Lenalidomide as Immune Adjuvant in Patient's With Chronic Lymphocytic Leukemia (CLL)
|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.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Disorder||Drug: Lenalidomide Biological: Influenza Vaccine Biological: Pneumovax Vaccine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Immune-adjuvant Effect of Lenalidomide in Patients With Chronic Lymphocytic Leukemia and Hypogammaglobulinemia and Impaired Response to Vaccinations - RV-CL-CLL-PI-002544|
|Actual Study Start Date :||November 24, 2014|
|Actual Primary Completion Date :||February 21, 2017|
|Actual Study Completion Date :||February 21, 2017|
Lenalidomide administered at the dose of 5 mg/day on Monday, Wednesday and Friday for 3 months. If Immunoglobulin G (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.
5 mg/day by mouth on Monday, Wednesday and Friday for 3 months. Process repeated for up to 2 years.
If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day by mouth 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.
Biological: Influenza Vaccine
Administered as injection yearly, during the fall/winter season.
Other Name: TIV
Biological: Pneumovax Vaccine
Administered by injection once between month 6 and month 21. Patients, who have received the Pneumovax vaccine within last 5 years, will not receive Pneumovax vaccination.
Other Name: Pneumonia vaccine
- Number of Participants With IgG Response [ Time Frame: 6 months ]IgG response defined as having improvement in IgG level by at least 25% at 6 months, compared to baseline.
- Seroconversion Response [ Time Frame: 4 weeks after flu vaccine administered ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924169
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Alessandra Ferrajoli, MD,BS||M.D. Anderson Cancer Center|