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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201682
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 8, 2017
Information provided by (Responsible Party):
John Byrd, Ohio State University Comprehensive Cancer Center

Brief 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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Drug: Etanercept Drug: Rituximab Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Study Start Date : October 2002
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: Arm I
Etanercept 25 mg administered sub-cutaneously twice weekly (Monday and Thursday) weeks 1-5 of therapy (total of 10 doses). The third dose of etanercept will be administered 1 hour prior to receiving rituximab. Rituximab: Patients will receive 375 mg/M2 of rituximab three times weekly for four weeks (a total of 12 doses of rituximab).
Drug: Etanercept
25 mg SQ twice weekly weeks 1-5
Other Name: Enbrel

Drug: Rituximab
(375 mg/m2) Using Stepped-Up Dosing Thrice Weekly, weeks 2-5
Other Name: RITUXAN®

Primary Outcome Measures :
  1. To determine the feasibility and toxicity of the combination of etanercept and rituximab in patients with CLL/SLL. [ Time Frame: up to 1 year ]
  2. Determine if etanercept increases the complete response rate while decreasing the frequency of infusion-related toxicity in patients with CLL/SLL receiving rituximab therapy. [ Time Frame: up to 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201682

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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
John Byrd
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Principal Investigator: John Byrd, MD Ohio State University
Additional Information:
Publications of Results:
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Responsible Party: John Byrd, Principal Investigator, Ohio State University Comprehensive Cancer Center Identifier: NCT00201682    
Other Study ID Numbers: OSU-0113
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Keywords provided by John Byrd, Ohio State University Comprehensive Cancer Center:
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Gastrointestinal Agents
Immunosuppressive Agents