This clinical trial studies fludarabine phosphate and total-body radiation followed by donor peripheral blood stem cell transplant and immunosuppression in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with fludarabine phosphate, cyclosporine, and mycophenolate mofetil before transplant may stop this from happening.
PRIMARY OBJECTIVES: I. To estimate the rate of grade III/IV graft-versus-host disease (GVHD) in patients treated with low-dose total body irradiation (TBI), fludarabine (fludarabine phosphate), PBSC infusion and immunosuppression with mycophenolate mofetil and a disease risk-based cyclosporine taper. II. To estimate the risk of graft rejection, GVHD, disease response, non-relapse mortality and the incidence and severity of infectious complications using this treatment strategy. OUTLINE: Patients are assigned to 1 of 2 treatment groups. ARM I (indolent disease): CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: Patients undergo donor peripheral blood stem cell transplantation (PBSCT) on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) or IV every 8-12 hours on days -3 to 56 with a taper to day 180 and mycophenolate mofetil PO BID or IV every 8-12 hours on days 0 to 27. ARM II (aggressive disease): CONDITIONING REGIMEN: Patients receive fludarabine phosphate and undergo TBI as in Arm I. TRANSPLANTATION: Patients undergo donor PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID or IV every 8-12 hours on days -3 to 56 with a taper to day 70 and mycophenolate mofetil as in Arm I. After completion of study treatment, patients are followed up for 5 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Given IV
Undergo TBI
Undergo PBSCT
Undergo PBSCT
Given PO or IV
Given IV or PO
Correlative studies
University of Arizona Health Sciences Center
Tucson, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
Stanford University Hospitals and Clinics
Stanford, California, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Baylor University Medical Center
Dallas, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
Universitaet Leipzig
Leipzig, Germany
...and 1 more locations
Probability of severe (grade III/IV) GVHD in each arm
95% confidence interval will be calculated.
Time frame: Up to day 84
Probability of severe (grade III/IV) GVHD in each arm
95% confidence intervals will be calculated.
Time frame: Up to 5 years
Incidence of graft rejection
Chimerism analysis by fluorescent in situ hybridization (FISH) or variable number tandem repeat (VNTR). Examined and reported in a descriptive manner. Confidence intervals will be presented.
Time frame: Day 28
Incidence of graft rejection
Chimerism analysis by FISH or VNTR. Examined and reported in a descriptive manner. Confidence intervals will be presented.
Time frame: Day 56
Incidence of graft rejection
Chimerism analysis by FISH or VNTR. Examined and reported in a descriptive manner. Confidence intervals will be presented.
Time frame: Day 84
Incidence of graft rejection
Chimerism analysis by FISH or VNTR. Examined and reported in a descriptive manner. Confidence intervals will be presented.
Time frame: Day 180
Incidence of graft rejection
Chimerism analysis by FISH or VNTR. Examined and reported in a descriptive manner. Confidence intervals will be presented.
Time frame: Day 365
Incidence of non-relapse mortality
Examined and reported in a descriptive manner. Confidence intervals will be presented.
Time frame: Up to 5 years
Incidence of infectious complications
Examined and reported in a descriptive manner. Confidence intervals will be presented.
Time frame: Up to 5 years
Severity of infectious complications
Examined and reported in a descriptive manner. Confidence intervals will be presented.
Time frame: Up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.