A Phase I Trial Combining IDEC-Y2B8 And High-Dose Beam Chemotherapy With Hematopoietic Progenitor Cell Transplant In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma
- Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan, in terms of
absorbed radiation to critical organs, when administered with high-dose chemotherapy
followed by autologous peripheral blood stem cell transplantation in patients with
relapsed or refractory B-cell non-Hodgkin's lymphoma.
- Determine whether the residual radioactivity detected at the time of stem cell
reinfusion affects the reinfused cells and delays engraftment in patients treated with
- Determine the duration of response and survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).
- Radioimmunotherapy: Patients receive rituximab IV followed by indium In 111 ibritumomab
tiuxetan (for imaging) IV over 10 minutes on day -22. Patients then receive rituximab
IV and IDEC-Y2B8 IV over 10 minutes on day -14.
Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3
of 6 patients experience dose-limiting toxicity.
- High-dose conditioning regimen: Patients receive BEAM chemotherapy comprising
carmustine IV over 2 hours on day -6, etoposide IV over 2 hours twice daily and
cytarabine IV over 1 hour twice daily on days -5 to -2, and melphalan IV over 1 hour on
- Autologous stem cell transplantation: Autologous peripheral blood stem cells are
reinfused on day 0. Patients receive filgrastim (G-CSF) subcutaneously daily beginning
on day 0 and continuing until blood counts recover.
Patients are followed at 30 days, 3 and 6 months, and then annually for 5 years.
PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose of absorbed radiation to critical organs delivered with this combination of study treatments
Dose limiting toxicities observed during and up to 30 days after the last study treatment resulting in the determination of the maximum tolerated dose of absorbed radiation to critical organs delivered by Y2B8 in combination with high-dose BEAM chemotherapy with autologous mobilized peripheral blood progenitor cell transplant
From first study treatment until 30 days after last study treatment.
Jane N. Winter, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Hematology-Oncology Associates of Illinois||Chicago, Illinois 60611-2998|