Bortezomib and Fludarabine With or Without Rituximab in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00068315|
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : September 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hematopoietic/Lymphoid Cancer Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Splenic Marginal Zone Lymphoma Waldenström Macroglobulinemia||Drug: bortezomib Drug: fludarabine phosphate Biological: rituximab||Phase 1|
I. Determine the safety and toxicity of bortezomib and fludarabine with or without rituximab in patients with relapsed or refractory indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
II. Determine the maximum tolerated dose of bortezomib in combination with fludarabine in these patients.
III. Determine the biological effect of this regimen on apoptotic markers, cell cycle kinase inhibitors, and DNA repair in these patients.
OUTLINE: This is a multicenter, dose-escalation study of bortezomib.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and fludarabine IV over 30 minutes on days 1-3 or 1-5. Patients may also receive rituximab IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of PS-341 and Fludarabine for Relapsed and Refractory Indolent Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||December 2008|
Experimental: Treatment (bortezomib, fludarabine, rituximab)
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and fludarabine IV over 30 minutes on days 1-3 or 1-5. Patients may also receive rituximab IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Other Names:Drug: fludarabine phosphate
Other Names:Biological: rituximab
- Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria version 2.0 [ Time Frame: 3 weeks ]
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): NCT00068315
|United States, Ohio|
|Mercy Medical Center|
|Canton, Ohio, United States, 44708|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Southwest General Health Center Ireland Cancer Center|
|Middleburg Heights, Ohio, United States, 44130|
|UHHS-Chagrin Highlands Medical Center|
|Orange Village, Ohio, United States, 44122|
|University Suburban Medical Center|
|South Euclid, Ohio, United States, 44121|
|UHHS-Westlake Medical Center|
|Westlake, Ohio, United States, 44145|
|Principal Investigator:||Brenda Cooper||Case Western Reserve University|