A multicenter, phase II, open-label study evaluating the benefit of addition of MabThera (rituximab) to standard chemotherapies in patients with previously untreated mantle cell lymphoma. - REMENY
- Conditions
- Mantle cell lymphomaMedDRA version: 8.1Level: LLTClassification code 10061275Term: Mantle cell lymphoma
- Registration Number
- EUCTR2006-004093-27-HU
- Lead Sponsor
- Roche (Hungary) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method