CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 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/NCT00980395
NCT00980395Phase 2Completed

A Phase II, Open-Label Study of Bortezomib (Velcade), Cladribine and Rituximab (VCR) in Advanced, Newly Diagnosed and Relapsed/Refractory Mantle Cell and Indolent Lymphomas

University of Arizona·interventional·Posted Sep 21, 2009·Updated Dec 30, 2019

In Brief

A Phase 2 clinical trial evaluating rituximab, bortezomib, and 1 other intervention for Lymphoma and 3 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with cladribine and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with cladribine and rituximab works in treating patients with advanced mantle cell lymphoma or indolent lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2009
Enrollment StartJul 7, 2009
Primary CompletionSep 12, 2014
Study CompletionAug 14, 2018
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 16.8 years ago

Interventions

rituximabdrug

375 mg/m2 IV Day 1. Repeat every 28 days for a maximum of 6 cycles.

bortezomibdrug

1.3 mg/m2 IV Days 1 and 4. Repeat every 28 days for a maximum of 6 cycles.

cladribinedrug

4 mg/m2 IV over 2 hours Days 1-5. Repeat every 28 days for a maximum of 6 cycles.