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

This study has been completed.
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Cephalon
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00547534
First received: October 18, 2007
Last updated: November 10, 2011
Last verified: November 2011
Results First Received: April 6, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Hodgkin's Lymphoma
Interventions: Drug: bortezomib
Drug: bendamustine
Drug: rituximab

  Participant Flow
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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
  Description
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]
NOT COMPLETED     11  
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
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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
  Description
Lymphoma Subjects Subjects that met all eligibility criteria and were given study treatment.

Baseline Measures
    Lymphoma Subjects  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     14  
Age  
[units: years]
Mean ± Standard Deviation
  64.8  ± 20  
Gender  
[units: participants]
 
Female     8  
Male     22  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures
  Show All 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
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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
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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
e-mail: Jonathan_Friedberg@urmc.rochester.edu


No publications provided by University of Rochester

Publications automatically indexed to this study:

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00547534     History of Changes
Other Study ID Numbers: ULYM07054
Study First Received: October 18, 2007
Results First Received: April 6, 2011
Last Updated: November 10, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board