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Trial of Outpatient Immunotherapy With Rituximab and Aldesleukin (IL-2) vs. Rituximab Alone for Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00250861
Recruitment Status : Terminated (Study terminated due to lack of enrollment.)
First Posted : November 8, 2005
Last Update Posted : April 21, 2008
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Rituximab Drug: Aldesleukin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2005
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All


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.
  • 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).


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.
  • A pregnant or nursing woman.
  • Unable to comply with requirements of study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250861

United States, Colorado
Rocky Mountain Cancer Center-Midtown
Denver, Colorado, United States, 80218
United States, Illinois
Hematology Oncology Associates of IL
Chicago, Illinois, United States, 60611
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States, 60714
United States, Minnesota
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Kansas City Cancer Centers-Central
Kansas, Missouri, United States, 64111
United States, Ohio
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Texas
Texas Cancer Center
Arlington, Texas, United States, 76014
Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230
El Paso Cancer Treatment Ctr
El Paso, Texas, United States, 79915
San Antonio Tumor & Blood Clinic
Fredericksburg, Texas, United States, 78624
Texas Oncology, PA
Garland, Texas, United States, 75042
Longview Cancer Center
Longview, Texas, United States, 75601
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Fairfax Northern VA Hem-Onc PC
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Onc and Hem Associates of SW VA, Inc.
Salem, Virginia, United States, 24153
United States, Washington
Puget Sound Cancer Center-Edmonds
Edmonds, Washington, United States, 98026
Pudget Sound Cancer Center-Seattle
Seattle, Washington, United States, 98133
Cancer Care Northwest-North
Spokane, Washington, United States, 99218
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
US Oncology Research
Chiron Corporation
Fred Hutchinson Cancer Research Center
Principal Investigator: Stephanie Williams, MD US Oncology Research
More Information

ClinicalTrials.gov Identifier: NCT00250861     History of Changes
Other Study ID Numbers: US-I-IL2-04-029
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: April 21, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents