None listed
Conditions
Brief summary
Not randomized trial of treatment with standard doses of rituximab for untreated B-cell lymphoproliferative disease. Treatment regimen was adapted to early response, patients received 4 to 8 courses of rituximab.
Interventions
Treatment with 4 courses, one per week during 4 weeks, of intravenous Rituximab at a dose of 375 mg/m2 (standard doses). Patients who progressed were excluded from the study. Patients in complete remission after 4 courses were followed without further treatment. Participants in complete remission after 4 courses were followed up every 3 monts during 2 years or until progression. Patients with partial response received another 4 weekly courses of rituximab at the same doses. Participants in com
Treatment with 4 courses, one per week during 4 weeks, of intravenous Rituximab at a dose of 375 mg/m2 (standard doses). Patients who progressed were excluded from the study. Patients in complete remission after 4 courses were followed without further treatment. Participants in complete remission after 4 courses were followed up every 3 monts during 2 years or until progression. Patients with partial response received another 4 weekly courses of rituximab at the same doses. Participants in complete remission after 8 courses were followed up every 3 monts during 2 years or until progression
Sponsors
Alberto Fernández de Sevilla on behalf of the Catalan Institute of Oncology
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Signed informed consent, untreated B-cell lymphoproliferative disease, CD20 expression.
Exclusion criteria
Central nervous system disease, serious concomitant diseases.
Outcome results
None listed