CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 164 enrolled
Drug / intervention
VELCADE +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01040871
NCT01040871Phase 2Completed
CompareCT.gov

A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Millennium Pharmaceuticals, Inc.·interventional·Posted Dec 30, 2009·Updated Jan 13, 2014

In Brief

A Phase 2 clinical trial evaluating VELCADE, Rituximab, and 4 other interventions for Diffuse Large B-Cell Lymphoma. Completed, enrolled 164 participants across 1 site.

Detailed Summary

This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B-Cell Lymphoma
CountriesBelgium
CollaboratorsJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 30, 2009
Enrollment StartJan 1, 2010
Primary CompletionJun 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.5 years ago

Interventions

VELCADEdrug

VELCADE intravenous on Days 1, 4, 8, and 11 of a 21 day (3 week) cycle for 6 cycles.

Rituximabdrug

Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Cyclophosphamidedrug

Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Doxorubicindrug

Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles

Prednisonedrug

Orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles

Vincristinedrug

Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles