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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00250861
• Other study ID #: US-I-IL2-04-029
• Status: Terminated
• Phase: Phase 2
• First received: November 7, 2005
• Last updated: April 17, 2008
• Start date: October 2005
• Est. completion date: August 2007

Study information

• Verified date: April 2008
• Source: US Oncology Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

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).

EXCLUSION CRITERIA:

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Rituximab

• Aldesleukin

Locations

Country	Name	City	State
United States	Texas Cancer Center	Arlington	Texas
United States	Hematology Oncology Associates of IL	Chicago	Illinois
United States	Texas Cancer Center at Medical City	Dallas	Texas
United States	Rocky Mountain Cancer Center-Midtown	Denver	Colorado
United States	Puget Sound Cancer Center-Edmonds	Edmonds	Washington
United States	El Paso Cancer Treatment Ctr	El Paso	Texas
United States	Fairfax Northern VA Hem-Onc PC	Fairfax	Virginia
United States	San Antonio Tumor & Blood Clinic	Fredericksburg	Texas
United States	Texas Oncology, PA	Garland	Texas
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Kansas City Cancer Centers-Central	Kansas	Missouri
United States	Greater Dayton Cancer Center	Kettering	Ohio
United States	Longview Cancer Center	Longview	Texas
United States	Minnesota Oncology Hematology, PA	Minneapolis	Minnesota
United States	Cancer Care & Hematology Specialists of Chicagoland	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Onc and Hem Associates of SW VA, Inc.	Salem	Virginia
United States	Pudget Sound Cancer Center-Seattle	Seattle	Washington
United States	Cancer Care Northwest-North	Spokane	Washington
United States	Tyler Cancer Center	Tyler	Texas
United States	Yakima Valley Mem Hosp/North Star Lodge	Yakima	Washington

Sponsors (3)

Lead Sponsor	Collaborator
US Oncology Research	Chiron Corporation, Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States,