Trial Outcomes & Findings for Lirilumab With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients (NCT NCT02481297)
NCT ID: NCT02481297
Last Updated: 2020-05-28
Results Overview
Response is defined as complete remission (CR), complete remission with incomplete marrow recovery (CRi) or partial remission (PR) that occurs during the first 6 months of therapy. CR requires the absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts. CRi is Complete remission with incomplete bone marrow recovery. PR, defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
6 months
Results posted on
2020-05-28
Participant Flow
Recruitment Period: September 2015 to April 2016
Participant milestones
| Measure |
Cohort 1: Refractory/Relapsed After Prior Therapy
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
Cohort 2: Untreated With High-rRisk mMolecular Features
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
6
|
|
Overall Study
COMPLETED
|
1
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lirilumab With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients
Baseline characteristics by cohort
| Measure |
Cohort 1: Refractory/Relapsed After Prior Therapy
n=1 Participants
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
Cohort 2: Untreated With High-rRisk mMolecular Features
n=6 Participants
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
n=5 Participants
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsResponse is defined as complete remission (CR), complete remission with incomplete marrow recovery (CRi) or partial remission (PR) that occurs during the first 6 months of therapy. CR requires the absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts. CRi is Complete remission with incomplete bone marrow recovery. PR, defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts
Outcome measures
| Measure |
Cohort 1: Refractory/Relapsed After Prior Therapy
n=1 Participants
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
Cohort 2: Untreated With High-rRisk mMolecular Features
n=6 Participants
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
|---|---|---|
|
Participants With a Response
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsTime from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Cohort 1: Refractory/Relapsed After Prior Therapy
n=1 Participants
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
Cohort 2: Untreated With High-rRisk mMolecular Features
n=6 Participants
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
|---|---|---|
|
Overall Survival
|
6.3 Months
|
43.6 Months
Interval 30.7 to 48.1
|
SECONDARY outcome
Timeframe: Up to 4 yearsTime from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Cohort 1: Refractory/Relapsed After Prior Therapy
n=1 Participants
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
Cohort 2: Untreated With High-rRisk mMolecular Features
n=6 Participants
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
|---|---|---|
|
Progression Free Survival
|
6.3 Months
|
43.6 Months
Interval 30.7 to 48.1
|
Adverse Events
Cohort 1: Refractory/Relapsed After Prior Therapy
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Untreated With High-rRisk mMolecular Features
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1: Refractory/Relapsed After Prior Therapy
n=1 participants at risk
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
Cohort 2: Untreated With High-rRisk mMolecular Features
n=6 participants at risk
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
|---|---|---|
|
General disorders
Pain
|
100.0%
1/1 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
General disorders
Fever
|
0.00%
0/1 • Up to 8 months
|
33.3%
2/6 • Number of events 2 • Up to 8 months
|
Other adverse events
| Measure |
Cohort 1: Refractory/Relapsed After Prior Therapy
n=1 participants at risk
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
Cohort 2: Untreated With High-rRisk mMolecular Features
n=6 participants at risk
Participants receive Rituximab 375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22), then with start of each course. Lirilumab 3 mg/kg by vein given on Day 1 of each cycle. Rituximab given for the first 12 cycles and Lirilumab continues for up to 24 cycles. Each cycle is 4 weeks.
Lirilumab: 3 mg/kg by vein given on Day 1 of each 28 day cycle.
Rituximab: 375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
General disorders
Chills
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
General disorders
Cough
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
General disorders
Edema
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
Vascular disorders
Elevated Blood Pressure
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to 8 months
|
33.3%
2/6 • Number of events 2 • Up to 8 months
|
|
General disorders
Flu Like Symptoms
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
General disorders
Infusion Related Reaction
|
0.00%
0/1 • Up to 8 months
|
100.0%
6/6 • Number of events 6 • Up to 8 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
General disorders
Night Sweats
|
0.00%
0/1 • Up to 8 months
|
33.3%
2/6 • Number of events 2 • Up to 8 months
|
|
General disorders
Pain
|
0.00%
0/1 • Up to 8 months
|
33.3%
2/6 • Number of events 3 • Up to 8 months
|
|
General disorders
Rigors
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
Infections and infestations
Skin Infection
|
100.0%
1/1 • Number of events 1 • Up to 8 months
|
0.00%
0/6 • Up to 8 months
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to 8 months
|
16.7%
1/6 • Number of events 1 • Up to 8 months
|
Additional Information
Dr. Nitin Jain/Associate Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-745-6080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place