Lymphoma Clinical Trial
Official title:
Non-Myeloablative Chemotherapy Followed by Unrelated Allogeneic Stem Cell Transplantation in Patients With Advanced Hematologic Malignancies: A Pilot Study
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Peripheral stem cell transplantation may be able to replace
immune cells that were destroyed by chemotherapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus peripheral stem cell
transplantation in treating patients who have advanced hematologic cancer.
OBJECTIVES: I. Determine the feasibility of allogeneic engraftment after unrelated matched
allogeneic peripheral blood stem cell transplantation preceded by a nonmyeloablative,
fludarabine based conditioning regimen in patients with advanced hematologic malignancies.
II. Determine the toxicities of this regimen, especially graft versus host disease, in these
patients.
OUTLINE: Patients receive fludarabine IV over 30-60 minutes on days -7 to -4,
cyclophosphamide IV over 30 minutes on days -7 to -5, and cytarabine IV over 2 hours on days
-4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Filgrastim (G-CSF) is
administered IV over 1 hour or subcutaneously beginning on day 1 and continuing until blood
counts recover. Patients are followed weekly until day 60 and then monthly for 10 months.
PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study.
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