Phase 2 N=42 Treatment

Trial of VELCADE and Rituxan as Front-line Tx for Low-grade NHL

Non-Hodgkin's Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00369707 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Oct 2018

Primary outcome: Primary: Overall Response Rate (Complete Response and Partial Response) After Three Inductions Cycles of Treatment. — 71 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rituximab (Drug); bortezomib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Response Rate (Complete Response and Partial Response) After Three Inductions Cycles of Treatment.	71	—
SECONDARY Overall Response Rate After 1 Course of Induction Therapy	33	—
SECONDARY Overall Response Rate After Completion of Maintenance Therapy	71	—
SECONDARY Duration of Overall Response	—	—
SECONDARY Number of Patients That Experience Adverse Events With Bortezomib/Rituximab Combination Treatment	2; 2; 2; 2; 2; 2	—
SECONDARY Tissue Evaluation	—	—
SECONDARY Correlation of Tumor Burden	26; 60; 81; 92	—
SECONDARY Percentage of Patients With Treatment Failure	26	—
SECONDARY Progression Free Survival (PFS) Rate	44	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00369707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.