Extended treatment with rituximab in patients with B-cell post-transplant lymphoproliferative diease
A multicentre phase II trial of extended treatment with rituximab to assess complete remission rate in patients with B-cell post-transplant lymphoproliferative diease
Alberto Fernández de Sevilla on behalf of the Catalan Institute of Oncology
40 participants
Nov 1, 2000
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- Signed informed consent, untreated B-cell lymphoproliferative disease, CD20 expression.
Exclusion Criteria1
- Central nervous system disease, serious concomitant diseases.
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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 complete remission after 8 courses were followed up every 3 monts during 2 years or until progression
Locations(1)
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ACTRN12607000190404