Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders
I. Determine the frequency and duration of complete and partial response rates in patients
with grade I, II, or III follicular lymphoma or mantle cell lymphoma treated with
I. Determine the response of minimal residual disease by polymerase chain reaction (PCR)
detectable or clonotypic PCR minimal residual disease in bone marrow of patients treated
with this regimen.
II. Determine the time to progression and overall survival of patients treated with this
III. Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients are stratified according to disease type (follicular lymphoma vs mantle
Patients receive an infusion of bortezomib over 3-5 seconds once weekly for 4 weeks.
Treatment repeats every 6 weeks in the absence of disease progression or unacceptable
toxicity. Patients who achieve at least a partial response lasting at least 6 months may
Patients are followed every 3 months for 1 year and then every 4 months for 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The response probability will be estimated. The 95% confidence interval will be provided.
Up to 3 years
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
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