18 and older, any sex, with 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.
Maximum Tolerated Dose (MTD) and Tolerability of Bortezomib Combined With Y-90-Ibritumomab Tiuxetan Determined by Number of Dose Limiting Toxicities in a Cohort.Primary· During induction therapy, the first 28 days of treatment.
To determine the MTD using a 3+3 dose escalating design. There will be 3 dose cohorts:1.0mg/m2,1.3mg/m2 and1.6 mg/m2. 3 patients will be enrolled at dose of 1.0mg/m2 bortezomib. If no dose limiting toxicities (DLTs) are seen in the first 3 patients then dose will be escalated to next level and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, experience a DLT then MTD will be determined to be at this dose level. If 2 or more DLTs are seen in first 3 patients at that dose, then MTD will b
Group
Value
95% CI
Cohort 1: 1.0mg/m2 Bortezomib
0
Cohort 2: 1.3mg/m2 Bortezomib
0
Cohort 3: 1.6mg/m2 Bortezomib
2
Number of Patients With Adverse Events Related to Treatment of Bortezomib Combined With Y-90-ibritumomab TiuxetanSecondary· At start of treatment on days 1, 8, 15, 22 of induction, days 36 and 50 of recovery, days 1, 8, 15 of consolidation cycles for up to 3 cycles and 4 weeks after the completion of treatment.
To further explore the toxicity bortezomib combined with Y-90-ibritumomab tiuxetan by collecting data on adverse events (AE) reported by patient or collected lab results that are grade 3 or grade 4 that were determined to be at least possible related to any of the studies drugs.
Toxicity will be collected on treatment days 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 AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or d
Leukopenia
Group
Value
95% CI
Cohort 1+ Cohort 2+ Cohort 3
3
Lymphopenia
Group
Value
95% CI
Cohort 1+ Cohort 2+ Cohort 3
3
Neutropenia
Group
Value
95% CI
Cohort 1+ Cohort 2+ Cohort 3
5
Thrombocytopenia
Group
Value
95% CI
Cohort 1+ Cohort 2+ Cohort 3
4
Cardiac
Group
Value
95% CI
Cohort 1+ Cohort 2+ Cohort 3
1
Overall Response RateSecondary· At baseline, after induction cycle (1 cycle =28 days) and consolidation therapy of a maximum of 3 cycles (1cycle =28 days), up to approximately 6 months
The overall response rate at the completion of treatment was defined as complete response plus partial response.
Complete response (CR)=A post-treatment residual mass of any size is permitted as long as it is PET-negative and normalization of those biochemical abnormalities.
Partial response (PR)=50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in the size of the other nodes, liver or spleen, and no new sites of disease.
Stable disease=Failing to attain the criteria for PR or CR, but not fulfilling those for progressive disease.
Progressive disease(PD)=At
Group
Value
95% CI
Cohort 1+ Cohort 2+ Cohort 3
89
Median Progression Free SurvivalSecondary· At start of treatment, at completion of induction therapy, at completion of consolidation therapy, every 3 months for 1 year, and every 6 months for 1 year
Median progression free survival (PFS) will be assessed by CT scans after induction therapy, consolidation therapy, every 3 months for the first year following treatment and every 6 months for the second year.
Progressive disease is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size or at least a 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
Group
Value
95% CI
Cohort 1+ Cohort 2+ Cohort 3
6.5
3 – 22.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AE) for the study were collected over a 5 year period. AEs for each patient were collected during treatment through 30 days post last treatment. Treatment consisted of one 28 day induction cycle followed by 71 day recovery period and then a maximum of 3 consolidation cycles each of 28 days..
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. 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. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
This phase I/II trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with relapsed or refractory follicular 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: 4 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/NCT00372905.