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Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01281917
First Posted: January 24, 2011
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Millennium Pharmaceuticals, Inc.
Pfizer
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
Results First Submitted: June 20, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Hodgkins Lymphoma
Interventions: Drug: Velcade
Drug: Temsirolimus

  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
Patients with relapsed or refractory B-cell NHL were enrolled from 10 sites within the Wisconsin Oncology Network (WON) between May 2011 and May 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty participants were enrolled from 10 sites within the Wisconsin Oncology Network (WON) over 2 years. One participant withdrew consent immediately after enrollment and was never treated. Therefore, results are reported on the remaining 39 participants.

Reporting Groups
  Description
Velcade Plus Temsirolimus

Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)

Treat for up to 6 cycles, cycles are 35 days long.

Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)

Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)


Participant Flow:   Overall Study
    Velcade Plus Temsirolimus
STARTED   40 
COMPLETED   39 
NOT COMPLETED   1 
Withdrawal by Subject                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.
The study enrolled patients with relapsed and refractory B-cell non-Hodgkin lymphoma.

Reporting Groups
  Description
Velcade Plus Temsirolimus

Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)

Treat for up to 6 cycles, cycles are 35 days long.

Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)

Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)


Baseline Measures
   Velcade Plus Temsirolimus 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Median (Full Range)
 68 
 (38 to 89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  28.2% 
Male      28  71.8% 
Region of Enrollment 
[Units: Participants]
 
United States   39 
Number of prior treatments 
[Units: Prior treatments]
Median (Full Range)
 4 
 (1 to 11) 
Histology 
[Units: Participants]
Count of Participants
 
DLBCL      18  46.2% 
Follicular lymphoma      9  23.1% 
Mantle cell lymphoma      7  17.9% 
Small lymphocytic lymphoma      3   7.7% 
Marginal zone lymphoma      2   5.1% 
ECOG Performance Status [1] 
[Units: Participants]
Count of Participants
 
    17  43.6% 
    16  41.0% 
    6  15.4% 
[1] ECOG scales and criteria are used by doctors and researchers to assess how a patient's disease is progressing. Grade 0 is no affect to the daily living abilities of the patient, and Grade 5 is dead. This study was limited to participants with ECOG grades 0-2. Grade 0 is "Fully active, able to carry on all pre-disease performance without restriction," and Grade 2 is "Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours."


  Outcome Measures
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1.  Primary:   Overall Response Rate   [ Time Frame: Up to 60 months ]

2.  Primary:   Progression Free Survival   [ Time Frame: Up to 60 months ]

3.  Secondary:   Safety of This Regimen   [ Time Frame: Up to 36 months ]

4.  Secondary:   Complete Response Rate   [ Time Frame: Up to 60 months ]

5.  Secondary:   Tolerability of the Regimen   [ Time Frame: Up to 36 months ]

6.  Secondary:   Duration of Response   [ Time Frame: Up to 60 months ]

7.  Secondary:   Overall Survival   [ Time Frame: Up to 60 months ]


  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: Lymphoma Disease Oriented Team
Organization: University of Wisconsin Carbone Cancer Center
phone: 608-265-5542
e-mail: neils@wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01281917     History of Changes
Other Study ID Numbers: HO10407
H-2010-0393 ( Other Identifier: IRB )
First Submitted: January 20, 2011
First Posted: January 24, 2011
Results First Submitted: June 20, 2017
Results First Posted: August 21, 2017
Last Update Posted: August 21, 2017