Dose Finding Study of IDEC-Y2B8 With Autologous Stem Cell Support
I. To determine the maximum tolerated dose of IDEC-Y2B8 when administered with rituximab in
vivo purging and autologous stem cell rescue.
II. To obtain correlative laboratory data of in vivo purging with rituximab in patients with
0-35% marrow involvement.
OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan
PART I: Patients receive rituximab IV on days 1, 8, 15, and 22 and cyclophosphamide IV over
1 hour on day 25. Filgrastim (G-CSF) is administered subcutaneously (SC) daily beginning on
day 26 and continuing until autologous peripheral blood stem cells (PBSC) are harvested.
PART II: Beginning 4-6 weeks after completion of the fourth rituximab infusion, patients
receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 followed by dosimetry
imaging on days 1, 2, 4, and 7. Patients then receive IDEC-Y2B8 IV over 10 minutes once
between days 8-15.
The initial 3 patients receive the same dose of IDEC-Y2B8 and then subsequent cohorts of 3-5
patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose is
PART III: All patients undergo PBSC transplantation (PBSCT) beginning after residual bone
marrow radioactivity resolves. G-CSF is administered SC beginning 1 day after PBSCT and
continuing until blood counts recover.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD, defined in terms of clinical toxicities graded using the CTC version 2.0
The modified continual reassessment method (CRM) will be employed to estimate the MTD.
Up to day 15
Johns Hopkins University
United States: Food and Drug Administration
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