Nonmyeloablative Allogeneic Stem Cell Transplantation For Relapsed Hodgkin's or Non-Hodgkin's Lymphoma After Autologous Transplantation ( A BMT Study)
- Determine the 1-year progression-free and overall survival rate in patients with
relapsed Hodgkin's or non-Hodgkin's lymphoma after prior autologous stem cell
transplantation treated with a nonmyeloablative conditioning regimen comprising
fludarabine and melphalan followed by allogeneic bone marrow or peripheral blood stem
cell transplantation and immunosuppression comprising tacrolimus and methotrexate.
- Determine treatment-related mortality in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine engraftment of donor hematopoietic stem cells, as measured by hematopoietic
recovery and donor-derived hematopoiesis (determined by T cell and neutrophil specific
chimerism) at 2, 3, 6, and 12 months, in patients treated with this regimen.
- Determine the incidence of acute and chronic graft-versus-host disease in patients
treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis
(Hodgkin's lymphoma vs non-Hodgkin's lymphoma).
Patients receive fludarabine IV over 1 hour on days -6 to -2 and melphalan IV over 15-20
minutes on days -3 and -2. Patients undergo allogeneic peripheral blood stem cell or bone
marrow transplantation on day 0. Patients receive oral tacrolimus twice daily beginning on
day -3 and continuing until day 100 followed by a taper to day 180. Patients also receive
methotrexate IV on days 1, 3, and 7. Treatment continues in the absence of disease
progression or unacceptable toxicity.
After completion of study transplantation, patients are followed at 1 and 3 months, 1 year,
and then annually for up to 4 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PFS rate at 1 year.
1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration
Patrick J. Stiff, MD
United States: Federal Government
|Cardinal Bernardin Cancer Center at Loyola University Medical Center||Maywood, Illinois 60153-5500|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|Veterans Affairs Medical Center - Dayton||Dayton, Ohio 45428|
|CCOP - Dayton||Kettering, Ohio 45429|
|Via Christi Cancer Center at Via Christi Regional Medical Center||Wichita, Kansas 67214|
|Interlakes Oncology/Hematology PC||Rochester, New York 14623|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|Southwest Medical Center||Liberal, Kansas 67901|
|St. Francis Hospital and Health Centers - Beech Grove Campus||Beech Grove, Indiana 46107|
|Reid Hospital & Health Care Services, Incorporated||Richmond, Indiana 47374|
|Cancer Center of Kansas, PA - Dodge City||Dodge City, Kansas 67801|
|Highland Hospital of Rochester||Rochester, New York 14620|
|Grandview Hospital||Dayton, Ohio 45405|
|David L. Rike Cancer Center at Miami Valley Hospital||Dayton, Ohio 45409|
|Good Samaritan Hospital||Dayton, Ohio 45406|
|Blanchard Valley Medical Associates||Findlay, Ohio 45840|
|Charles F. Kettering Memorial Hospital||Kettering, Ohio 45429|
|Middletown Regional Hospital||Middletown, Ohio 45044|
|UVMC Cancer Care Center at Upper Valley Medical Center||Troy, Ohio 45373-1300|
|Ruth G. McMillan Cancer Center at Greene Memorial Hospital||Xenia, Ohio 45385|
|Cancer Center of Kansas, PA - Chanute||Chanute, Kansas 66720|
|Cancer Center of Kansas, PA - El Dorado||El Dorado, Kansas 67042|
|Cancer Center of Kansas, PA - Kingman||Kingman, Kansas 67068|
|Cancer Center of Kansas, PA - Newton||Newton, Kansas 67114|
|Cancer Center of Kansas, PA - Parsons||Parsons, Kansas 67357|
|Cancer Center of Kansas, PA - Pratt||Pratt, Kansas 67124|
|Cancer Center of Kansas, PA - Salina||Salina, Kansas 67401|
|Cancer Center of Kansas, PA - Wellington||Wellington, Kansas 67152|
|Cancer Center of Kansas, PA - Wichita||Wichita, Kansas 67214|
|Associates in Womens Health, PA - North Review||Wichita, Kansas 67208|
|Cancer Center of Kansas, PA - Medical Arts Tower||Wichita, Kansas 67208|
|Cancer Center of Kansas, PA - Winfield||Winfield, Kansas 67156|
|United States Air Force Medical Center - Wright-Patterson||Wright-Patterson AFB, Ohio 45433-5529|