Chronic Lymphocytic LeukemiaPhase 1/2NCT00201682
Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
A Phase 1/2 study testing Etanercept and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by John Byrd at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Etanercept and Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Aug 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No pregnant or breastfeeding women
- ECOG PS =4
- Life expectancy of >12 weeks
- Patients with bilirubin or creatinine>3.0 mg/dl
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: 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
Read the 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.
- Being tested
- Etanercept, Rituximab
- Keywords
- Leukemia, Lymphoma
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
25 mg SQ twice weekly weeks 1-5
RituximabDrug
Also called RITUXAN®
(375 mg/m2) Using Stepped-Up Dosing Thrice Weekly, weeks 2-5
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | 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). Receives: Drug: Etanercept; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility and toxicity of the combination of etanercept and rituximab in patients with CLL/SLL.
Measured: 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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionAug 2006
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Byrd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Byrd, Ohio State University Comprehensive Cancer Center
- Investigators
- John Byrd, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201682
- Sponsor's protocol ID
- OSU-0113
- Status last verified
- Feb 2017
- First submitted
- 12 Sep 2005
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19225537
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT00201682
- Acronym / sponsor ID
- OSU-0113
- Keywords
- Leukemia, Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- John ByrdUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Etanercept, Drug: RituximabEtanercept 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must have been previously treated CLL/SLL
- Must have CD20 expression
- ECOG PS =<3
- No prior Campath-1H
- No active infection requiring antibiotics
Key exclusion criteria (4 listed)
- No pregnant or breastfeeding women
- ECOG PS =4
- Life expectancy of >12 weeks
- Patients with bilirubin or creatinine>3.0 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptAlso: Enbrel25 mg SQ twice weekly weeks 1-5 | Drug | Arm I |
| RituximabAlso: RITUXAN®(375 mg/m2) Using Stepped-Up Dosing Thrice Weekly, weeks 2-5 | Drug | Arm I |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Results publication: PubMed 19225537Woyach 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.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Byrd, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Etanercept and Rituximab in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by John Byrd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the feasibility and toxicity of the combination of etanercept and rituximab in patients with CLL/SLL. (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00201682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.