Lymphoma, Non-HodgkinPhase 2NCT00045864
Proleukin in Combination With Rituxan in Patients With Intermediate and High-Grade Non-Hodgkin's Lymphoma.
A Phase 2 study testing Recombinant Human Interleukin-2 and Rituximab in people with Lymphoma, Non-Hodgkin, run by Chiron Corporation at 33 sites in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with intermediate-and high- grade Non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Recombinant Human Interleukin-2 and Rituximab
- How many people
- Not given
- Where
- 33 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 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
- Diagnosis: CD20+ B-cell non-Hodgkin's lymphoma (NHL) classified as intermediate- or high-grade according to the Working Formulation, subtypes D to H. Must have measureable progressive or refractory disease after no more than three prior chemotherapy regimens.
Who cannot join
- Clinically significant cardiac dysfunction, or a history of myocardial infarction or heart failure within 6 months of first study treatment
- Clinically significant pulmonary dysfunction.
- Liver disease (note hepatitis C seropositive subjects may be enrolled if they have no active disease as demonstrated by undetectable HCV viral loads, biopsy showing no active disease, and/or history of normal transaminases on at least three different dates within one year of first study treatment).
- Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism.
- History of autoimmune disease.
- History of positive serology for human immunodeficiency virus (HIV).
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Cancer Care Center
Bloomington, Indiana, 47403
Gabrail Cancer Center
Canton, Ohio, 44718
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
Rush Cancer Institute
Chicago, Illinois, 60612
Oncology Hematology Care Inc.
Cincinnati, Ohio, 45242
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Hematology /Oncology Consultants Inc.
Columbus, Ohio, 43235
Cancer Specialists of South Texas, P.A.
Corpus Christi, Texas, 78412
Roger Maris Health System
Fargo, North Dakota, 58122
Germantown Cancer Center
Germantown, Tennessee, 38138
East Carolina University School of Medicine/ Division of Hematology/Oncology
Greenville, North Carolina, 27858
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64111
Dartmouth-Hitchcock-Medical Center
Lebanon, New Hampshire, 03756
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207
Division of Hematology/Oncology, University of Miami School of Medicine
Miami, Florida, 333136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Hoag Cancer Center
Newport Beach, California, 92658
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Heath and Science University
Portland, Oregon, 97201
Virginia Cancer Institute
Richmond, Virginia, 23230
UC Davis Cancer Center
Sacramento, California, 95817
John Wayne Cancer Institute
Santa Monica, California, 90404
Louisiana Health Sciences Center, Department of Medicine, Hematology/Oncology
Shreveport, Louisiana, 71130
Arch Medical Group, LLC
St Louis, Missouri, 63141
Stanford University Medical Center
Stanford, California, 94305-5151
Our Lady of Mercy Medical Center, Comprehensive Cancer Center
The Bronx, New York, 10466
ACRC/Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85712
Georgetown University Medical Center, Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
California Cancer Medical Center
West Covina, California, 91790
About this study
The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with intermediate-and high- grade Non-Hodgkin's lymphoma.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Recombinant Human Interleukin-2 and Rituximab
- Keywords
- Intermediate and High-Grade Non-Hodgkin's Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Interleukin-2 and RituximabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Chiron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045864
- Sponsor's protocol ID
- IL2NHL05
- Status last verified
- Feb 2006
- First submitted
- 12 Sep 2002
- Last updated
- 6 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proleukin in Combination With Rituxan in Patients With Intermediate and High-Grade Non-Hodgkin's Lymphoma.
- ClinicalTrials.gov ID
- NCT00045864
- Acronym / sponsor ID
- IL2NHL05
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Intermediate and High-Grade Non-Hodgkin's Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Chiron CorporationIndustry (pharma, biotech, devices)
- First posted
- 16 Sep 2002 (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.
The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with intermediate-and high- grade Non-Hodgkin's lymphoma.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis: CD20+ B-cell non-Hodgkin's lymphoma (NHL) classified as intermediate- or high-grade according to the Working Formulation, subtypes D to H. Must have measureable progressive or refractory disease after no more than three prior chemotherapy regimens.
Key exclusion criteria (6 listed)
- Clinically significant cardiac dysfunction, or a history of myocardial infarction or heart failure within 6 months of first study treatment
- Clinically significant pulmonary dysfunction.
- Liver disease (note hepatitis C seropositive subjects may be enrolled if they have no active disease as demonstrated by undetectable HCV viral loads, biopsy showing no active disease, and/or history of normal transaminases on at least three different dates within one year of first study treatment).
- Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism.
- History of autoimmune disease.
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 |
|---|---|---|
| Recombinant Human Interleukin-2 and Rituximab | Drug | – |
Primary outcome
Not reported in the source record.
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 6 Feb 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Interleukin-2 and Rituximab in people with Lymphoma, Non-Hodgkin, run by Chiron Corporation at 33 sites 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 1 inclusion and 6 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 6 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites 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 phase mean?
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.
Where can I read the original study information?
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 6 Feb 2006.