CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00290472
First received: February 10, 2006
Last updated: May 7, 2014
Last verified: February 2013
Results First Received: August 19, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: B-cell Chronic Lymphocytic Leukemia
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Malignant Neoplasm
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
Intervention: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient never received protocol treatment and was excluded from analysis.

Reporting Groups
  Description
Aggressive B-cell Lymphoma Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
Follicular Lymphoma Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
Chronic Lymphocytic Leukemia Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.

Participant Flow:   Overall Study
    Aggressive B-cell Lymphoma     Follicular Lymphoma     Chronic Lymphocytic Leukemia  
STARTED     32     39     18  
COMPLETED     32     39     18  
NOT COMPLETED     0     0     0  



  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
Aggressive B-cell Lymphoma Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
Follicular Lymphoma Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
Chronic Lymphocytic Leukemia Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
Total Total of all reporting groups

Baseline Measures
    Aggressive B-cell Lymphoma     Follicular Lymphoma     Chronic Lymphocytic Leukemia     Total  
Number of Participants  
[units: participants]
  32     39     18     89  
Age  
[units: years]
Median ( Full Range )
  67  
  ( 30 to 87 )  
  59  
  ( 28 to 75 )  
  57  
  ( 38 to 82 )  
  61  
  ( 28 to 87 )  
Gender  
[units: participants]
       
Female     15     15     7     37  
Male     17     24     11     52  



  Outcome Measures
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1.  Primary:   Objective Overall Response Rate   [ Time Frame: Up to 6 years ]

2.  Primary:   Duration of Response   [ Time Frame: Up to 6 years ]

3.  Primary:   Overall Survival   [ Time Frame: Up to 6 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sonali M. Smith
Organization: University of Chicago Comprehensive Cancer Center
phone: 7738342895
e-mail: smsmith@medicine.bsd.uchicago.edu


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00290472     History of Changes
Obsolete Identifiers: NCT00084474
Other Study ID Numbers: NCI-2009-00047, NCI-2009-00047, CDR0000365314, NCI-6199, 12983A, 6199, 6199, N01CM62201, N01CM62202, P30CA014599
Study First Received: February 10, 2006
Results First Received: August 19, 2013
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration