A Pilot Study of Fractionated Dose Subcutaneous Rituximab (RTX, Rituxan(Registered Trademark)) in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia
Rituximab is FDA approved for the treatment of relapsed or refractory low grade or
follicular CD20+ B cell non Hodgkin's lymphoma (375 mg/m(2) IV infusion once weekly for 4 or
8 doses). Recently, rituximab (anti CD20) has been introduced to CLL treatment regimens and
has become an attractive choice in combination chemotherapy or as single agent treatment.
Rituximab has been shown to be effective at lower doses than 375 mg/m(2) when given more
Several theoretical considerations and supporting laboratory evidence suggest that a
fractionated dosing schedule using low-dose rituximab could be more effective than the
current i.v. schedule of high-dose rituximab. Indeed, preliminary clinical evidence suggests
that low-dose rituximab at 20mg/m2 i.v. 3-times per week can lead to steady clearance of
leukemic cells without inducing substantial loss of targeted CD20.
This is a Phase I/II , single agent study which will evaluate the safety and feasibility of
subcutaneous rituximab (Rituxan) administered at 20 mg/day three times a week for 12 weeks
in subjects with CLL. Patients need to have had prior treatment with fludarabine, and have
an elevated absolute lymphocyte count. The primary objective will be to test the safety and
feasibility of giving rituximab subcutaneously. We will also obtain as a secondary endpoint
an early estimate of efficacy as evidenced by (a) shrinkage of lymphadenopathy and/or (b)
improvement in blood values and bone marrow biopsy findings.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety profile and early evidence of efficacy of Rituxan given subcutaneously.
United States: Federal Government
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