A Phase II Multicenter Randomized Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL
- Compare the 1-year overall survival rate of patients with relapsed low-grade
non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with fludarabine and
total body irradiation vs cyclophosphamide and fludarabine followed by allogeneic
peripheral blood stem cell transplantation and donor lymphocyte infusions.
- Compare the toxic effects of these regimens in these patients.
- Compare the incidence and severity of acute and chronic graft-versus-host disease in
patients treated with these regimens.
- Compare the 1-year treatment-related mortality and infectious complications in patients
treated with these regimens.
- Compare the efficacy of these treatment regimens, in terms of 1-year disease-free
survival, of these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease, age (less than 55 vs over 55), and participating transplantation center. Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fludarabine IV on days -4 to -2. Patients undergo total body
irradiation followed by allogeneic peripheral blood stem cell transplantation (PBSCT)
on day 0. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral
cyclosporine twice daily on days -2 to 90 followed by a taper on days 90-150 and oral
mycophenolate mofetil twice daily on days 0-28.
- Arm II: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on
days -3 to -2. Patients undergo PBSCT on day 0. Patients receive GVHD prophylaxis
comprising methotrexate IV on days 1, 3, 6, and 11 and tacrolimus IV continuously and
then orally on days -2 to 90 followed by a taper on days 90-150.
At approximately day 180, patients with persistent disease, evidence of T-cell chimerism,
and no GVHD may receive up to 3 donor lymphocyte infusions administered every 1-2 months.
Quality of life is assessed at baseline, 1 month, every 3 months for 1 year, and then every
6 months for 1 year.
Patients are followed at 1 month, every 3 months for 1 year, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
Allocation: Randomized, Primary Purpose: Treatment
Robert H. Collins, MD
Simmons Cancer Center
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|University of Pennsylvania Cancer Center||Philadelphia, Pennsylvania 19104|
|Simmons Cancer Center - Dallas||Dallas, Texas 75235-9154|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Massey Cancer Center||Richmond, Virginia 23298-0037|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Holden Comprehensive Cancer Center||Iowa City, Iowa 52242-1009|
|Hackensack University Medical Center||Hackensack, New Jersey 07601|
|St. Joseph's Hospital and Medical Center||Paterson, New Jersey 07503|
|Florida Hospital Cancer Institute||Orlando, Florida 32804|
|James P. Wilmot Cancer Center||Rochester, New York 14642|
|Oregon Cancer Institute||Portland, Oregon 97201-3098|
|Rocky Mountain Cancer Centers||Thornton, Colorado 80260|
|Blood and Marrow Transplant Group of Georgia||Atlanta, Georgia 30342-1601|
|University of Missouri Kansas City School of Medicine||Kansas City, Missouri 64111|
|Delaware Clinical & Laboratory Physicians||Newark, Delaware 19713|
|Texas Transplant Institute||San Antonio, Texas 78229|