Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

This study has been terminated.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00850499
First received: February 24, 2009
Last updated: December 10, 2012
Last verified: December 2012
Results First Received: October 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Follicular Lymphoma
Interventions: Drug: fludarabine
Drug: rituximab
Drug: VELCADE

  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
Velcade + Fludarabine No text entered.
Rituximab + Fludarabine No text entered.

Participant Flow:   Overall Study
    Velcade + Fludarabine     Rituximab + Fludarabine  
STARTED     4     8  
COMPLETED     1     6  
NOT COMPLETED     3     2  
Adverse Event                 3                 1  
Lack of Efficacy                 0                 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.
No text entered.

Reporting Groups
  Description
Velcade + Fludarabine No text entered.
Rituximab + Fludarabine No text entered.
Total Total of all reporting groups

Baseline Measures
    Velcade + Fludarabine     Rituximab + Fludarabine     Total  
Number of Participants  
[units: participants]
  4     8     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     6     9  
>=65 years     1     2     3  
Age  
[units: years]
Mean ± Standard Deviation
  61.3  ± 12.84     60.0  ± 10.06     60.4  ± 10.47  
Gender  
[units: participants]
     
Female     2     3     5  
Male     2     5     7  
Region of Enrollment  
[units: participants]
     
France     0     3     3  
Greece     0     1     1  
Spain     1     0     1  
Israel     1     0     1  
Germany     0     1     1  
Switzerland     1     0     1  
Italy     1     3     4  



  Outcome Measures
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1.  Primary:   Complete Response Rate   [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ]

2.  Secondary:   Overall Response Rate   [ Time Frame: Up to 8 cycles (1 cycle is 35 days: 280 days) ]


  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
Early termination leading to small numbers of subjects analyzed


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Andrew Cakana, MD, FRC Path
Organization: Johnson & Johnson Pharmaceutical Research & Development
e-mail: [ACAKANA@ITS.JNJ.COM


No publications provided


Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00850499     History of Changes
Other Study ID Numbers: 26866138-LYM-2033
Study First Received: February 24, 2009
Results First Received: October 3, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration