Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201682
• Other study ID #: OSU-0113
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: February 6, 2017
• Start date: October 2002
• Est. completion date: August 2009

Study information

• Verified date: February 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase I/II study of the combination of etanercept and rituximab in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This combination is proposed to improve the efficacy and diminish the toxicity of this the

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2009
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Etanercept
25 mg SQ twice weekly weeks 1-5
• Rituximab
(375 mg/m2) Using Stepped-Up Dosing Thrice Weekly, weeks 2-5

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
John Byrd

Country where clinical trial is conducted

United States, 

References & Publications (1)

Woyach JA, Lin TS, Lucas MS, Heerema N, Moran ME, Cheney C, Lucas DM, Wei L, Caligiuri MA, Byrd JC. A phase I/II study of rituximab and etanercept in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma. Leukemia. 2009 May;23(5):912-8 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the feasibility and toxicity of the combination of etanercept and rituximab in patients with CLL/SLL.		up to 1 year
Primary	Determine if etanercept increases the complete response rate while decreasing the frequency of infusion-related toxicity in patients with CLL/SLL receiving rituximab therapy.		up to 1 year

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