Clinical trial · Interventional
Velcade (Bortezomib, PS-341) and Rituximab in Relapsed/Refractory Mantle Cell and Follicular Non-Hodgkin's Lymphoma
A Phase II Study of Velcade (Bortezomib, PS-341) and Rituximab in Relapsed/Refractory Mantle Cell and Follicular Non-Hodgkin's Lymphoma
NCT00201877CI-TRIAL-00032018completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
| Velcade | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Velcade and Rituximab
- description
- Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration. Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14
- interventionNames
- Drug: Velcade
- Drug: Rituximab
Primary outcomes (2)
- measure
- Overall Response Rate
- timeFrame
- Every 3 months
- description
- To determine the overall survival in patients with relapsed or refractory mantle cell and follicular lymphoma following treatment with rituximab and Velcade™.
- measure
- Assess the Toxicity of Combination Rituximab and Velcade™ in Patients With Previously Treated Mantle Cell and Follicular Lymphoma.
- timeFrame
- Day 1 of each cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTBaiocchi RA, Alinari L, Lustberg ME, Lin TS, Porcu P, Li X, Johnston JS, Byrd JC, Blum KA. Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma. Cancer. 2011 Jun 1;117(11):2442-51. doi: 10.1002/cncr.25792. Epub 2010 Dec 14. PMID 24048792