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Lenalidomide as Immune Adjuvant in Patient's With Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT01924169
Recruitment Status : Terminated (Slow Accrual)
First Posted : August 16, 2013
Results First Posted : March 27, 2018
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Hematologic Disorder
Interventions Drug: Lenalidomide
Biological: Influenza Vaccine
Biological: Pneumovax Vaccine
Enrollment 3
Recruitment Details November 2014 through May 2016. All of the participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Lenalidomide
Hide Arm/Group Description

Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If Immunoglobulin G (IgG) levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.

Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21.

Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Lenalidomide
Hide Arm/Group Description

Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.

Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  33.3%
>=65 years
2
  66.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants
65
(48 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
 100.0%
1.Primary Outcome
Title Number of Participants With IgG Response
Hide Description IgG response defined as having improvement in IgG level by at least 25% at 6 months, compared to baseline.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide
Hide Arm/Group Description:

Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.

Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21.

Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Seroconversion Response
Hide Description Study considered positive in regard to the secondary endpoints if seroconversion is observed in 60% or more of the subjects for at least one of the vaccinations given.
Time Frame 4 weeks after flu vaccine administered
Hide Outcome Measure Data
Hide Analysis Population Description
The first three participants did not remain on study long enough to undergo immunizations.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:

Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.

Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description

Lenalidomide administered at the dose of 5 mg/day three times a day for three months. If IgG levels improve by at least 25% of baseline, lenalidomide administration continued for 3 months on, and 3 months off for 2 years. If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.

Seasonal influenza vaccination (Trivalent Influenza Vaccine, Fluzone High Dose) administered yearly, during the fall/winter season and pneumococcal immunization (Pneumococcal Polysaccharide Vaccine, Pneumovax) administered once between month 6 and month 21.

All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%) # Events
Total   2/3 (66.67%)    
Cardiac disorders   
Chest Pain  1  1/3 (33.33%)  1
Gastrointestinal disorders   
Diarrhea  1  1/3 (33.33%)  1
Vomiting  1  1/3 (33.33%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Gastrointestinal disorders   
Constipation  1  1/3 (33.33%)  1
General disorders   
Fatigue/Malaise  1  1/3 (33.33%)  1
Infections and infestations   
Pneumonia  1  1/3 (33.33%)  1
Nervous system disorders   
insomnia  1  1/3 (33.33%)  1
Skin and subcutaneous tissue disorders   
rash  1  1/3 (33.33%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alessandra Ferrajoli, MD/Professor
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-792-7734
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01924169     History of Changes
Other Study ID Numbers: 2013-0371
NCI-2014-01058 ( Registry Identifier: NCI CTRP )
First Submitted: August 13, 2013
First Posted: August 16, 2013
Results First Submitted: February 9, 2018
Results First Posted: March 27, 2018
Last Update Posted: September 20, 2018