CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
Bortezomib +7 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/NCT00477412
NCT00477412Phase 2Completed

Phase I/II Study of Bortezomib (VELCADE) Plus Rituximab-HyperCVAD Alternating With Bortezomib Plus Rituximab-High Dose Methotrexate/Cytarabine in Patients With Untreated Aggressive Mantle Cell Lymphoma

M.D. Anderson Cancer Center·interventional·Posted May 23, 2007·Updated Jan 28, 2022

In Brief

A Phase 2 clinical trial evaluating Bortezomib, Cyclophosphamide, and 6 other interventions for Mantle Cell Lymphoma. Completed, enrolled 107 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and best dose of bortezomib when given with rituximab and chemotherapy drugs and to see how well they work in treating participants with mantle cell lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bortezomib, rituximab and combination chemotherapy may work better at treating mantle cell lymphoma.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 23, 2007
Enrollment StartApr 3, 2007
Primary CompletionOct 28, 2020
TodayJul 2, 2026
Enrollment to primary: 13.6 yearsPosted 19.1 years ago

Interventions

Bortezomibdrug

Given IV

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IV

Dexamethasonedrug

Given PO or IV

Doxorubicindrug

Given IV

Methotrexatedrug

Given IV

Rituximabbiological

Given IV

Vincristinedrug

Given IV