Trial Outcomes & Findings for Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age (NCT NCT01011894)

Last Updated: 2017-05-18

Results Overview

The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Complete Response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment), No constitutional symptoms, ANC \>/= 1,500/ul, platelets\> 100,000/ul, Hgb\>11gm/dl (untransfused); Partial Response (PR): \>50% decrease in peripheral blood lymphocyte count from the pre-treatment baseline value, reduction in lymphadenopathy, reduction in size of the liver and/or the spleen; Progressive Disease (PD): Characterized by at least one of the following: \> 50% increase in the sum of the products of at least 2 lymph nodes on at least 2 consecutive exams at least 2 weeks apart. At least 1 node must be \>/= to 2cm in size, Appearance of new palpable LN, \> 50% increase in size of liver or spleen determined by measurement below the respective costal

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

2 years

Results posted on

2017-05-18

Participant Flow

Protocol Open to Accrual 11/6/2009, Protocol Closed to Accrual 2/26/2013, Primary Completion Date 2/23/2016, Recruitment location is the medical clinic

Participant milestones

Participant milestones
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient \>/= 65 years old.
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia n=26 Participants This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient \>/= 65 years old.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	17 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	2 Participants n=5 Participants
Race (NIH/OMB) White	24 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

PRIMARY outcome

Timeframe: 2 years

Population: 20 participants had Stable Disease, 3 had Progression of Disease, 3 were not evaluable due to toxicity

Outcome measures

Outcome measures
Measure	Participants Receiving Lenalidomide n=26 Participants Patients with intermediate or high-risk chronic lymphocytic leukemia (≥ 65 years old) will receive lenalidomide until disease progression at the 20mg dose level (recognizing that progression at this dose requires non-protocol alternate therapy) or unacceptable toxicity.
Best Response Stable Disease	20 Participants
Best Response Progressive Disease	3 Participants
Best Response Not Evaluable	3 Participants

Adverse Events

Intermediate or High Risk Chronic Lymphocytic Leukemia

Serious events: 11 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia n=26 participants at risk This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient \>/= 65 years old.
Blood and lymphatic system disorders ALT, SGPT	3.8% 1/26
Metabolism and nutrition disorders Creatinine increased	3.8% 1/26
General disorders Dizziness	3.8% 1/26
General disorders Fatigue	11.5% 3/26
General disorders Febrile neutropenia	3.8% 1/26
General disorders Headache	3.8% 1/26
Skin and subcutaneous tissue disorders Skin infection	3.8% 1/26
General disorders Pneumonia	15.4% 4/26
Respiratory, thoracic and mediastinal disorders Lung infection	11.5% 3/26
Blood and lymphatic system disorders Platelet count decreased	3.8% 1/26
Cardiac disorders Thrombosis/thrombus/embolism	3.8% 1/26

Other adverse events

Other adverse events
Measure	Intermediate or High Risk Chronic Lymphocytic Leukemia n=26 participants at risk This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient \>/= 65 years old.
Investigations Neutrophil count decreased	73.1% 19/26
Investigations Platelet count decreased	38.5% 10/26
Investigations Aspartate aminotransferase increased	15.4% 4/26
Blood and lymphatic system disorders Anemia	11.5% 3/26
Investigations Alanine aminotransferase increased	11.5% 3/26
Metabolism and nutrition disorders Hyperglycemia	11.5% 3/26
Investigations INR increased	7.7% 2/26
Metabolism and nutrition disorders Hypophosphatemia	7.7% 2/26
Metabolism and nutrition disorders Hyperkalemia	7.7% 2/26
Vascular disorders Thromboembolic event	7.7% 2/26

Additional Information

Dr. Renier Brentjens

Memorial Sloan Kettering Cancer Center

Phone: 212-639-7053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place