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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Stephanie Williams, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research

Authority:

United States: Food and Drug Administration

Study ID:

US-I-IL2-04-029

NCT ID:

NCT00250861

Start Date:

October 2005

Completion Date:

August 2007

Related Keywords:

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

Name

Location

Virginia Oncology AssociatesNewport News, Virginia  23606
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Tyler Cancer CenterTyler, Texas  75702
Rocky Mountain Cancer Center-MidtownDenver, Colorado  80218
Texas Oncology, PADallas, Texas  75246-2006
Texas Cancer Center at Medical CityDallas, Texas  75230
Greater Dayton Cancer CenterKettering, Ohio  45409
Texas Cancer CenterAbilene, Texas  79606
San Antonio Tumor & Blood ClinicFredericksburg, Texas  78624
Longview Cancer CenterLongview, Texas  75601
Onc and Hem Associates of SW VA, Inc.Salem, Virginia  24153
Cancer Care Northwest-NorthSpokane, Washington  99218
Minnesota Oncology Hematology, PAMinneapolis, Minnesota  55404
Hematology Oncology Associates of ILChicago, Illinois  60611
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
El Paso Cancer Treatment CtrEl Paso, Texas  79915
Yakima Valley Mem Hosp/North Star LodgeYakima, Washington  98902
Kansas City Cancer Centers-CentralKansas, Missouri  64111
Fairfax Northern VA Hem-Onc PCFairfax, Virginia  22031
Puget Sound Cancer Center-EdmondsEdmonds, Washington  98026
Pudget Sound Cancer Center-SeattleSeattle, Washington  98133