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A Pilot Study of Fractionated Dose Subcutaneous Rituximab (RTX, Rituxan(Registered Trademark)) in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia

Phase 1
21 Years
Not Enrolling
Chronic Lymphocytic Leukaemia Refractory

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Trial Information

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.

Inclusion Criteria


- Patients diagnosed with Chronic Lymphocytic Leukemia

- Prior therapy with fludarabine or a fludarabine containing regimen

- CD20 expression on CLL cells

- Neutrophil count ANC greater than 500/mm(3)

- Platelet count greater than 30K/mm(3)

- Age 21-99


- Bulky lymphadenopathy, defined as greater than 1 lymph node with greater than 5cm in
largest diameter

- Evidence for transformation into high grade lymphoma (Richter's transformation)

- ECOG performance 3 or higher

- Other concurrent anticancer therapies

- Less than 3 months from last systemic therapy for CLL

- Less than 6 months from last monoclonal antibody therapy

- More than 10 doses rituximab, within 12 months preceeding protocol enrollment, either
as single agent or in a combination chemotherapy regimen

- Chronic or current clinically significant infection, including HIV positivity or
hepatitis C

- Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary,
infectious, or metabolic disease of such severity that it would preclude the
patient's ability to tolerate protocol therapy

- History of mucocutaneous reactions (paraneoplastic pemphigus, Stevens-Johnson
syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal

- Known anaphylaxis or IgE mediated hypersensitivity to murine proteins or to any
component of this product

- Inability to self inject the study medication or to have it administered by a third

- Inability to understand the investigational nature of the study ability to provide
informed consent

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety profile and early evidence of efficacy of Rituxan given subcutaneously.

Outcome Time Frame:

12 weeks

Safety Issue:



United States: Federal Government

Study ID:




Start Date:

August 2006

Completion Date:

June 2009

Related Keywords:

  • Chronic Lymphocytic Leukaemia Refractory
  • CLL
  • Monoclonal Antibody Therapy
  • Anti CD20
  • Biologic Response Modifier Therapy
  • Fractionated-Dose
  • Low-Dose
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892