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A Phase I/II Trial of VR-CHOP in Lymphoma Patients

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Christopher R. Flowers, Emory University
ClinicalTrials.gov Identifier:
NCT00634179
First received: February 11, 2008
Last updated: September 21, 2016
Last verified: September 2016
Results First Received: February 17, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma, B-Cell
Follicular Lymphoma
Interventions: Drug: Bortezomib
Biological: Rituximab
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Vincristine
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
All patients were recruited from Winship Cancer Institute of Emory University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 37 patients were enrolled. However, not all patients participated in both phases of this study. For phase I, 19 patients were enrolled, and for phase II, 30 patients were enrolled.

Reporting Groups
  Description
Treatment (VR-CHOP Regimen)

Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy regimen.

In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-cell non-Hodgkin's lymphoma (B-NHL)(Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma.


Participant Flow for 2 periods

Period 1:   Phase I: Induction
    Treatment (VR-CHOP Regimen)
STARTED   19 
COMPLETED   19 
NOT COMPLETED   0 

Period 2:   Phase II: Maintenance
    Treatment (VR-CHOP Regimen)
STARTED   30 
COMPLETED   29 
NOT COMPLETED   1 
Diagnosis changed after re-review                1 



  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.
A total of 37 patients were enrolled on this study. However, not all patients participated in both phases of this study. For phase I, 19 patients were enrolled, and for phase II, 30 patients were enrolled.

Reporting Groups
  Description
Treatment (VR-CHOP Regimen)

INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.

MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.


Baseline Measures
   Treatment (VR-CHOP Regimen) 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Years]
Median (Full Range)
 58 
 (28 to 71) 
Gender 
[Units: Participants]
 
Female   17 
Male   20 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   11 
White   26 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   37 


  Outcome Measures
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1.  Primary:   Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I)   [ Time Frame: Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks ]

2.  Secondary:   An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria   [ Time Frame: Following completion of therapy, up to 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Christopher R. Flowers, MD, MS
Organization: Emory University
phone: 404-778-3935
e-mail: crflowe@emory.edu


Publications of Results:

Responsible Party: Christopher R. Flowers, Emory University
ClinicalTrials.gov Identifier: NCT00634179     History of Changes
Other Study ID Numbers: IRB00002996
X05215 ( Other Identifier: Winship Cancer Institute )
Study First Received: February 11, 2008
Results First Received: February 17, 2016
Last Updated: September 21, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board