CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
Bortezomib, CHOP, Rituximabdrug
Likely dose
Bortezomib (dose to be determined) with CHOP (full dose every 21 days) and rituximab (375 mg/m2 day 1 of each cycle) for 6 cyclesAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed diffuse large B-cell or mantle cell non-Hodgkin's lymphoma with appropriate immunophenotype
  • ✓No prior anti-cancer therapy for lymphoma
  • ✓CD20 antigen expression on tumor tissue
  • ✓Measurable disease with tumor mass >1.5 cm
Key exclusion· 5
  • ✕Central nervous system involvement by lymphoma
  • ✕HIV disease
  • ✕Pregnancy or nursing
  • ✕Major surgery within 3 weeks

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

Search/NCT00151320
NCT00151320Phase 2Completed
CompareCT.gov

Phase I/II Trial of VELCADE+ CHOP-Rituximab in Patients With Previously Untreated Diffuse Large B Cell or Mantle Cell Non-Hodgkin's Lymphoma

Weill Medical College of Cornell University·interventional·Posted Sep 8, 2005·Updated Jun 19, 2018

In Brief

A Phase 2 clinical trial evaluating Bortezomib, CHOP, Rituximab for Non-Hodgkin's Lymphoma. Completed, enrolled 76 participants across 4 sites.

Detailed Summary

Primary Objective: To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when administered in combination with CHOP + Rituximab to patients with previously untreated diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL) Secondary Objectives: To assess the response rate (overall and complete), event-free survival and overall survival with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle cell lymphoma (phase II component) Treatment: Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications) VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule: Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartJan 1, 2004
Primary CompletionApr 1, 2010
Study CompletionApr 24, 2013
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 20.8 years ago

Interventions

Bortezomib, CHOP, Rituximabdrug

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications) VELCADE (Bortezomib) is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule: Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4