Non-Hodgkin's LymphomaPhase 2NCT00250861
Trial of Outpatient Immunotherapy With Rituximab and Aldesleukin (IL-2) vs. Rituximab Alone for Non-Hodgkin's Lymphoma
A Phase 2 study testing Rituximab and Aldesleukin in people with Non-Hodgkin's Lymphoma, run by US Oncology Research at 21 sites in United States.
Trial summary
The purpose of this research study is to find out if treatment with rituximab in combination with aldesleukin (compared to rituximab alone) decreases the risk of cancer returning, as well as determining what other effects (good and bad) this drug combination has on NHL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Rituximab and Aldesleukin
- How many people
- 110 participants
- Where
- 21 sitesUnited States
- Study dates
- Oct 2005to Aug 2007
- 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
- Adult, Older adult
Who may be able to join
- A patient will be eligible for inclusion in this study if s/he meets all of the following criteria:
- Has previously undergone BEAC or BEAM autologus SCT with PBSC rescue for any stage aggressive B-cell NHL, including transformed indolent NHL or mantle cell lymphoma according to REAL classification - only B-cell lymphomas are permitted.
- ECOG performance status 0-1.
- Previously histological documented CD20 +NHL.
- Is greater than 18 years of age.
- Is 30-100 days from autologous peripheral blood stem cell transplant.
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- Must meet laboratory values (see protocol for values): Absolute neutrophils, hemoglobin and platelets.
- Has a negative serum pregnancy test within 7 days prior to trial registration (only for female patients of childbearing potential).
- If fertile, patient (male or female) has agreed to use physician-approved method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.
- Has signed a Patient Informed Consent Form.
- Has signed a Patient Authorization Form (HIPAA).
Who cannot join
- Patients will be taken off treatment if any of the following occur:
- ECOG PS >2.
- A history of hypersensitivity to study drugs, or any component thereof, or anaphylactic history to murine protein.
- Manifested cardiac complications during transplant, including arrthymias, congestive heart failure, angina, or myocardial infarct, or had a decreased LVEF to <45% prior to transplant
- On systemic corticosteroids.
- Diffusion capacity <60% (corrected) and has decreased 30% or more following transplant
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- Documented disease progression (See Section 10.1.6 for definition).
- Active infection, and/or is known to be seropositive for hepatitis B, hepatitis C, or HIV
- Pericardial effusion, pleural effusions, or ascites.
- A history of very aggressive NHL, such as Burkitt's or atypical Burkitt's lymphoma
- Receiving concurrent immunotherapy or rituximab therapy.
- Previously received a solid organ transplant.
- History of CNS involvement.
- A serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
- A history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs.
- A pregnant or nursing woman.
- Unable to comply with requirements of study.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Texas Cancer Center
Arlington, Texas, 76014
Hematology Oncology Associates of IL
Chicago, Illinois, 60611
Texas Cancer Center at Medical City
Dallas, Texas, 75230
Rocky Mountain Cancer Center-Midtown
Denver, Colorado, 80218
Puget Sound Cancer Center-Edmonds
Edmonds, Washington, 98026
El Paso Cancer Treatment Ctr
El Paso, Texas, 79915
Fairfax Northern VA Hem-Onc PC
Fairfax, Virginia, 22031
San Antonio Tumor & Blood Clinic
Fredericksburg, Texas, 78624
Texas Oncology, PA
Garland, Texas, 75042
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615
Kansas City Cancer Centers-Central
Kansas City, Missouri, 64111
Greater Dayton Cancer Center
Kettering, Ohio, 45409
Longview Cancer Center
Longview, Texas, 75601
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, 55404
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, 60714
Virginia Oncology Associates
Norfolk, Virginia, 23502
Onc and Hem Associates of SW VA, Inc.
Salem, Virginia, 24153
Pudget Sound Cancer Center-Seattle
Seattle, Washington, 98133
Cancer Care Northwest-North
Spokane, Washington, 99218
Tyler Cancer Center
Tyler, Texas, 75702
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, 98902
About this study
Official title: A Randomized Phase II Trial of Outpatient Immunotherapy With Rituximab and Aldesleukin (IL-2) vs. Rituximab Alone for CD20 Positive Aggressive Non-Hodgkin's Lymphoma Following High Dose Therapy With Autologous PBSC Rescue
The purpose of this research study is to find out if treatment with rituximab in combination with aldesleukin (compared to rituximab alone) decreases the risk of cancer returning, as well as determining what other effects (good and bad) this drug combination has on NHL. Rituximab and aldesleukin are not approved in combination by the Food and Drug Administration (FDA) for the treatment of non-Hodgkins lymphoma; however, Rituximab is approved for use by itself to treat NHL.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Rituximab, Aldesleukin
- 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.
RituximabDrug
AldesleukinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionAug 2007
- Study completionAug 2007
Why it stopped: Study terminated due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants
Sponsor and investigators
- Lead sponsor
- US Oncology Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiron Corporation, Fred Hutchinson Cancer Center
- Investigators
- Stephanie Williams, MD, Principal investigator, US Oncology Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250861
- Sponsor's protocol ID
- US-I-IL2-04-029
- Status last verified
- Apr 2008
- First submitted
- 7 Nov 2005
- Last updated
- 21 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Outpatient Immunotherapy With Rituximab and Aldesleukin (IL-2) vs. Rituximab Alone for CD20 Positive Aggressive Non-Hodgkin's Lymphoma Following High Dose Therapy With Autologous PBSC Rescue
- ClinicalTrials.gov ID
- NCT00250861
- Acronym / sponsor ID
- US-I-IL2-04-029
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of enrollment.
- Enrolment
- 110 participants
- Lead sponsor
- US Oncology ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Chiron Corporation, Fred Hutchinson Cancer Center
- Study start
- Oct 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Nov 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.
The purpose of this research study is to find out if treatment with rituximab in combination with aldesleukin (compared to rituximab alone) decreases the risk of cancer returning, as well as determining what other effects (good and bad) this drug combination has on NHL. Rituximab and aldesleukin are not approved in combination by the Food and Drug Administration (FDA) for the treatment of non-Hodgkins lymphoma; however, Rituximab is approved for use by itself to treat NHL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A patient will be eligible for inclusion in this study if s/he meets all of the following criteria:
- Has previously undergone BEAC or BEAM autologus SCT with PBSC rescue for any stage aggressive B-cell NHL, including transformed indolent NHL or mantle cell lymphoma according to REAL classification - only B-cell lymphomas are permitted.
- ECOG performance status 0-1.
- Previously histological documented CD20 +NHL.
- Is greater than 18 years of age.
Key exclusion criteria (17 listed)
- ECOG PS >2.
- A history of hypersensitivity to study drugs, or any component thereof, or anaphylactic history to murine protein.
- Manifested cardiac complications during transplant, including arrthymias, congestive heart failure, angina, or myocardial infarct, or had a decreased LVEF to <45% prior to transplant
- On systemic corticosteroids.
- Diffusion capacity <60% (corrected) and has decreased 30% or more following transplant
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 |
|---|---|---|
| Rituximab | Drug | – |
| Aldesleukin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Study terminated due to lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2008.
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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.
Stephanie Williams, MD principal investigator
US Oncology Research
21 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 Rituximab and Aldesleukin in people with Non-Hodgkin's Lymphoma, run by US Oncology Research at 21 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 11 inclusion and 17 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: stopped early, as of the sponsor's last update on 21 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 was stopped early (reason given: Study terminated due to lack of enrollment.). Results are not available in the source record.
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 21 Apr 2008.