CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Bevacizumab +2 moredrug
Likely dose
Bevacizumab 15 mg/kgfrom 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/NCT00401817
NCT00401817Phase 2Completed
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Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)

Weill Medical College of Cornell University·interventional·Posted Nov 22, 2006·Updated Oct 20, 2017

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Rituximab, and 1 other intervention for Untreated Mantle Cell Lymphoma. Completed, enrolled 11 participants across 2 sites.

Detailed Summary

Primary Objective 1\. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL). Secondary Objectives 1. To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL. 2. To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUntreated Mantle Cell Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 22, 2006
Enrollment StartNov 1, 2007
Primary CompletionJul 1, 2011
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 19.6 years ago

Interventions

Bevacizumabdrug

15 mg/kg on day 1 of each of 6 cycles

Rituximabdrug

Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles. The dose to be administered is: Rituximab: 375 mg/m2

CHOPdrug

Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7