Mantle Cell Lymphoma
Conditions
Interventions
Product Name: Mabthera
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 375
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a)Patients must be 18 years of age or older b)Confirmed diagnosis of MCL: c)MCL must be proven by a histological examination of representative material (lymph nodes or bone marrow) Together with a typical immunophenotype CD5+, CD23-, sIgM, cyclin D1 nuclear positivity is desirable but not essential. d)Central review of histology will be performed on diagnostic material (see 17.0) e)Previously untreated disease at any stage requiring therapy in the opinion of the treating physician f)No previous chemotherapy g)Life expectancy of at least 3 months h)Signed and dated informed consent 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: a) Known serological positivity for HBV, HCV or HIV. b)No pregnant or lactating female patients (female patients or female partners of male patients of childbearing potential should apply appropriate contraceptive precautions during the entire treatment period). c) Life expectancy severely limited by other illness. d)Concomitant uncontrolled serious medical conditions e)Severe impairment of renal or liver function (alkaline phosphatase/bilirubin or creatinine > 2.5 times upper limit of normal) not related to lymphoma. f) Known hypersensitivity to murine proteins. g)Renal failure (creatinine clearance < 30 ml/min) h)Previous malignancy in the last 5 years, excluding non-melanoma skin tumour or curatively resected in situ carcinoma of the uterine cervix i)Patients with a history of a psychological illness or condition that in the opinion of the investigator may adversely affect compliance with study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the overall survival of patients treated with cyclophoshamide and fludarabine in comparison to rituximab, cyclophosphamide and fludarabine.;Secondary Objective: To assess progression free survival, toxicity and tumour response.;Primary end point(s): Overall survival | — |
Countries
United Kingdom
Outcome results
None listed