Bortezomib in Treating Patients With Lymphoproliferative Disorders
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|ClinicalTrials.gov Identifier: NCT00023764|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : April 1, 2014
Last Update Posted : December 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma||Drug: bortezomib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders|
|Study Start Date :||June 2001|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
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.
- Response Rate [ Time Frame: Up to 3 years ]The response probability will be estimated. The 95% confidence interval will be provided.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|