Autologous Stem Cell Transplantation for Poor Prognosis, Relapsed, or Refractory Intermediate-High Grade B-Cell Lymphoma Using Gemcitabine Plus High Dose BCNU and Melphalan Followed by Anti-CD20 Moab (IDEC C2B8, Rituximab, Rituxan) and Consolidative Chemotherapy
OBJECTIVES: I. Evaluate the 1 and 2 year event free survival of patients with poor
prognosis, relapsed or refractory intermediate or high grade B-cell non-Hodgkin's lymphoma
who receive high dose carmustine and melphalan plus gemcitabine followed by rituximab
(IDEC-C2B8 monoclonal antibody; anti-CD20 monoclonal antibody) plus sargramostim and
consolidation chemotherapy with alternating dexamethasone/cyclophosphamide/
etoposide/cisplatin plus gemcitabine and paclitaxel/cisplatin and compare these figures to a
historical control population. II. Evaluate the ability of posttransplant rituximab therapy
in combination with sargramostim (GM-CSF) to control and further treat residual lymphoma
remaining after high dose therapy in these patients. III. Evaluate quality of life
parameters and assess the risk of secondary malignancies following this treatment regimen in
OUTLINE: Patients receive high dose gemcitabine IV over 100 minutes on day -5 and again
approximately 6 hours after carmustine IV over 2 hours on day -2. On day -1, patients
receive melphalan IV over 20 minutes followed 24 hours later (day 0) with peripheral blood
stem cells transplantation. Patients then receive sargramostim (GM-CSF) subcutaneously
beginning on day 4 until granulocyte count is greater than 1,000/mm3 for 2 consecutive days.
At weeks 5-8 posttransplant, patients receive rituximab (IDEC-C2B8 monoclonal antibody;
anti-CD20 monoclonal antibody) IV over 3-4 hours weekly. Prior to rituximab treatment at
week 4 posttransplant, patients receive sargramostim (GM-CSF) subcutaneously 3 times a week
continuing through rituximab therapy. At approximately 3 and 9 months posttransplant,
patients receive dexamethasone orally every day for days 1-4, and cyclophosphamide,
etoposide, and cisplatin by continuous infusion for 4 days (days 1-4), and gemcitabine IV
over 100 minutes on days 1 and 5. At approximately 6 and 12 months posttransplant, patients
receive paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3.
Patients are followed at least every 6 weeks to 3 months until death.
PROJECTED ACCRUAL: An estimated 25 patients per year will be accrued into this study.
Primary Purpose: Treatment
Aaron P. Rapoport, MD
University of Maryland Greenebaum Cancer Center
United States: Federal Government
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201|