Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Treating Patients With Stage III or Stage IV Follicular Lymphoma or Marginal Zone Lymphoma

This study has been terminated.
(Funding)
Sponsor:
Information provided by (Responsible Party):
University of Miami
ClinicalTrials.gov Identifier:
NCT00772668
First received: October 12, 2008
Last updated: August 13, 2013
Last verified: August 2013
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Drug: Rituximab
Drug: Bortezomib
Drug: Cyclophosphamide
Drug: Prednisone

  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
No text entered.

Reporting Groups
  Description
RCVELP

Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles

Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles

Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles

Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles


Participant Flow:   Overall Study
    RCVELP  
STARTED     3  
COMPLETED     0  
NOT COMPLETED     3  
Physician Decision                 3  



  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
RCVELP

Bortezomib : 1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles

Cyclophosphamide : 750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles

Prednisone : 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles

Rituximab : 375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles


Baseline Measures
    RCVELP  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures

1.  Primary:   Overall Response Rate, According to the International Workshop Criteria (IWC)   [ Time Frame: 5 years ]

2.  Secondary:   Progression-free Survival as Assessed by RECIST Criteria   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Overall Survival   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Safety and Tolerance to Rituximab, Cyclophosphamide, Bortezomib, and Prednisone   [ Time Frame: 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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
This study was terminated early due to lack of funding. All patients were removed from the study. No results were analyzed.


  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: Denise Pereira MD
Organization: UM/Sylvester Comprehensive Cancer
phone: 305-243-9127
e-mail: dpereira2@med.miami.edu


No publications provided


Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT00772668     History of Changes
Other Study ID Numbers: UMIAMI-20070963, SCCC-2006120
Study First Received: October 12, 2008
Results First Received: January 18, 2013
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration