Trial of Outpatient Immunotherapy With Rituximab and Aldesleukin (IL-2) vs. Rituximab Alone for Non-Hodgkin's Lymphoma
NCT ID: NCT00250861
Last Updated: 2008-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
110 participants
INTERVENTIONAL
2005-10-31
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Rituximab
Aldesleukin
Eligibility Criteria
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Inclusion 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.
* 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).
Exclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Chiron Corporation
INDUSTRY
Fred Hutchinson Cancer Center
OTHER
US Oncology Research
INDUSTRY
Principal Investigators
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Stephanie Williams, MD
Role: PRINCIPAL_INVESTIGATOR
US Oncology Research
Locations
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Rocky Mountain Cancer Center-Midtown
Denver, Colorado, United States
Hematology Oncology Associates of IL
Chicago, Illinois, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States
Kansas City Cancer Centers-Central
Kansas City, Missouri, United States
Greater Dayton Cancer Center
Kettering, Ohio, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Texas Cancer Center
Arlington, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
El Paso Cancer Treatment Ctr
El Paso, Texas, United States
San Antonio Tumor & Blood Clinic
Fredericksburg, Texas, United States
Texas Oncology, PA
Garland, Texas, United States
Longview Cancer Center
Longview, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Fairfax Northern VA Hem-Onc PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Onc and Hem Associates of SW VA, Inc.
Salem, Virginia, United States
Puget Sound Cancer Center-Edmonds
Edmonds, Washington, United States
Pudget Sound Cancer Center-Seattle
Seattle, Washington, United States
Cancer Care Northwest-North
Spokane, Washington, United States
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, United States
Countries
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Other Identifiers
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US-I-IL2-04-029
Identifier Type: -
Identifier Source: org_study_id