in order not to father a child 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity reaction to rituximab, known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies, or standard chemotherapy compounds or incorporated substances 2. Previous treatment with rituximab 3. Platelet count < 100 x 103 /mm3, WBC < 3.0 x 103 /mm3, unless clearly related to MCL bone marrow infiltration 4. Patients with stage I disease 5. Patients with central nervous system involvement 6. Patients with a history of autoimmune hemolytic anemia or autoimmune thrombocytopenia 7. Active malignancy other than MCL within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, sqamous cell carcinoma of the skin, or in situ malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective • To evaluate the benefit of adding MabThera® (rituximab) to chemotherapy of MCL patients by measuring induction of response (CR(u), PR) ;Secondary Objective: Secondary objectives • To assess event driven survival endpoints (EFS, PFS) • To evaluate time to treatment failure (TTF) • To describe the safety and tolerability profile of MabThera® (rituximab) containing first line regimen in patients with MCL;Primary end point(s): 1. CR requires the following: • Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. • All lymph nodes and nodal masses must have regressed to normal size (1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to 1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD). • The spleen, if considered to be enlarged before therapy based on a CT scan, must have regressed in size and must not be palpable on physical examination. However, no normal size can be specified because of the difficulties in accurately evaluating splenic and hepatic size. Any macroscopic nodules in any organs detectable on imaging techniques- attributed to be lymphoma-should no longer be present. Similarly, other organs considered to be enlarged before therapy due to involvement by lymphoma, such as liver and kidneys, must have decreased in size. • If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeated bone marrow biopsy of the same site. The sample in which this determination is made must be adequate (>20 mm biopsy core). Flow cytomtetric, molecular, or cytogenetic studies are not considered part of routine assessment to d | — |
Countries
Hungary
Outcome results
None listed