Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma (BVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00547534
Recruitment Status : Completed
First Posted : October 22, 2007
Results First Posted : June 6, 2011
Last Update Posted : August 6, 2015
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jonathan Friedberg, University of Rochester

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Hodgkin's Lymphoma
Interventions: Drug: bortezomib
Drug: bendamustine
Drug: rituximab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment at the University of Rochester Medical Center, Weill Cornell Medical Center and the University of Nebraska began in October 2007 and ended in March 2009. Patients were recruited in a medial clinic setting.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Lymphoma Subjects Subjects that met all eligibility criteria and were given study treatment.

Participant Flow:   Overall Study
    Lymphoma Subjects
STARTED   30 [1] 
COMPLETED   19 [2] 
Adverse Event                7 
Disease Progression                4 
[1] 31 patients enrolled; one patient was determined to be ineligible, and did not receive any therapy.
[2] 25 patients received at least 4 cycles. 29 patients were evaluable for response.

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Lymphoma Subjects Subjects that met all eligibility criteria and were given study treatment.

Baseline Measures
   Lymphoma Subjects 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   16 
>=65 years   14 
[Units: Years]
Mean (Standard Deviation)
 64.8  (20) 
[Units: Participants]
Female   8 
Male   22 
Region of Enrollment 
[Units: Participants]
United States   30 

  Outcome Measures

1.  Primary:   Number of Participants With Progression Free Survival at 2 Years   [ Time Frame: Two years ]

2.  Secondary:   Toxicity of Drug Combination in the Subjects   [ Time Frame: Two years ]

3.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Two years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
19 patients received a full 6 cycles of therapy. All patients received at least one cycle of therapy, 25 patients received at least 4 cycles. Reasons for early termination included progressive disease and toxicity

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Jonathan Friedberg
Organization: University of Rochester Medical Center
phone: 585-275-4911

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Jonathan Friedberg, University of Rochester Identifier: NCT00547534     History of Changes
Other Study ID Numbers: ULYM07054
First Submitted: October 18, 2007
First Posted: October 22, 2007
Results First Submitted: April 6, 2011
Results First Posted: June 6, 2011
Last Update Posted: August 6, 2015