Lymphoma, Non-HodgkinPhase 2/3NCT00045877
Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments
A Phase 2/3 study testing Recombinant Human Interleukin-2 and Rituximab in people with Lymphoma, Non-Hodgkin, run by Chiron Corporation at 65 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 low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments. 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
- 65 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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
None listed.
Who cannot join
- Subjects who showed no tumor response or a response lasting <6 months to treatment with Rituximab in combination with Chemotherapy or another therapeutic modality (radiation or radioimmunoconjugates).
- HIV positive.
- Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism.
- Clinically significant cardiac, pulmonary, and /or hepatic dysfunction (if subject has history of congestive heart failure or myocardial infarction, must have been stable for at least 6 months, and have no current symptoms
- If cardiac ejection fraction has been measured, it must be greater than 50%.
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Cancer Care Center
Bloomington, Indiana, 47403
Erie County Medical Center
Buffalo, New York, 14215
Fletcher Allen Health Care
Burlington, Vermont, 05401
Gabrail Cancer Center
Canton, Ohio, 44718
Northwestern University Medical School
Chicago, Illinois, 60611
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus, Ohio, 43210
Hematology Oncology Consultants, Inc.
Columbus, Ohio, 43235
California Oncology of the Central Valley
Fresno, California, 93710
Virginia K. Crosson Cancer Center
Fullerton, California, 92835
Germantown Cancer Foundation
Germantown, Tennessee, 38138
Pacific Shores Medical Group
Glendale, California, 91204
Wilshire Oncology Medical Group
Glendora, California, 91741
Benefis Healthcare
Great Falls, Montana, 59405
California Cancer Care Inc.
Greenbrae, California, 94904
East Carolina University School of Medicine, Department of Medicine, Division of Hematology/Oncology
Greenville, North Carolina, 27858-4354
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Northern New Jersey Cancer Associates
Hackensack, New Jersey, 07601
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
Pacific Shores Medical Group
Huntington Beach, California, 92648
Indiana Oncology and Hematology Consultants
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64111
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Santa Barbara Hematology Oncology Medical Group
Lompoc, California, 93438
Pacific Shores Medical Group
Long Beach, California, 90813
Pacific Shores Medical Group
Los Alamitos, California, 90720
UCLS Medical Center
Los Angeles, California, 90095
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207
Division of Hematology/Oncology, University of Miami, School of Medicine
Miami, Florida, 33136
Facey Medical Foundation
Mission Hills, California, 91345
North Valley Hematology-Oncology Medical Group
Mission Hills, California, 91345
Hematology and Oncology Specialists, LLC
New Orleans, Louisiana, 70115
Advanced Oncology Associates
New Rochelle, New York, 10801
Weill Medical College of Cornell University/New York Presbyterian Hospital
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029
Hoag Cancer Center
Newport Beach, California, 92658
North Valley Hematology/Oncology Medical Group
Northridge, California, 91328
Whittingham Cancer Center
Norwalk, Connecticut, 06856
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
Oncology Specialists,S.C.
Park Ridge, Illinois, 60068
UCLA Medical Group/Pasadena Oncology
Pasadena, California, 91105
Wilshire Oncology Medical Group
Pasadena, California, 91105
Wilshire Oncology Medical Group
Pomona, California, 91767
Oregon Health & Science University
Portland, Oregon, 97201
Southwest Cancer Care
Poway, California, 92064
Wilshire Oncology Medical Group
Rancho Cucamonga, California, 91730
Cancer Care Associates Meidcal Group, Inc.
Redondo Beach, California, 90277
Virginia Cancer Institute
Richmond, Virginia, 23230
UC Davis Cancer Center
Sacramento, California, 95817
Sansum Santa Barbara Foundation Medical Clinic
Santa Barbara, California, 93105
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105
Santa Barbara Hematology Oncology Medical Group
Santa Maria, California, 93454
John Wayne Cancer Institute
Santa Monica, California, 90404
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, 04074
Louisiana State University Health Sciences Center and VA
Shreveport, Louisiana, 71130
Santa Barbara Hematology Oncology Medical Group
Solvang, California, 93463
Cancer Care Associates Medical Group, Inc.
Torrance, California, 90505
UCLA/Santa Clarita Valley Cancer Center
Valencia, California, 91355
Ventura County Hematology-Oncology Specialists
Ventura, California, 93003
San Diego Cancer Center Medical Group
Vista, California, 92083
Wilshire Oncology Medical Group
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 low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Recombinant Human Interleukin-2 and Rituximab
- Keywords
- Low-Grade or Follicular Non-Hodgkin's Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Follicular
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 2/3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Chiron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045877
- Sponsor's protocol ID
- IL2NHL03
- 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 Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments
- ClinicalTrials.gov ID
- NCT00045877
- Acronym / sponsor ID
- IL2NHL03
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Low-Grade or Follicular Non-Hodgkin's Lymphoma
- Phase
- Phase 2/3
- 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 low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments.
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 (0 listed)
Key exclusion criteria (5 listed)
- Subjects who showed no tumor response or a response lasting <6 months to treatment with Rituximab in combination with Chemotherapy or another therapeutic modality (radiation or radioimmunoconjugates).
- HIV positive.
- Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism.
- Clinically significant cardiac, pulmonary, and /or hepatic dysfunction (if subject has history of congestive heart failure or myocardial infarction, must have been stable for at least 6 months, and have no current symptoms
- If cardiac ejection fraction has been measured, it must be greater than 50%.
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.
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Recombinant Human Interleukin-2 and Rituximab in people with Lymphoma, Non-Hodgkin, run by Chiron Corporation at 65 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 0 inclusion and 5 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 65 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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; AzTrials last refreshed its copy on 6 Nov 2026.