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Phase I/II Study of Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Phase 1/Phase 2
18 Years
Not Enrolling
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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Trial Information

Phase I/II Study of Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Rationale: Previous research has demonstrated that rituximab has efficacy against chronic
lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Rituximab is a monoclonal
antibody used to treat different types of lymphomas. Monoclonal antibodies are a type of
immunotherapy used against some types of cancer. They are produced in a laboratory and
designed to target as well as bind with cells that carry specific proteins. Rituximab
attaches to a protein called CD20 that is found almost exclusively on the surface of
B-cells. Once rituximab attaches to the protein, the immune system activates to kill the
malignant B-cells. Researchers are investigating what other therapies to combine with
rituximab to reduce side effects and improve patient outcomes. The current study combines
etanercept with rituximab. Etanercept is an anti-inflammatory agent being tested as a
therapy for cancer. Researchers want to assess the theory that etanercept may reduce the
toxicity associated with rituximab in patients and increase efficacy while providing its own
treatment benefit to patients.

Purpose: This study is evaluating the safety and efficacy of combination etanercept and
rituximab in patients with CLL and SLL. The biological response of tumor cells and the
immune system to this drug combination will also be measured in patients before, during, and
after therapy administration.

Treatment: Patients in this study will receive etanercept and rituximab. Etanercept is given
through injections into the skin and rituximab through intravenous infusions. During the
first week of the study, etanercept alone will be given to patients two times. During the
second week, patients will continue receiving etanercept twice weekly and begin receiving
rituximab three times weekly. This schedule of etanercept twice weekly and rituximab three
times weekly will be repeated four times. Several tests and exams will be given throughout
the study to closely monitor patients. Treatments will be discontinued due to disease growth
or unacceptable side effects.

Inclusion Criteria:

- Must have been previously treated CLL/SLL

- Must have CD20 expression

- ECOG PS =<3

- No prior Campath-1H

- No active infection requiring antibiotics

- No concurrent immunosuppressive therapy

- No prior history demyelinating neurologic disease

- No active viral hepatitis

Exclusion Criteria:

- No pregnant or breastfeeding women

- ECOG PS =4

- Life expectancy of >12 weeks

- Patients with bilirubin or creatinine>3.0 mg/dl

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:

To determine the feasibility and toxicity of the combination of etanercept and rituximab in patients with CLL/SLL.

Outcome Time Frame:


Safety Issue:


Principal Investigator

John Byrd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2002

Completion Date:

August 2009

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Leukemia
  • Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma



Ohio State UniversityColumbus, Ohio  43210