Primed Peripheral Blood Stem Cell Autologous Transplantation for Lymphoma and Hodgkin's Disease
- Assess the clinical outcomes, survival, and morbidity of transplantation in patients
with Hodgkin's lymphoma or non-Hodgkin's lymphoma when treated with filgrastim (G-CSF)
followed by high dose chemotherapy plus G-CSF followed by autologous peripheral blood
stem cell (PBSC) transplantation.
- Determine whether sufficient PBSC can be collected for use in autologous
transplantation in these patients when mobilized with hematopoietic growth factor alone
compared to chemotherapy plus growth factor.
- Determine whether these primed PBSC support prompt lymphoid and myeloid hematopoietic
recovery after transplantation in these patients.
- Compare the numbers of committed progenitor cells and/or primitive, pluripotential
hematopoietic stem cells with these two priming techniques.
- Compare the numbers of tumor cells in cryopreserved PBSC following these priming
- Evaluate response and extended relapse free survival in conjunction with rapid
hematopoietic reconstitution and limited transplant associated morbidity and mortality
in these patients when treated with these regimens.
OUTLINE: In the first priming phase, patients receive filgrastim (G-CSF) subcutaneously (SQ)
daily on days 1-7 and peripheral blood stem cells are collected on days 6-8.
At least 48 hours after the last dose of G-CSF and after the third leukapheresis, patients
receive the second priming, which consists of cyclophosphamide IV over 2 hours on day 1 and
cytarabine IV over 1 hour every 12 hours for a total of 2 doses on day 1. Patients also
receive mitoxantrone IV over 1 hour daily and dexamethasone IV every 12 hours for a total of
4 doses on days 1-2. Patients receive G-CSF SQ daily beginning on day 4 and continuing until
the completion of leukapheresis. PBSC are collected on 3 consecutive days after blood counts
In the transplant phase, patients with non-Hodgkin's lymphoma who have not exceeded
pretransplant radiotherapy limits receive cyclophosphamide IV over 2 hours on days -7 and -6
and total body irradiation twice daily on days -4 through -1. Autologous PBSC are reinfused
on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until day 21 or
until blood counts recover.
Patients with Hodgkin's lymphoma or patients with non-Hodgkin's lymphoma who have exceeded
pretransplant radiotherapy limits receive cyclophosphamide IV over 2 hours daily on days -6
through -3, carmustine IV over 1 hour on day -6, and etoposide IV over 4 hours every 12
hours for a total of 6 doses on days -6 through -4. Autologous PBSC are reinfused on day 0.
Patients also receive G-CSF IV daily beginning on day 0 and continuing until day 21 or until
blood counts recover.
All patients receive radiotherapy for any residual nodal masses measuring at least 2 cm 5
days a week beginning on day 28.
Patients are followed at day 100, then every 3 months for 1 year, then every 6 months for 2
years, and then annually thereafter.
This was changed to a treatment guideline study.
Masking: Open Label, Primary Purpose: Treatment
Disease-free survival at 2 years
Daniel J. Weisdorf, MD
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|