Trial Outcomes & Findings for Lenalidomide as Immune Adjuvant in Patient's With Chronic Lymphocytic Leukemia (CLL) (NCT NCT01924169)
NCT ID: NCT01924169
Last Updated: 2018-09-20
Results Overview
IgG response defined as having improvement in IgG level by at least 25% at 6 months, compared to baseline.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
6 months
Results posted on
2018-09-20
Participant Flow
November 2014 through May 2016. All of the participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Lenalidomide
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.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide as Immune Adjuvant in Patient's With Chronic Lymphocytic Leukemia (CLL)
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=3 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsIgG response defined as having improvement in IgG level by at least 25% at 6 months, compared to baseline.
Outcome measures
| Measure |
Lenalidomide
n=3 Participants
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.
|
|---|---|
|
Number of Participants With IgG Response
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeks after flu vaccine administeredPopulation: The first three participants did not remain on study long enough to undergo immunizations.
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.
Outcome measures
Outcome data not reported
Adverse Events
Lenalidomide
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide
n=3 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 6 months.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 6 months.
|
|
Cardiac disorders
Chest Pain
|
33.3%
1/3 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 6 months.
|
Other adverse events
| Measure |
Lenalidomide
n=3 participants at risk
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.
|
|---|---|
|
General disorders
Fatigue/Malaise
|
33.3%
1/3 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 6 months.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 6 months.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 6 months.
|
|
Nervous system disorders
insomnia
|
33.3%
1/3 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 6 months.
|
|
Skin and subcutaneous tissue disorders
rash
|
33.3%
1/3 • Number of events 1 • Participants will be assessed for adverse events from the first dose of study medication to the completion of study treatment, up to 6 months.
|
Additional Information
Alessandra Ferrajoli, MD/Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place