Overview

This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatments rituximab, bortezomib
Phase phase 2
Targets CD20, proteasome
Sponsor Northwestern University
Collaborator Robert H. Lurie Cancer Center
Start date August 2006
End date August 2016
Trial size 43 participants
Trial identifier NCT00369707, NU 06H1, STU00005335

Summary

Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. 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 rituximab may kill more cancer cells.

This phase II trial is studying how well giving bortezomib together with rituximab works as first-line therapy in treating patients with low-grade B-cell non-Hodgkin's lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
rituximab Rituxan
On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.
bortezomib Velcade, PS-341
On days 1, 8, 15 and 22 of the 1st cycle, bortezomib will be administered intravenously (through a vein) over 3-5 seconds followed by an intravenous infusion of rituximab. How long it will take to infuse the dose of rituximab is dependent upon your weight and how well you tolerate the infusion; it is estimated this first infusion may take between 3-4 hours. During subsequent cycles, bortezomib will again be given on days 1, 8, 15 and 22. However, rituximab will only be given on day 1 of each cycle.

Primary Outcomes

Measure
Overall response rate (complete response and partial response)
time frame: baseline, every 2 months at the completion of cycles 1, 2 and 3 and 2 months after cycle 3 completion and then every 6 mo for 2 yrs

Secondary Outcomes

Measure
Overall response rate after 1 course of induction therapy
time frame: every 2 months at the completion of cycles 1, 2 and 3 and 2 months after cycle 3 completion
Overall response rate after completion of maintenance therapy
time frame: every 2 months at the completion of cycles 1, 2 and 3 and 2 months after cycle 3 completion
Duration of response
time frame: every 2 months for 8 months then every 6 mos for 2 yrs
Safety and tolerability
time frame: Day 1 of each cycle and at the completion of cycles 1 and 3
Tissue evaluation
time frame: baseline and at response assessment 1, 2 and 3
Correlation of tumor burden
time frame: End of study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed low-grade B-lymphocyte non-Hodgkins lymphoma - Life expectancy > 12 months Exclusion Criteria: - No known history of HIV infection - No other active infection - No peripheral neuropathy ≥ grade 2 within the past 14 days - No uncontrolled hypertension - None of the following cardiac conditions: - Myocardial infarction within the past 6 months - No heart failure - Uncontrolled angina - Severe uncontrolled ventricular arrhythmias - Electrocardiographic evidence of acute ischemia - Active conduction system abnormalities - No serious medical or psychiatric illness that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior therapy for non-Hodgkins lymphoma - No prior bortezomib or rituximab - At least 3 weeks since prior chemotherapy, radiation therapy, immunotherapy, systemic anticancer biologic therapy, or anticancer hormonal therapy - At least 2 weeks since prior investigational drugs - No other concurrent systemic cytotoxic chemotherapy or investigational agents + No leukemia

Additional Information

Official title A Phase II Trial of Combination Bortezomib and Rituximab as Front-line Therapy for Low-grade Non-Hodgkin's Lymphoma
Principal investigator Andrew M. Evens, DO, MS
Description This is a multicenter, prospective study. - Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 of all subsequent courses. Treatment repeats every 35 days for 3 courses. Patients achieving a complete response, partial response, or stable disease proceed to maintenance therapy. - Maintenance therapy: Beginning 6-8 weeks after induction therapy, patients receive bortezomib IV over 3-5 seconds and rituximab IV on day 1. Treatment repeats every 60 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Blood and tissue samples are collected at baseline and periodically during study treatment. After completion of study therapy, patients are followed every 3 months for 2 years.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Northwestern University.