Trial Outcomes & Findings for Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL) (NCT NCT00860457)

Results Overview

Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be \< 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

3 years

Results posted on

2018-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy Fludarabine/Rituximab followed by Lenalidomide
Overall Study STARTED	22
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy n=22 Participants Fludarabine/Rituximab followed by Lenalidomide Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles
Age, Continuous	60.5 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be \< 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent.

Outcome measures

Outcome measures
Measure	Chemotherapy n=22 Participants Fludarabine/Rituximab followed by Lenalidomide Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles
Complete Response Rate	36 percentage of patients

Adverse Events

Chemotherapy

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy n=22 participants at risk Fludarabine/Rituximab followed by Lenalidomide Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles
Blood and lymphatic system disorders Fatal septic shock secondary to bacteremia	4.5% 1/22

Other adverse events

Other adverse events
Measure	Chemotherapy n=22 participants at risk Fludarabine/Rituximab followed by Lenalidomide Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles
Blood and lymphatic system disorders grade 3/4 neutropenia	59.1% 13/22
Blood and lymphatic system disorders grade 1/2 anemia	54.5% 12/22
Blood and lymphatic system disorders grade 3/4 anemia	18.2% 4/22
Blood and lymphatic system disorders grade 1/2 neutropenia	9.1% 2/22
Blood and lymphatic system disorders grade 1/2 thrombocytopenia	9.1% 2/22
Blood and lymphatic system disorders grade 3/4 thrombocytopneia	18.2% 4/22

Additional Information

Dr. Bruce D. Cheson

Lombardi Comprehensive Cancer Center, Georgetown University Hospital

Phone: 202-444-7932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place