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Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma

This study has been completed.
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Cephalon
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01029730
First received: December 8, 2009
Last updated: July 20, 2016
Last verified: July 2016
Results First Received: November 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Drug: Bendamustine
Drug: Bortezomib
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bendamustine/Bortezomib/Rituximab

Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.

Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles

Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles

Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1


Participant Flow for 2 periods

Period 1:   Combination Therapy
    Bendamustine/Bortezomib/Rituximab  
STARTED     55  
COMPLETED     39 [1]
NOT COMPLETED     16  
[1] Patients remained on-study until completing 6 cycles or coming off-treatment for any other reason

Period 2:   Maintenance Therapy
    Bendamustine/Bortezomib/Rituximab  
STARTED     37 [1]
COMPLETED     14  
NOT COMPLETED     23  
[1] Two patients complete study treatment but declined subsequent maintenance therapy



  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.
All enrolled patients

Reporting Groups
  Description
Bendamustine/Bortezomib/Rituximab

Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.

Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles

Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles

Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1


Baseline Measures
    Bendamustine/Bortezomib/Rituximab  
Number of Participants  
[units: participants]
  55  
Age  
[units: years]
Median (Full Range)
  64  
  (30 to 89)  
Gender  
[units: participants]
 
Female     27  
Male     28  
Region of Enrollment  
[units: participants]
 
United States     55  



  Outcome Measures
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1.  Primary:   Complete Response Rate   [ Time Frame: 18 months ]

2.  Secondary:   Overall Response Rate   [ Time Frame: At 3 and 6 months during treatment, then 6 months post-treatment. ]

3.  Secondary:   Median Progression-free Survival   [ Time Frame: at 3 and 6 months, then every 3 months post-treatment for 1 year and every 6 months thereafter until disease progression; projected 2 years. ]

4.  Secondary:   Number of Participants With Adverse Events as a Measure of Safety.   [ Time Frame: Days 1,8, and 15 of each 28-day cycle for 6 months, then every 3 months for a year, projected 2 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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net



Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01029730     History of Changes
Other Study ID Numbers: SCRI LYM 66
Study First Received: December 8, 2009
Results First Received: November 19, 2015
Last Updated: July 20, 2016
Health Authority: United States: Food and Drug Administration