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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201682
First received: September 12, 2005
Last updated: April 13, 2012
Last verified: April 2012

September 12, 2005
April 13, 2012
October 2002
August 2006   (final data collection date for primary outcome measure)
To determine the feasibility and toxicity of the combination of etanercept and rituximab in patients with CLL/SLL. [ Time Frame: 2002-present ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00201682 on ClinicalTrials.gov Archive Site
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Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Phase I/II Study of Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

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

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • 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®
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2009
August 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00201682
OSU-0113
Yes
Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: John Byrd Ohio State University
Ohio State University Comprehensive Cancer Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP