Mantle cell lymphoma
Conditions
Interventions
Product Name: Mabthera
Product Code: Ro45 2994
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/
Sponsors
GELA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with histologically confirmed mantle cell lymphoma - Advanced stages II-IV - Previously untreated - 65 years and older or 60-65 if not eligible for high dose chemotherapy 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: -WHO performance status of 3 or more -Known anti-murine antibody (HAMA) reactivity or Known hypersensitivity to murine antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of lymphoma mass measured by CR rate progression-free survival after end of initial chemotherapy;Secondary Objective: To compare mainntenance therapy of Rituximab with maitenance with interferon-alfa or pegylated interferon for progression free survival, after 2 different regimens of induction chemo-immunotherapy in elderly patients with mantle cell lymphoma;Primary end point(s): First randomisation: percentages of complete responses after initial chemotherapy Second randomisation: Progression free survival in CR or PR after initial cytoreductive chemotherapy End of observation: overall survival after start/end of initial cytoreductive chemotherapy | — |
Countries
Belgium
Outcome results
None listed