CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 487 enrolled
Drug / intervention
Rituximab 375 mg/m^2 +5 moredrug
Likely dose
Rituximab 375 mg/m^2from 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/NCT00722137
NCT00722137Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Multicenter Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone (VcR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Mantle Cell Lymphoma Who Are Not Eligible for a Bone Marrow Transplant

Millennium Pharmaceuticals, Inc.·interventional·Posted Jul 25, 2008·Updated Jul 12, 2018

In Brief

A Phase 3 clinical trial evaluating Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, and 4 other interventions for Mantle Cell Lymphoma. Completed, enrolled 487 participants across 150 sites in 29 countries.

Detailed Summary

This is a randomized, open-label, multicenter, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMantle Cell Lymphoma
CountriesAustria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Germany, Hungary, India, Israel, Italy, Malaysia, Morocco, Philippines, Poland, Portugal, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye), Ukraine, United States
CollaboratorsJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2008
Enrollment StartMay 1, 2008
Primary CompletionJan 1, 2014
Study CompletionJun 17, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 17.9 years ago

Interventions

Rituximab 375 mg/m^2drug

Intravenous rituximab 375 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles.

Cyclophosphamide 750 mg/m^2drug

Intravenous cyclophosphamide 750 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles

Doxorubicin 50 mg/m^2drug

Intravenous doxorubicin 50 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles

VELCADE 1.3 mg/m^2drug

Intravenous VELCADE 1.3 mg/m\^2 on Days 1,4,8, and 11of a 21-day (3 week) cycle for 6 cycles

Prednisone 100 mg/m^2drug

Oral prednisone 100 mg/m\^2 on Day 1 to Day 5 of a 21-day (3 week) cycle for 6 cycles

Vincristine 1.4 mg/m^2drug

Intravenous vincristine 1.4 mg/m\^2 on Day 1of a 21-day (3 week) cycle for 6 cycles. Maximum of 2 mg. Participants could receive 8 cycles if a response was initially documented at the Cycle 6 assessment.