Trial Information

Autologous Transplantation for Non-Hodgkin's Lymphoma and Hodgkin's Disease Using Retrovirally Marked Peripheral Blood Progenitor Cells Obtained After In Vivo Mobilization Using Hematopoietic Cytokines Plus Chemotherapy

OBJECTIVES:

- Determine whether priming with hematopoietic cytokines and chemotherapy increases the
yield of hematopoietic progenitors in peripheral blood stem cells (PBSC) in patients
with non-Hodgkin's lymphoma or Hodgkin's disease undergoing autologous PBSC
transplantation.

- Determine whether in vitro studies can predict the transduction efficiency of early and
late engrafting hematopoietic stem cells in this patient population undergoing this
treatment.

- Determine whether in vitro transduction of a graft product stable long term
transduction of marrow cells in these patients after autologous transplantation.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) twice daily on days 1-7.
Peripheral blood stem cells (PBSC) are collected on days 5-7. Patients receive
cyclophosphamide IV over 2 hours, mitoxantrone IV, and cytarabine IV every 12 hours for 2
doses on day 10, and dexamethasone every 12 hours for 4 doses on days 10 and 11. Patients
receive G-CSF SC for the next 10-20 days. Additional PBSC are collected on days 25-28 or 29.
Beginning 7 days before PBSC transplantation, patients receive cyclophosphamide IV over 2
hours on days -7 and -6 and total body irradiation (TBI) twice daily on days -4 to -1.
Patients unable to tolerate TBI receive cyclophosphamide IV over 2 hours on days -6 to -3,
carmustine IV over 1 hour on days -6, and etoposide IV over 1 hour every 12 hours on days -6
to -4. Retrovirally transduced PBSC are reinfused on day 0 followed by another course of
G-CSF SC until hematopoietic recovery.

Patients are followed at 1, 3, 6, 9, 12, 18, and 24 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 12-15
months.