Phase II Trial of Increased Dose Rituximab Plus Maintenance Rituximab for Initial Systemic Treatment of Indolent B-Cell Lymphomas
- All participants will receive increased-dose rituximab through a vein in the arm once a
week for 4 weeks (on Days 1, 8, 15, and 22 of the initial 28-day study cycle). This
first cycle of study treatment is called the Induction Phase. If the participant
responds well to the Induction Phase, they then may continue to the Maintenance Therapy
Phase, where they will receive a lower dose of rituximab once every three months for up
to 2 years.
- During the Induction Phase, the following procedures will take place before the
participant receives each dose of rituximab: medical review, physical exam,
performance status, and ECG. Blood tests will be drawn about 30-60 minutes after the
first dose of rituximab on Day 1. Samples will be drawn immediately before each dose
and again 30-60 minutes after each dose on Days 1, 8, 15 and 22.
- During the Maintenance Therapy Phase, the following procedures will take place before
the participant receives each dose of rituximab: medical review, physical exam,
performance status, ECG, blood tests and response assessments by CT scan.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine complete response rate of increased dose rituximab in indolent B-cell lymphomas
Jeremy Abramson, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|