CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Rituximab +2 moredrug
Likely dose
Rituximab 375 mg/m2from 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/NCT00633594
NCT00633594Phase 2Completed

Phase I/II Study Evaluating Rituximab, Lenalidomide, and Bortezomib in the First-Line or Second-Line Treatment of Patients With Mantle Cell Lymphoma

SCRI Development Innovations, LLC·interventional·Posted Mar 12, 2008·Updated Jan 31, 2017

In Brief

A Phase 2 clinical trial evaluating Rituximab, Bortezomib, and 1 other intervention for Mantle Cell Lymphoma. Completed, enrolled 39 participants across 7 sites.

Detailed Summary

This is a Phase I/II multicenter, open-label, dose-escalation study of rituximab, bortezomib, and lenalidomide in the first-line or second-line treatment of patients with Mantle Cell Lymphoma (MCL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 12, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2015
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 18.3 years ago

Interventions

Rituximabdrug

DL 1, DL 2, and DL 3: 375 mg/m2 IV Days 1, 8, and 15; Cycles 2-6: 375 mg/m2 IV Day 1 Same for DL-1.

Bortezomibdrug

DL 1, DL 2, and DL 3: 1.3 mg/m2 IV Days 1, 4, 8, and 11 Same for DL-1.

Lenalidomidedrug

DL 1: 15 mg PO daily Days 1-14 followed by 7 days of rest DL 2: 20 mg PO daily Days 1-14 followed by 7 days of rest DL 3: 25 mg PO daily Days 1-14 followed by 7 days of rest DL-1: 10 mg PO daily Days 1-14 followed by 7 days of rest