Study Stopped
Study terminated due to lack of enrollment.
Trial of Outpatient Immunotherapy With Rituximab and Aldesleukin (IL-2) vs. Rituximab Alone for Non-Hodgkin's Lymphoma
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
1 other identifier
interventional
110
1 country
21
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2005
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 7, 2005
CompletedFirst Posted
Study publicly available on registry
November 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedApril 21, 2008
April 1, 2008
1.8 years
November 7, 2005
April 17, 2008
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Oncology Researchlead
- Chiron Corporationcollaborator
- Fred Hutchinson Cancer Centercollaborator
Study Sites (21)
Rocky Mountain Cancer Center-Midtown
Denver, Colorado, 80218, United States
Hematology Oncology Associates of IL
Chicago, Illinois, 60611, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, 60714, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, 55404, United States
Kansas City Cancer Centers-Central
Kansas City, Missouri, 64111, United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615, United States
Texas Cancer Center
Arlington, Texas, 76014, United States
Texas Cancer Center at Medical City
Dallas, Texas, 75230, United States
El Paso Cancer Treatment Ctr
El Paso, Texas, 79915, United States
San Antonio Tumor & Blood Clinic
Fredericksburg, Texas, 78624, United States
Texas Oncology, PA
Garland, Texas, 75042, United States
Longview Cancer Center
Longview, Texas, 75601, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Fairfax Northern VA Hem-Onc PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Onc and Hem Associates of SW VA, Inc.
Salem, Virginia, 24153, United States
Puget Sound Cancer Center-Edmonds
Edmonds, Washington, 98026, United States
Pudget Sound Cancer Center-Seattle
Seattle, Washington, 98133, United States
Cancer Care Northwest-North
Spokane, Washington, 99218, United States
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, 98902, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Williams, MD
US Oncology Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 7, 2005
First Posted
November 8, 2005
Study Start
October 1, 2005
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
April 21, 2008
Record last verified: 2008-04