Trial Outcomes & Findings for Lenalidomide in Improving Immune Response to Vaccine Therapy in Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Monoclonal B Cell Lymphocytosis (NCT NCT02309515)

Last Updated: 2021-01-19

Results Overview

Rate of response to pneumococcal 13-valent conjugate vaccine defined as a four-fold rise from baseline to 28 days after immunization (day 43) for \>= 2 of the 3 serotypes studied by OPA of antibodies from sera. The proportion of successes will be estimated in each arm by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated in each arm based on the normal approximation.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Day 43

Results posted on

2021-01-19

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine) Patients receive 2.5 mg lenalidomide PO QD on days 1-14 and 5 mg lenalidomide PO QD on days 15-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.	Arm II (Pneumococcal 13-valent Conjugate Vaccine) Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.
Overall Study STARTED	5	7
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine) Patients receive 2.5 mg lenalidomide PO QD on days 1-14 and 5 mg lenalidomide PO QD on days 15-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.	Arm II (Pneumococcal 13-valent Conjugate Vaccine) Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Lenalidomide in Improving Immune Response to Vaccine Therapy in Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Monoclonal B Cell Lymphocytosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine) n=5 Participants Patients receive 2.5 mg lenalidomide PO QD on days 1-14 and 5 mg lenalidomide PO QD on days 15-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.	Arm II (Pneumococcal 13-valent Conjugate Vaccine) n=7 Participants Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.	Total n=12 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	60 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 43

Population: All patients that were registered and assessed for this endpoint are included in this analysis

Outcome measures

Outcome measures
Measure	Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine) n=5 Participants Patients receive 2.5 mg lenalidomide PO QD on days 1-14 and 5 mg lenalidomide PO QD on days 15-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.	Arm II (Pneumococcal 13-valent Conjugate Vaccine) n=6 Participants Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.
Proportion of Participants With Successful Response	0.2 proportion of participants Interval 0.005 to 0.716	0.0 proportion of participants Interval 0.0 to 0.46

SECONDARY outcome

Timeframe: At 6 weeks

Population: All patients that registered and were assessed for response were included in this endpoint.

The distribution of disease status will be evaluated in each arm and will be summarized descriptively. Patients will be classified as responders (complete clinical response, incomplete marrow recovery, partial response) vs. non-responders (stable disease, progressive disease \[PD\]). For MBL, patients will be classified as not PD vs PD. Differences in disease status response will be compared between the two arms using Fisher's exact test.

Outcome measures

Outcome measures
Measure	Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine) n=5 Participants Patients receive 2.5 mg lenalidomide PO QD on days 1-14 and 5 mg lenalidomide PO QD on days 15-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.	Arm II (Pneumococcal 13-valent Conjugate Vaccine) n=6 Participants Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.
Disease Status by Physical Exam and Complete Blood Counts Responder	1 Participants	0 Participants
Disease Status by Physical Exam and Complete Blood Counts Non-responder	4 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to day 50

Population: All patients that received protocol treatment are included in this analysis.

Adverse Events were collected during treatment according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient. The worst grade per patient is presented below.

Outcome measures

Outcome measures
Measure	Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine) n=5 Participants Patients receive 2.5 mg lenalidomide PO QD on days 1-14 and 5 mg lenalidomide PO QD on days 15-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.	Arm II (Pneumococcal 13-valent Conjugate Vaccine) n=6 Participants Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.
Incidence of Adverse Events Using NCI Common Terminology Criteria for Adverse Events Version 4.0 Grade 2	0 Participants	0 Participants
Incidence of Adverse Events Using NCI Common Terminology Criteria for Adverse Events Version 4.0 Grade 3	0 Participants	0 Participants
Incidence of Adverse Events Using NCI Common Terminology Criteria for Adverse Events Version 4.0 Grade 0	2 Participants	3 Participants
Incidence of Adverse Events Using NCI Common Terminology Criteria for Adverse Events Version 4.0 Grade 1	3 Participants	3 Participants
Incidence of Adverse Events Using NCI Common Terminology Criteria for Adverse Events Version 4.0 Grade 4	0 Participants	0 Participants
Incidence of Adverse Events Using NCI Common Terminology Criteria for Adverse Events Version 4.0 Grade 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Time from the date of registration to the date of initiation of treatment for progressive CLL assessed up to 2 years

Population: The study was terminated prior to the collection of any subsequent treatment for CLL. Therefore, no patients were eligible for this endpoint and this analysis was not performed.

The distribution of time to treatment will be estimated in each arm using the method of Kaplan-Meier. Time to treatment will be compared between the two arms using log-rank statistics.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Arm II (Pneumococcal 13-valent Conjugate Vaccine)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I (Lenalidomide, Pneumococcal 13-valent Conjugate Vaccine) n=5 participants at risk Patients receive 2.5 mg lenalidomide PO QD on days 1-14 and 5 mg lenalidomide PO QD on days 15-42 and pneumococcal 13-valent conjugate vaccine IM on day 15.	Arm II (Pneumococcal 13-valent Conjugate Vaccine) n=6 participants at risk Patients receive pneumococcal 13-valent conjugate vaccine IM on day 15.
Blood and lymphatic system disorders Anemia	0.00% 0/5 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.	50.0% 3/6 • Number of events 5 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.
General disorders Fatigue	40.0% 2/5 • Number of events 3 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.	33.3% 2/6 • Number of events 3 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.
Investigations Neutrophil count decreased	20.0% 1/5 • Number of events 1 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.	0.00% 0/6 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.
Investigations Platelet count decreased	40.0% 2/5 • Number of events 4 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.	33.3% 2/6 • Number of events 4 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.
Investigations White blood cell decreased	20.0% 1/5 • Number of events 1 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.	0.00% 0/6 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	40.0% 2/5 • Number of events 3 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.	0.00% 0/6 • Adverse events were collected during one 50 day cycle of treatment. Adverse events were collected during one 50 day cycle of treatment.

Additional Information

Tait D. Shanafelt, MD

Mayo Clinic

Phone: 507.284.2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place