Low Dose Total-Body Irradiation And Fludarabine Followed By HLA Matched Allogeneic Stem Cell Transplantation For Hematologic Malgnancies - A Multi-Center Study
- Determine the response rate and duration of response in patients with low-risk
hematologic malignancies treated with low-dose total-body irradiation (TBI) and
fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a
slow immunosuppression taper and donor leukocyte infusions (DLI).
- Determine the response rate and duration of response in patients with high-risk
hematologic malignancies treated with low-dose TBI and fludarabine followed by
HLA-matched allogeneic stem cell transplantation followed by a faster immunosuppression
taper and DLI.
- Determine the incidence and extent of graft-versus-host disease, regimen-related
toxicity, and engraftment in patients treated with these regimens.
- Assess the quality of life of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups (high-risk vs
low-risk hematologic malignancy). The high-risk group includes acute myelogenous leukemia,
myelodysplastic syndromes, accelerated phase chronic myelogenous leukemia (CML), second
chronic phase CML, and non-Hodgkin's lymphoma. The low-risk group includes Hodgkin's
lymphoma, first chronic phase CML, multiple myeloma, and chronic lymphocytic leukemia.
Patients receive fludarabine IV on days -4 to -2. Patients undergo total-body irradiation on
day 0 followed by allogeneic stem cell transplantation. Patients also receive oral
mycophenolate mofetil on days 0-28.
High-risk patients receive oral cyclosporine twice daily on days -2 to day 60. Patients with
persistent disease, T-cell chimerism, and no graft-vs-host disease (GVHD) on day 90 receive
up to 3 doses of donor leukocyte infusion (DLI) over the next 4 months.
Low-risk patients receive oral cyclosporine twice daily on days -2 to day 150. Patients with
persistent disease, T-cell chimerism, and no GVHD on day 180 receive up to 3 doses of DLI
over the next 4 months.
Quality of life is assessed at baseline and at 1, 3, 6, 9, 12, 18, and 24 months.
Patients are followed at 1, 3, 6, 9, and 12 months and then annually for 2 years.
PROJECTED ACCRUAL: A total of 120 patients (60 per group) will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Robert H. Collins, MD
Simmons Cancer Center
United States: Federal Government
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center||Nashville, Tennessee 37232-2516|
|St. Joseph's Hospital and Medical Center||Paterson, New Jersey 07503|
|Florida Hospital Cancer Institute||Orlando, Florida 32804|
|Cancer Institute at Oregon Health and Science University||Portland, Oregon 97201-3098|
|Massey Cancer Center at Virginia Commonwealth University||Richmond, Virginia 23298-0037|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|Cancer Center at Hackensack University Medical Center||Hackensack, New Jersey 07601|
|Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390-9063|
|Blood and Marrow Transplant Group of Georgia||Atlanta, Georgia 30342-1601|
|Texas Transplant Institute||San Antonio, Texas 78229|
|Rocky Mountain Cancer Centers - Denver Midtown||Denver, Colorado 80218|
|Kansas City Cancer Centers - Central||Kansas City, Missouri 64111|