Autologous Versus Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Patients With Chemosensitive Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response or First Partial Response (BMT CTN #0202)
BACKGROUND:
Although patients with follicular non-Hodgkin's lymphoma (NHL) typically experience a
relatively indolent course, the disease is rarely curable with conventional chemotherapy.
Patients with follicular NHL are usually treated only when symptoms require palliation or if
bulky disease exists since no survival advantage has been shown as compared to administering
conventional treatment at initial diagnosis. While most patients achieve a remission with
initial chemotherapy, a continuous pattern of relapse occurs, resulting in progressively
shorter remission durations. Additionally, the increased response rates conferred by
anthracycline-containing regimens have not translated into improved survival and thus the
median survival time of 6 to 10 years has not been significantly impacted over the last
decade.
DESIGN NARRATIVE:
The overall study design is a comparison of two treatment arms determined by biologic
assignment, based on the availability of an HLA-matched sibling, in patients diagnosed with
relapsed follicular non-Hodgkin's lymphoma. Patients without an HLA-matched sibling will
receive an autologous HSCT. Patients with an HLA-matched sibling will receive a
non-myeloablative allogeneic HSCT.
The overall study design is that of biologic assignment, based on the availability of an
HLA-matched sibling, to one of two strategies to improve the outcome for follicular lymphoma
patients with chemosensitive disease. All patients will undergo cytoreduction with
cyclophosphamide 4 gm/m^2 and rituximab 375 mg/m^2 x 2 doses. Rituximab will be given in
two doses, approximately 1 week apart, with the cyclophosphamide administered the day after
the first dose of rituximab. Patients assigned to the autologous arm will have their
hematopoietic stem cells mobilized from this cytoreductive regimen. Patients with an
HLA-matched sibling will undergo a non-myeloablative allogeneic HSCT. Pre-transplant
conditioning will consist of fludarabine 30 mg/m^2/day and cyclophosphamide 750 mg/m^2/day x
3 days with rituximab 375 mg/m^2/day on Days -13 and -6 pre-HSCT and on Days +1 and +8
post-HSCT. The immunosuppressive regimen will consist of tacrolimus and methotrexate (MTX)
to control graft-versus-host and host-versus-graft reactions. Patients without an
HLA-matched sibling who have collected an adequate autologous hematopoietic cell graft,
defined as at least 2.0 * 10^6 CD34+ cells/kg, will receive a preparative regimen of total
body irradiation (TBI) 1200 cGy or Carmustine (BCNU) 15 mg/kg. In addition, VP-16 60 mg/kg
and cyclophosphamide 100 mg/kg will be given for both autologous preparative regimens.
Post-autologous HSCT therapy with rituximab 375 mg/m^2 weekly x 4 doses will commence
between Days 42-75 post-HSCT.
Initial Patient
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Lymphoma Progression-free Survival
Three years post-Hematopoietic Stem Cell Transplant (HSCT)
No
Ginna G. Laport, MD
Study Chair
Stanford Hospital and Clinics
United States: Federal Government
419
NCT00096460
August 2004
March 2009
Name | Location |
---|---|
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Scripps Clinic | La Jolla, California 92037 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Baylor University Medical Center | Dallas, Texas 75246 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Vanderbilt University | Nashville, Tennessee 37232-6305 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Michigan Medical Center | Ann Arbor, Michigan 48104-0914 |
Oregon Health Sciences University | Portland, Oregon |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Emory University | Atlanta, Georgia 30322 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
UCSD Medical Center | La Jolla, California 92093 |
Stanford Hospital and Clinics | Stanford, California 94305 |
University of Florida College of Medicine (Shands) | Gainesville, Florida 32610 |
Karmanos Cancer Institute/BMT | Detroit, Michigan 48201 |
Kansas City Cancer Centers | Kansas City, Missouri 64111 |
Washington University/Barnes Jewish Hospital | St. Louis, Missouri 63110 |
University Hospitals of Cleveland/Case Western | Cleveland, Ohio 44106 |
University of Texas/MD Anderson CRC | Houston, Texas 77030 |
Indiana BMT at Beech Grove | Beech Grove, Indiana 46107 |
Virginia Commonwealth University MCV Hospitals | Richmond, Virginia 23298-0037 |
BMT Group of Georgia | Atlanta, Georgia |
Loyola University | Atlanta, Georgia |