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Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00935792
First received: July 6, 2009
Last updated: October 19, 2016
Last verified: January 2016
Results First Received: April 29, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphocytic Leukemia
Interventions: Drug: alemtuzumab
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Phase 1, Dose Level 1 Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
Phase 1, Dose Level 2 Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
Phase 2, Dose Level 1 Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.

Participant Flow:   Overall Study
    Phase 1, Dose Level 1   Phase 1, Dose Level 2   Phase 2, Dose Level 1
STARTED   7   9   12 
COMPLETED   6   6   12 
NOT COMPLETED   1   3   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.
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Reporting Groups
  Description
Phase 1, Dose Level 1 Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
Phase 1, Dose Level 2 Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
Phase 2, Dose Level 1 Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Phase 1, Dose Level 1   Phase 1, Dose Level 2   Phase 2, Dose Level 1   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12   24 
Age 
[Units: Years]
Median (Full Range)
 72.5 
 (66 to 78) 
 73 
 (54 to 82) 
 71 
 (61 to 82) 
 72 
 (54 to 82) 
Gender 
[Units: Participants]
       
Female   4   4   4   12 
Male   2   2   8   12 
Region of Enrollment 
[Units: Participants]
       
United States   6   6   12   24 
Previouse number of regimens 
[Units: Regimens]
Median (Full Range)
 2 
 (1 to 6) 
 3.5 
 (1 to 5) 
 3 
 (1 to 10) 
 3 
 (1 to 10) 


  Outcome Measures
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1.  Primary:   Clinical Response (Complete or Partial Remission)   [ Time Frame: After 2 courses of treatment ]

2.  Primary:   Number of Participants With Dose-Limiting Toxicities   [ Time Frame: 1 Month ]

3.  Primary:   Test the Safety and Tolerability of the Combination of Everolimus and Alemtuzumab.   [ Time Frame: Up to 12 months past final treatment ]

4.  Secondary:   Survival Time   [ Time Frame: up to 5 years ]

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

6.  Secondary:   Duration of Response   [ Time Frame: up to 5 years ]

7.  Secondary:   Time to Subsequent Therapy   [ Time Frame: up to 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
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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: Timothy Call, M.D.
Organization: Mayo Clinic
phone: 5076682050
e-mail: Call.Timothy@mayo.edu



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00935792     History of Changes
Other Study ID Numbers: MC088C
MC088C ( Other Identifier: Mayo Clinic Cancer Center )
NCI-2009-00935 ( Registry Identifier: NCI's CTRO )
08-008775 ( Other Identifier: Mayo Clinic IRB )
Study First Received: July 6, 2009
Results First Received: April 29, 2016
Last Updated: October 19, 2016