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
1 other identifier
interventional
36
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2002
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFebruary 8, 2017
February 1, 2017
3.8 years
September 12, 2005
February 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To determine the feasibility and toxicity of the combination of etanercept and rituximab in patients with CLL/SLL.
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.
up to 1 year
Study Arms (1)
Arm I
EXPERIMENTALEtanercept 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).
Interventions
(375 mg/m2) Using Stepped-Up Dosing Thrice Weekly, weeks 2-5
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- No pregnant or breastfeeding women
- ECOG PS =4
- Life expectancy of \>12 weeks
- Patients with bilirubin or creatinine\>3.0 mg/dl
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- John Byrdlead
Study Sites (1)
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Related 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. doi: 10.1038/leu.2008.385. Epub 2009 Feb 19.
PMID: 19225537RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Byrd, MD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
October 1, 2002
Primary Completion
August 1, 2006
Study Completion
August 1, 2009
Last Updated
February 8, 2017
Record last verified: 2017-02