Lymphoma Clinical Trial
Official title:
A Phase II Study of the Combination of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease
RATIONALE: Tacrolimus and mycophenolate mofetil may be an effective treatment for
graft-versus-host disease caused by donor stem cell transplantation.
PURPOSE: This phase II trial is studying how well giving tacrolimus together with
mycophenolate mofetil works in preventing acute graft-versus-host disease in patients who
are undergoing donor stem cell transplantation for advanced hematologic cancer.
OBJECTIVES:
Primary
- Determine the efficacy of tacrolimus and mycophenolate mofetil in preventing acute
graft-vs-host disease in patients with advanced hematologic malignancies undergoing
allogeneic peripheral blood stem cell transplantation.
Secondary
- Determine the safety of this regimen in these patients.
OUTLINE: This is a non-randomized study.
Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 60 followed
by a taper to day 180. Patients also receive mycophenolate mofetil IV over 2 hours or orally
twice daily on days 0-60 followed by a taper to day 180. Treatment is discontinued at day
180 in the absence of graft-vs-host disease.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Supportive Care
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