High-Dose Therapy and Autologous Stem Cell Transplantation During Remission in Poor-Risk Age-Adjusted International Prognostic Index High and High-Intermediate Risk Group Patients With Intermediate Grade and High-Grade Non-Hodgkin's Lymphoma Including Mantle Cell Lymphoma
- To evaluate the outcome of patients with poor-risk, age-adjusted International
Prognostic Index high- and high-intermediate-risk, intermediate- and high-grade
non-Hodgkin lymphoma undergoing high-dose therapy comprising etoposide and
cyclophosphamide, either carmustine or total-body irradiation, and autologous stem cell
transplantation (ASCT) given as a consolidation therapy.
- To evaluate the role of high-dose therapy and ASCT during first partial or complete
remission (1PR/CR) in patients with poor-risk primary mediastinal large cell lymphoma.
- To evaluate the role of high-dose therapy and ASCT during first 1PR/CR in patients with
advanced-stage mantle cell lymphoma.
- To evaluate the short-term and long-term toxicities of high-dose therapy and ASCT when
performed during 1PR/CR in patients with poor-risk aggressive lymphomas.
OUTLINE: Patients are stratified according to disease (diffuse mixed, diffuse large cell,
and immunoblastic lymphoma vs primary mediastinal large cell lymphoma vs small noncleaved
cell lymphoma vs stage IV mantle cell lymphoma).
Patients' peripheral blood stem cells (PBSC) are collected after mobilization. A minimum of
2.0 x 10^6 CD34+ cells/kg must be collected. Patients experiencing disease progression
during stem cell collection will be removed from study. Patients are assigned to undergo 1
of 2 therapeutic regimens.
- Regimen 1: Patients undergo total-body irradiation (TBI) on days -8 to -5 and receive
etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2.
Patients undergo autologous PBSC transplantation on day 0.
- Regimen 2 (for patients who have received any prior thoracic irradiation or patients
who underwent previous irradiation that precludes the use of TBI): Patients receive
carmustine IV over 2 hours on days -7 to -5. Patients then receive etoposide and
cyclophosphamide and undergo autologous PBSC transplantation as in regimen 1.
Patients with residual bulky disease greater than 5 cm may undergo involved-field
radiotherapy before or after transplantation.
Patients are followed at days 7, 14, 21, 100 and 180 after PBSC transplantation, every 6
months for 3 years, and then annually thereafter.
Masking: Open Label, Primary Purpose: Treatment
Auayporn P. Nademanee, MD
Beckman Research Institute
United States: Federal Government