MedTrace Logo

Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma

NCT00401817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-10-20

Study results available
· View outcomes & findings →

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.

Conditions

  • Untreated Mantle Cell Lymphoma

Interventions

DRUG

Bevacizumab

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

DRUG

Rituximab

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

DRUG

CHOP

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

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • John P Leonard, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-07-31
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00401817 on ClinicalTrials.gov