Bortezomib and Fludarabine With or Without Rituximab in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
A Phase I Trial of PS-341 and Fludarabine for Relapsed and Refractory Indolent Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
5 other identifiers
interventional
18
1 country
7
Brief Summary
This phase I trial is studying the side effects and best dose of bortezomib when given together with fludarabine with or without rituximab in treating patients with relapsed or refractory indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with fludarabine with or without rituximab may kill more cancer cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 10, 2003
CompletedFirst Posted
Study publicly available on registry
September 11, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedSeptember 30, 2013
September 1, 2013
5.4 years
September 10, 2003
September 27, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria version 2.0
3 weeks
Study Arms (1)
Treatment (bortezomib, fludarabine, rituximab)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Diagnosis of chronic lymphocytic leukemia (CLL) OR indolent non-Hodgkin's lymphoma (NHL) of any of the following subtypes:
- Follicular lymphoma:
- Grade I follicular small cleaved cell;
- Grade II follicular mixed cell;
- Grade II follicular large cell;
- Diffuse small cleaved cell;
- Small lymphocytic lymphoma;
- Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia)
- AND
- Extranodal marginal zone B-cell lymphoma (mucosa-associated lymphoid tissue \[MALT\] lymphoma);
- Nodal marginal zone B-cell lymphoma (monocytoid B-cell lymphoma);
- Splenic marginal zone lymphoma (splenic lymphoma with villous lymphocytes);
- Mantle cell lymphoma:
- No blastic phase mantle cell lymphoma
- Relapsed or refractory, progressive disease:
- +42 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Mercy Medical Center
Canton, Ohio, 44708, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106, United States
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, 44130, United States
UHHS-Chagrin Highlands Medical Center
Orange, Ohio, 44122, United States
University Suburban Medical Center
South Euclid, Ohio, 44121, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda Cooper
Case Western Reserve University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2003
First Posted
September 11, 2003
Study Start
July 1, 2003
Primary Completion
December 1, 2008
Last Updated
September 30, 2013
Record last verified: 2013-09