Phase III Rituxan/BEAM vs. Bexxar/BEAM With Autologous Hematopoietic Stem Cell Transplantation (ASCT) for Persistent or Relapsed Chemotherapy Sensitive Diffuse Large B-cell Non-Hodgkin's Lymphoma (BMT CTN #0401)
BACKGROUND:
Bexxar (Tositumomab and Iodine I 131 Tositumomab) is a radioimmunoconjugate with
demonstrated anti-lymphoma effects. This drug is indicated for the treatment of patients
with CD20 positive, relapsed or refractory, low grade, follicular, or transformed
non-Hodgkin's lymphoma, including patients with Rituximab-refractory non-Hodgkin's lymphoma.
Bexxar has been used in several Phase I and II transplant trials either alone or in
combination with high-dose chemotherapy for the treatment of relapsed non-Hodgkin's
lymphoma. The Phase I and II trials combining Bexxar with BEAM and autologous hematopoietic
stem cell transplantation demonstrated promising early results with 80% event-free survival
in relapsed chemosensitive diffuse large B-cell non-Hodgkin's lymphoma patients. The
administration of Rituxan to the mobilization and conditioning regimen is now the standard
of care at most transplant centers. Therefore, the primary endpoint of this study will be
to compare progression-free survival after autologous hematopoietic stem cell
transplantation for chemotherapy-sensitive diffuse large B-cell lymphoma using Rituxan/BEAM
versus Bexxar/BEAM for pre-transplant conditioning.
DESIGN NARRATIVE:
All patients will receive induction or salvage chemotherapy as indicated by their clinical
circumstance to achieve at least a partial response (as defined in the protocol). There must
be 20% or less bone marrow involvement after their most recent salvage therapy.
Mobilization therapy may be employed per institutional guidelines, but all patients must
receive one dose of rituxan (375 mg/m^2) at least within 4 weeks of actual stem cell
apheresis. Patients must have an adequate autograft (target of at least 2.0 X 10^6 CD34+
cells/kg; minimum of more than 1.5 X 106 CD34+ cells/kg) to be eligible for the protocol.
Eligible patients will be randomized to receive either: 1) Rituxan plus BEAM, with Rituxan
375 mg/m^2 IV Days -19 and -12, BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 Days -5 to -2,
Cytarabine 100 mg/m^2 Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by ASCT; or,
2) Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose
calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then
receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 Days -5 to -2, Cytarabine 100 mg/m^2
Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by ASCT.
Patients will be followed for 2 years post-transplant. Survival data, hematopoiesis data,
incidence of infection, mucositis assessment data, immune reconstitution data, and toxicity
data will be recorded and reported periodically to the BMT CTN Data Coordinating Center
(DCC).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) after autologous hematopoietic stem cell transplantation (ASCT) for chemotherapy-sensitive diffuse large B-cell lymphoma using Rituxan/BEAM versus Bexxar/BEAM for pre-transplant conditioning
2 and 3 years
No
Edward Ball, MD
Principal Investigator
University of California, San Diego
United States: Food and Drug Administration
384
NCT00329030
December 2005
August 2014
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
University of California Davis Medical Center | Sacramento, California 95817 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
University of Rochester Medical Center | Rochester, New York 14642 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Baylor University Medical Center | Dallas, Texas 75246 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Michigan Medical Center | Ann Arbor, Michigan 48104-0914 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Emory University | Atlanta, Georgia 30322 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Texas Transplant Institute | San Antonio, Texas 78229 |
University of California, San Diego Medical Center | San Diego, California |
University of Miami | Miami, Florida 33136 |
University of Nebraska | Omaha, Nebraska 68198 |
Yale University School Of Medicine | New Haven, Connecticut 06520 |
University of Florida College of Medicine (Shands) | Gainesville, Florida 32610 |
Johns Hopkins/SKCCC | Baltimore, Maryland 21231 |
Washington University/Barnes Jewish Hospital | St. Louis, Missouri 63110 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
University Hospitals of Cleveland/Case Western | Cleveland, Ohio 44106 |
University of Oklahoma Medical Center | Oklahoma City, Oklahoma 73104 |
Columbia River Oncology Program | Portland, Oregon 97225 |
Tufts-New England Medical Center | Boston, Massachusetts 02111 |
St. Lukes Mountain States Tumor Institute | Boise, Idaho 83712 |
University of Maryland Medical Systems/Greenbaum Cancer Center | Baltimore, Maryland 21228 |
Cancer Institute of New Jersey, Robert Wood Johnson University | New Brunswick, New Jersey 08903 |
Weill Cornell Medical College, The New York Presbyterian Hospital | New York, New York 10065 |
University of North Carolina Hospital at Chapel Hill | Chapel Hill, North Carolina 27599 |
Intermountain BMT Program | Salt Lake City, Utah 84143 |
University of Utah Medical School, BMT | Salt Lake City, Utah 84132 |
Virginia Commonwealth University/MCV Hospital | Richmond, Virginia 23298 |