CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Bortezomib +4 moredrug
Likely dose
Bortezomib 1.3 mgfrom 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/NCT00958256
NCT00958256Phase 2Completed

Phase II Study of Bortezomib in Combination With Cyclophosphamide and Rituximab for Relapsed/Refractory Mantle Cell Lymphoma

M.D. Anderson Cancer Center·interventional·Posted Aug 13, 2009·Updated Apr 13, 2015

In Brief

A Phase 2 clinical trial evaluating Bortezomib, Rituximab, and 3 other interventions for Mantle Cell Lymphoma and Lymphoma. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if bortezomib when given in combination with cyclophosphamide and rituximab can help to control mantle cell lymphoma. The safety of this drug combination will also continue to be studied.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 13, 2009
Enrollment StartAug 1, 2009
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 16.9 years ago

Interventions

Bortezomibdrug

Bortezomib 1.3 mg/m\^2 given intravenously over 3-5 seconds at the end of infusion of Rituximab on Day 1 of every cycle, then on Days 4, 8 and 11 of every cycle.

Rituximabdrug

375 mg/m\^2 given intravenously over 6-8 hours on Day 1 of every 21-day study cycle.

Cyclophosphamidedrug

300 mg/m\^2 intravenously over 3 hours 2 times each day (6 hours total each day) on Days 2, 3, and 4 of every cycle

Mesnadrug

600 mg/m\^2 intravenous continuous infusion (IVCI) over 24 hours daily for 3 days, 1 hour prior to Cyclophosphamide and complete by 12 hours after last dose of Cyclophosphamide.

G-CSFdrug

5 micrograms/kg subcutaneously daily starting 24-36 hours for 7 days after last dose of Bortezomib until granulocytes are more than 4 x 103/dl.