CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Velcade +1 moredrug
Likely dose
Bortezomib 1.3 mg/m² IV on days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14 (induction); rituximab 375 mg/m² IV on day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 (induction)AI-extracted
Key inclusion· 3
  • ✓Histologically confirmed mantle cell or follicular lymphoma
  • ✓Relapsed or refractory disease
  • ✓ECOG performance status 0, 1, 2, or 3
Key exclusion· 3
  • ✕Pre-existing sensory or motor peripheral neuropathy
  • ✕Active or untreated CNS lymphoma
  • ✕History of severe, life-threatening hypersensitivity or infusion reactions to prior rituximab treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00201877
NCT00201877Phase 2Completed
CompareCT.gov

A Phase II Study of Velcade (Bortezomib, PS-341) and Rituximab in Relapsed/Refractory Mantle Cell and Follicular Non-Hodgkin's Lymphoma

Ohio State University Comprehensive Cancer Center·interventional·Posted Sep 20, 2005·Updated Mar 12, 2018

In Brief

A Phase 2 clinical trial evaluating Velcade and Rituximab for Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma, Mantle Cell Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartDec 1, 2004
Primary CompletionJun 1, 2009
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 20.8 years ago

Interventions

Velcadedrug

Induction: 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13 \& 14. Maintenance: 1.3 mg/m2 IV day 1 weekly x 2 weeks beginning week 20 and continuing every 6 months until month 23.

Rituximabdrug

Induction: 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13 and 14 prior to Velcade administration. Maintenance: 375 mg/m2 day 1 weekly x 4 weeks.