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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:
ClinicalTrials.gov Identifier:
NCT00436618
First Posted: February 19, 2007
Last Update Posted: July 30, 2013
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
Results First Submitted: May 1, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thomas E. Witzig, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00436618     History of Changes
Other Study ID Numbers: MC048G
P30CA015083 ( U.S. NIH Grant/Contract )
MC048G ( Other Identifier: Mayo Clinic Cancer Cancer )
1042-05 ( Other Identifier: Mayo Clinic IRB )
First Submitted: February 15, 2007
First Posted: February 19, 2007
Results First Submitted: May 1, 2013
Results First Posted: July 30, 2013
Last Update Posted: July 30, 2013