18 and older, any sex, with Non-Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (Complete Response and Partial Response) After Three Inductions Cycles of Treatment.Primary· At baseline and at the completion of 3 cycles of treatment where 1 cycle equals 35 days.
The primary objective of this study is to assess the overall response rate. Overall response rate at this time point will be defined as complete response \[CR\] plus partial response \[PR\]) after 3 cycles of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL.
Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase \[LDH\]) definit
Group
Value
95% CI
Bortezomib and Rituximab
71
Overall Response Rate After 1 Course of Induction TherapySecondary· At baseline and at the completion of cycle 1 (1 cycle =35 days)
Overall response rate (ORR) after 1 cycle of bortezomib/rituximab induction therapy.
Overall response rate at this time point will be defined as complete response \[CR\] plus partial response \[PR\]) after 1 cycle of bortezomib/rituximab induction therapy for patients with previously untreated low-grade, B-cell NHL.
Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g., lactate dehydrogenase \[LDH\]
Group
Value
95% CI
Bortezomib and Rituximab
33
Overall Response Rate After Completion of Maintenance TherapySecondary· At baseline and every 2 months during treatment of up to 3 cycles of induction (1 cycle =35days) and 4 cycles of maintenance (1 cycle =2 months) for up to 12 months.
Overall response rate at completion of bortezomib/rituximab maintenance therapy.
Overall response rate at this time point will be defined as complete response \[CR\] plus partial response \[PR\]) after 3 cycles of bortezomib/rituximab induction therapy and up to 4 cycles of maintenance for patients with previously untreated low-grade, B-cell NHL.
Complete response requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g.
Group
Value
95% CI
Bortezomib and Rituximab
71
Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination TreatmentSecondary· Day 1 of each cycle and at the completion of cycles 1 and 3, during treatment up to 12 months
Assess the safety and tolerance of bortezomib/rituximab as induction and maintenance therapy. Data will be collected for grade 3 and grade 4 adverse events experienced by patients that are determined to be at least possibly related to at least one study drug. Toxicity data for bortezomib/rituximab will be collected on day 1 of every cycle (1 cycle = 35 days) for up to 7 cycles during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:
Grade 1 Mild
Neutropenia
Group
Value
95% CI
Bortezomib and Rituximab
2
Fever
Group
Value
95% CI
Bortezomib and Rituximab
2
Infection
Group
Value
95% CI
Bortezomib and Rituximab
2
Infusion reaction (rituximab)
Group
Value
95% CI
Bortezomib and Rituximab
2
Cardiac
Group
Value
95% CI
Bortezomib and Rituximab
2
Fatigue
Group
Value
95% CI
Bortezomib and Rituximab
2
Throbocytopenia
Group
Value
95% CI
Bortezomib and Rituximab
1
Diarrhea
Group
Value
95% CI
Bortezomib and Rituximab
1
Correlation of Tumor BurdenSecondary· At the start of treatment and at Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, PFS and OS for all patients is reported at 4 years.
Correlation of tumor burden according to Groupe D'Etude des Lymphomes Follicularies (GELF) with recently developed Follicular Lymphoma International Prognostic Index (FLIPI) prognostic index. All patients enrolled in the study were required to have high tumor burden (HTB) as defined by GELF, where HTB is defined as representing higher risk disease and poorer outcomes than low tumor burden (LTB). Patients were put into low risk or high risk FLIPI groups. Low risk group with a score of 0-2 and high risk group with a score of 3-5.
A FLIPI score of 0 to 1 = "low risk" with a 10 year overall survi
4 year PFS high risk FLIPI
Group
Value
95% CI
Bortezomib and Rituximab
26
4 year PFS low risk FLIPI
Group
Value
95% CI
Bortezomib and Rituximab
60
4 year OS high risk FLIPI
Group
Value
95% CI
Bortezomib and Rituximab
81
4 year OS low risk FLIPI
Group
Value
95% CI
Bortezomib and Rituximab
92
Percentage of Patients With Treatment FailureSecondary· Median follow up for all patients was 50 months and on intent to treat, TTF rate for all patients is reported at 4 years.
Time to Treatment Failure (TTF) rate measured, from the time of first treatment to disease progression, relapse, second tumor, death from any cause, treatment toxicity requiring termination from the study, or for any reason treatment is discontinued permanently.
Group
Value
95% CI
Bortezomib and Rituximab
26
Progression Free Survival (PFS) RateSecondary· Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, PFS for all patients is reported at 4 years.
Progression Free Survival is measured from the time of first induction infusion to disease progression, relapse, second tumor, or death from any cause.
Progressive disease (PD) requires the following:
1. Appearance of any new lesion or increase by \> 50% in the size of previously involved sites.
2. Increase of \> 50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver nodules and spleen nodules or unequivocal progression in any non measurable disease or nondominant site.
3. \> 50% increase in greatest diameter of any previously identified node greater than 1 cm i
Group
Value
95% CI
Bortezomib and Rituximab
44
Overall Survival RateSecondary· Median follow up for all patients was 50 months (range 12-78 months) and on intent to treat, OS rate for all patients is reported at 4 years.
Overall survival (OS) will be measured from the time of first treatment to death from any cause.
Group
Value
95% CI
Bortezomib and Rituximab
87
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected for the whole study over a 6 year and 4 month period. On average adverse event information for each patient was collected during patients treatment, for a maximum of 12 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northwestern University
Last refreshed: 6 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00369707.