Bortezomib in Treating Patients With Lymphoproliferative Disorders
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders|
- Response Rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]The response probability will be estimated. The 95% confidence interval will be provided.
|Study Start Date:||June 2001|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive an infusion of bortezomib (dose of 1.8 mg/m2) 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 receive retreatment.
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 bortezomib.
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 regimen.
III. Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients are stratified according to disease type (follicular lymphoma vs mantle cell lymphoma).
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 receive retreatment.
Patients are followed every 3 months for 1 year and then every 4 months for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023764
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||John Gerecitano||Memorial Sloan Kettering Cancer Center|