Phase 2
N=25
Velcade (Bortezomib, PS-341) and Rituximab in Relapsed/Refractory Mantle Cell and Follicular Non-Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma · Mantle Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00201877 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Overall Response Rate — 40; 55; 29 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Velcade (Drug); Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
40; 55; 29 | — |
| PRIMARY Assess the Toxicity of Combination Rituximab and Velcade™ in Patients With Previously Treated Mantle Cell and Follicular Lymphoma. |
13 | — |
| SECONDARY Progression-free Survival(PFS) |
24; 60 | — |
| SECONDARY Correlative Studies |
— | — |
Summary
This study will determine the overall response rate and toxicity of rituximab and Velcade in combination in patients with relapsed or refractory mantle cell non-Hodgkin's lymphoma.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed mantle cell or follicular lymphoma
- Relapsed or refractory disease
- ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, 2 or 3
Exclusion Criteria
- Pre-existing sensory or motor peripheral neuropathy
- No active or untreated CNS (Central Nervous System) lymphoma
- History of severe, life-threatening hypersensitivity or infusion reactions prior rituximab treatment.
Data sourced from ClinicalTrials.gov (NCT00201877). 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.