A Phase II Study to Evaluate the Safety and Efficacy of IV Busulfan, Melphalan, and Thiotepa (BuMelTT) Followed By Autologous PBSC Infusion for Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma
- Determine the therapeutic efficacy of a myeloablative preparative regimen comprising
busulfan, melphalan, and thiotepa followed by autologous peripheral blood stem cell
(PBSC) transplantation in patients with Hodgkin's or non-Hodgkin's lymphoma.
- Determine the toxic effects of this preparative regimen in these patients.
- Myeloablative preparative regimen: Patients receive busulfan IV over 3 hours on days -8
to -6, melphalan IV over 15-30 minutes on days -5 and -4, and thiotepa IV over 2 hours
on days -3 and -2.
- Peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC
transplantation on day 0 followed by filgrastim (G-CSF) IV over 30 minutes beginning on
day 5 and continuing until blood counts recover.
- Intrathecal chemotherapy: Patients with a history of treated CNS disease or at
high-risk for CNS relapse receive methotrexate and cytarabine intrathecally (IT) for 2
doses each within 10 days prior to transplantation and 4-6 doses each beginning on day
- Consolidation therapy: Patients with residual bulk disease at 80-100 days
post-transplantation that is > 2.5 cm by CT scan may undergo local radiotherapy to
residual scar/disease provided it can be encompassed in a single radiation port and the
volume of lung to be irradiated is ≤ 20%.
After completion of study treatment, patients are followed weekly for 1 month, monthly for 6
months, every 3 months for 6 months, every 6 months for 1 year, and then annually
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival at 3, 6, 9, 12, 18, and 24 months post transplantation
3, 6, 9, 12, 18, and 24 months post transplantation
Richard Maziarz, MD
OHSU Knight Cancer Institute
United States: Institutional Review Board
|Knight Cancer Institute at Oregon Health and Science University||Portland, Oregon 97239-3098|