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Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL

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ClinicalTrials.gov Identifier: NCT00772668
Recruitment Status : Terminated (Funding)
First Posted : October 15, 2008
Results First Posted : February 21, 2013
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Denise Pereira, University of Miami

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lymphoma
Follicular Lymphoma
Marginal Zone Lymphoma
Interventions: Drug: Rituximab
Drug: Bortezomib
Drug: Cyclophosphamide
Drug: Prednisone

  Participant Flow

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

Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):

  • Rituximab

    • Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles
    • Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles
  • Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles
  • Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles
  • Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles

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



  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
  Description
RCVELP

Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):

  • Rituximab

    • Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles
    • Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles
  • Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles
  • Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles
  • Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles

Baseline Measures
   RCVELP 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      3 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  66.7% 
Male      1  33.3% 
Region of Enrollment 
[Units: Participants]
 
United States   3 


  Outcome Measures

1.  Primary:   Overall Response Rate, According to the International Workshop Criteria (IWC) for Non-Hodgkin's Lymphoma (NHL)   [ Time Frame: Post cycles 2,4,6,8 and then every 3 months, about 2 years ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 5 years ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 5 years ]

4.  Secondary:   Rate of Toxicity in Study Participants   [ Time Frame: Up to 5 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
This study was terminated early due to lack of funding. All patients were removed from the study.


  More Information

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



Responsible Party: Denise Pereira, University of Miami
ClinicalTrials.gov Identifier: NCT00772668     History of Changes
Other Study ID Numbers: 20070963
SCCC-2006120 ( Other Identifier: UM/Sylvester Comprehensive Cancer Center )
First Submitted: October 12, 2008
First Posted: October 15, 2008
Results First Submitted: January 18, 2013
Results First Posted: February 21, 2013
Last Update Posted: December 11, 2017