Bortezomib in Treating Patients With Lymphoproliferative Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00023764
First received: September 13, 2001
Last updated: February 17, 2014
Last verified: October 2013
Results First Received: October 23, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Intervention: Drug: bortezomib

  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
Protocol Open to Accrual 06/21/2001 Protocol Closed to Accrual 03/11/2008 Primary Completion Date 03/10/2009 Recruitment Location is the medical clinic

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
PS-341 (Bortezomib) Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.

Participant Flow:   Overall Study
    PS-341 (Bortezomib)  
STARTED     104  
COMPLETED     34  
NOT COMPLETED     70  
Not Treated                 1  
Unknown                 5  
Physician Decision                 8  
Lack of Efficacy                 4  
Adverse Event                 19  
Protocol Violation                 1  
Withdrawal by Subject                 4  
Progression of disease                 26  
patient received other treatment                 2  



  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
PS-341 (Bortezomib) Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.

Baseline Measures
    PS-341 (Bortezomib)  
Number of Participants  
[units: participants]
  104  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     36  
>=65 years     68  
Age  
[units: years]
Mean ± Standard Deviation
  60.5  ± 31.81980515  
Gender  
[units: participants]
 
Female     39  
Male     65  
Region of Enrollment  
[units: participants]
 
United States     103  
Jamaica     1  



  Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: Up to 3 years ]

2.  Secondary:   Duration of Response   [ Time Frame: Up to 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Progression Free Survival   [ Time Frame: Up to 3 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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


  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. John Gerecitano
Organization: Memorial Sloan-Kettering Cancer Center
phone: 212-639-3748
e-mail: gerecitj@mskcc.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00023764     History of Changes
Other Study ID Numbers: NCI-2012-01406, 01-049, N01CM62206, U01CA062502, CDR0000068860
Study First Received: September 13, 2001
Results First Received: October 23, 2013
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration