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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):
John Byrd, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201682
First received: September 12, 2005
Last updated: February 6, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Drug: Etanercept Drug: Rituximab Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by John Byrd, Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • To determine the feasibility and toxicity of the combination of etanercept and rituximab in patients with CLL/SLL. [ Time Frame: up to 1 year ]
  • 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 ]

Enrollment: 36
Study Start Date: October 2002
Study Completion Date: August 2009
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201682

Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
John Byrd
Investigators
Principal Investigator: John Byrd, MD Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: John Byrd, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201682     History of Changes
Other Study ID Numbers: OSU-0113
Study First Received: September 12, 2005
Last Updated: February 6, 2017

Keywords provided by John Byrd, Ohio State University Comprehensive Cancer Center:
Leukemia
Lymphoma

Additional relevant MeSH terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Etanercept
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Gastrointestinal Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 18, 2017