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Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00436618
First received: February 15, 2007
Last updated: July 24, 2013
Last verified: July 2013
Results First Received: May 1, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Lymphoproliferative Disorder
Intervention: Drug: Everolimus

  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
277 patients were accrued from 4 medical clinics in the United States between August 2005 and May 2010. One patient withdrew before starting treatment and thus excluded from the results.

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
Relapsed Aggressive Non-Hodgkin Lymphoma

Study 1.

Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Relapsed Indolent Non-Hodgkin Lymphoma

Study 2.

Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Uncommon Lymphomas

Study 3. Includes Hodgkin's lymphomas.

Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.


Participant Flow:   Overall Study
    Relapsed Aggressive Non-Hodgkin Lymphoma     Relapsed Indolent Non-Hodgkin Lymphoma     Uncommon Lymphomas  
STARTED     114     55     107  
COMPLETED     84     28     46  
NOT COMPLETED     30     27     61  
Withdrawal by Subject                 5                 8                 11  
Adverse Event                 8                 8                 9  
Alternate Treatment                 3                 4                 12  
Other Medical Problems                 3                 1                 7  
Death                 4                 2                 3  
New Primary or Other Reasons                 6                 2                 12  
Still on treatment                 1                 2                 7  



  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
Relapsed Aggressive Non-Hodgkin Lymphoma

Study 1.

Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Relapsed Indolent Non-Hodgkin Lymphoma

Study 2.

Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Uncommon Lymphomas

Study 3. Includes Hodgkin's lymphomas.

Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.

Total Total of all reporting groups

Baseline Measures
    Relapsed Aggressive Non-Hodgkin Lymphoma     Relapsed Indolent Non-Hodgkin Lymphoma     Uncommon Lymphomas     Total  
Number of Participants  
[units: participants]
  114     55     107     276  
Age  
[units: years]
Median ( Full Range )
  70  
  ( 36 to 92 )  
  67  
  ( 33 to 85 )  
  60  
  ( 20 to 85 )  
  66  
  ( 20 to 92 )  
Gender  
[units: participants]
       
Female     41     25     28     94  
Male     73     30     79     182  
Region of Enrollment  
[units: participants]
       
United States     114     55     107     276  
Hodgkin versus Non-Hodgkin Lymphoma  
[units: participants]
       
Hodgkin Lymphoma     0     0     29     29  
Non-Hodgkin Lymphoma     114     55     78     247  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tumor Response, Defined by Disease: Chronic Lymphocytic Leukemia(CLL): Clinical Complete or Complete or Nodular Partial or Partial Remission, Waldenstrom: Complete or Partial Response, All Others: Complete or Complete Unconfirmed or Partial Response.   [ Time Frame: 5 years ]

2.  Secondary:   Overall Survival   [ Time Frame: 5 years ]

3.  Secondary:   Progression-free Survival   [ Time Frame: 5 years ]

4.  Secondary:   Time to Progression   [ Time Frame: 5 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
No text entered.


  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: Thomas E. Witzig M.D.
Organization: Mayo Clinic
phone: (507) 284-0527
e-mail: witzig.thomas@mayo.edu


Publications of Results:

Responsible Party: Thomas E. Witzig, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00436618     History of Changes
Other Study ID Numbers: MC048G, P30CA015083, MC048G, 1042-05
Study First Received: February 15, 2007
Results First Received: May 1, 2013
Last Updated: July 24, 2013
Health Authority: United States: Food and Drug Administration