Trial Outcomes & Findings for Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia (NCT NCT02612311)

Last Updated: 2024-12-13

Results Overview

PFS was defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. PD was appearance of new nodes \>1.5 centimetres (cm) in the longest diameter (LD) and \>1.0 in longest perpendicular diameter (LPD), new or recurrent hepatomegaly or splenomegaly, new or reappearance of an unequivocal extra-nodal lesion, ≥50% increase from the nadir in the sum of products of diameters (SPD) of target lesions, ≥50% increase in the LD of an individual node or extra-nodal mass, splenic/hepatic enlargement of ≥50% from nadir, unequivocal increase in the size of non-target disease, transformation to a more aggressive histology, decrease in platelet count or Hgb, \>50% decrease from the highest on-study platelet count, \>20 grams per Liter (g/L) decrease from the highest on-study hemoglobin (Hgb).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

603 participants

Primary outcome timeframe

From enrolment to the earlier of the first documentation of definitive disease progression (PD) or death (Up to 87 months)

Results posted on

2024-12-13

Participant Flow

Participants took part in the study at multiple investigative sites in the United States, Israel, Italy, Poland, Russian Federation, Spain and the United Kingdom from 19 November 2015 to 22 February 2023.

Participant milestones

Participant milestones
Measure	Experimental: Arm A: Ublituximab + Umbralisib Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Active Comparator: Arm B: Obinutuzumab + Chlorambucil Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm C: Ublituximab Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm D: Umbralisib Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.
Overall Study STARTED	210	211	91	91
Overall Study Safety Population	206	200	91	86
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	210	211	91	91

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Arm A: Ublituximab + Umbralisib Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Active Comparator: Arm B: Obinutuzumab + Chlorambucil Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm C: Ublituximab Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm D: Umbralisib Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.
Overall Study Adverse Event	16	12	7	13
Overall Study Death	29	10	11	11
Overall Study Initiation of Non-protocol Intervention	5	3	0	0
Overall Study Investigator's Decision	11	15	6	6
Overall Study Lack of Efficacy	0	0	1	1
Overall Study Lost to Follow-up	2	2	1	2
Overall Study Progressive Disease Confirmed by Central Radiology	75	113	38	43
Overall Study Site Terminated by Sponsor	29	12	13	5
Overall Study Withdrawal by Subject of Consent or to Discontinue Treatment	29	24	6	5
Overall Study Reason Not Specified	3	7	4	5
Overall Study Unknown/Missing	10	13	4	0
Overall Study Non-Compliance with Study	1	0	0	0

Baseline Characteristics

Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: Arm A: Ublituximab + Umbralisib n=210 Participants Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Active Comparator: Arm B: Obinutuzumab + Chlorambucil n=211 Participants Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm C: Ublituximab n=91 Participants Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm D: Umbralisib n=91 Participants Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.	Total n=603 Participants Total of all reporting groups
Age, Continuous	66.2 years n=5 Participants	67.1 years n=7 Participants	67.6 years n=5 Participants	66.3 years n=4 Participants	66.8 years n=21 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	67 Participants n=7 Participants	23 Participants n=5 Participants	30 Participants n=4 Participants	195 Participants n=21 Participants
Sex: Female, Male Male	135 Participants n=5 Participants	144 Participants n=7 Participants	68 Participants n=5 Participants	61 Participants n=4 Participants	408 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	193 Participants n=5 Participants	194 Participants n=7 Participants	86 Participants n=5 Participants	83 Participants n=4 Participants	556 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	12 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	34 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	25 Participants n=21 Participants
Race/Ethnicity, Customized White	189 Participants n=5 Participants	195 Participants n=7 Participants	83 Participants n=5 Participants	82 Participants n=4 Participants	549 Participants n=21 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Not Reported	8 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	18 Participants n=21 Participants

PRIMARY outcome

Timeframe: From enrolment to the earlier of the first documentation of definitive disease progression (PD) or death (Up to 87 months)

Population: The ITT population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202).

Outcome measures

Outcome measures
Measure	Experimental: Arm A: Ublituximab + Umbralisib n=210 Participants Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Active Comparator: Arm B: Obinutuzumab + Chlorambucil n=211 Participants Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm C: Ublituximab n=91 Participants Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm D: Umbralisib n=91 Participants Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.
Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria	33.2 Months Interval 27.7 to 39.6	17.5 Months Interval 16.6 to 22.6	32.9 Months Interval 19.1 to 45.0	22.4 Months Interval 17.2 to 34.7

SECONDARY outcome

Timeframe: Up to 87 months

Population: The ITT population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202). Percentages are rounded off to the nearest decimal point.

ORR=percent of participants who achieve complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR) or nodular partial response (nPR).CR: No evidence of new disease; Absolute lymphocyte count(ALC)\<4x10\^9/liter(L);Regression of all target nodal masses to ≤1.5cm in LD;Normal spleen,liver size;Regression to normal of all nodal non-target disease and disappearance of all detectable;Non-nodal,non-target disease;Morphologically negative bone marrow;No lymphoid nodules;ANC \>1.5x10\^9/L,platelets≥100x10\^9/L,Hgb≥110 g/L.PR:No evidence of new disease; Response in 2 of following if abnormal at baseline: ALC\<4x10\^9/L or ≥50% decrease from baseline in sum of products of target nodal lesions;splenomegaly; hepatomegaly;≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules;response in any 1: ANC\>1.5x10\^9/L, platelets\>100x10\^9/L,Hgb\>110g/L or ≥50% increase over baseline in any of these.CRi:for CR except with ANC\<1000/µL and/or platelets\<100.

Outcome measures

Outcome measures
Measure	Experimental: Arm A: Ublituximab + Umbralisib n=210 Participants Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Active Comparator: Arm B: Obinutuzumab + Chlorambucil n=211 Participants Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm C: Ublituximab n=91 Participants Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm D: Umbralisib n=91 Participants Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.
Overall Response Rate (ORR) Per iwCLL Criteria	83.3 percentage of participants	68.7 percentage of participants	42.9 percentage of participants	61.5 percentage of participants

SECONDARY outcome

Timeframe: Up to 87 months

The CR rate is defined as the percentage of participants with a best overall response of complete response (CR) or complete response with incomplete marrow recovery (CRi). CR: No evidence of new disease; Absolute lymphocyte count(ALC)\<4x10\^9/L; Regression of all target nodal masses to ≤1.5 cm in LD; Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; ANC\>1.5x10\^9/L,platelets≥100x10\^9/L,hemoglobin (Hgb)≥110 g/L. CRi was as for CR except with ANC \<1000/µL and/or platelets \<100,000/µL.

Outcome measures

Outcome measures
Measure	Experimental: Arm A: Ublituximab + Umbralisib n=210 Participants Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Active Comparator: Arm B: Obinutuzumab + Chlorambucil n=211 Participants Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm C: Ublituximab n=91 Participants Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm D: Umbralisib n=91 Participants Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.
Complete Response (CR) Rate	5.7 percentage of participants	1.4 percentage of participants	3.3 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From Cycle 6 until Cycle 15 (cycle length=28 days) up to approximately 81.5 months

MRD negativity rate is defined as the percentage of participants who are MRD negative. If a participant was determined to be MRD negative by peripheral blood, a bone marrow aspirate was obtained to assess MRD in the bone marrow.

Outcome measures

Outcome measures
Measure	Experimental: Arm A: Ublituximab + Umbralisib n=210 Participants Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Active Comparator: Arm B: Obinutuzumab + Chlorambucil n=211 Participants Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm C: Ublituximab n=91 Participants Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm D: Umbralisib n=91 Participants Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.
Minimal Residual Disease (MRD) Negativity Rate	29.0 percentage of participants	34.6 percentage of participants	36.3 percentage of participants	5.5 percentage of participants

SECONDARY outcome

Timeframe: From first documentation of response to study treatment till disease progression/death (up to approximately 87 months)

Population: The ITT population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202). Overall Number of Participants Analyzed is the number of participants with data available for analysis.

DOR is defined as the interval from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of definitive disease progression or death from any cause.

Outcome measures

Outcome measures
Measure	Experimental: Arm A: Ublituximab + Umbralisib n=175 Participants Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Active Comparator: Arm B: Obinutuzumab + Chlorambucil n=145 Participants Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm C: Ublituximab n=39 Participants Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm D: Umbralisib n=56 Participants Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.
Duration of Response (DOR)	32.9 months Interval 27.8 to 39.4	21.9 months Interval 14.6 to 26.6	47.5 months Interval 40.3 to 57.8	29.3 months Interval 17.1 to 36.5

SECONDARY outcome

Timeframe: From first dose of study treatment up to end of study (up to approximately 87 months)

Population: The safety population included all randomized participants who had received at least one dose of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related.

Outcome measures

Outcome measures
Measure	Experimental: Arm A: Ublituximab + Umbralisib n=206 Participants Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Active Comparator: Arm B: Obinutuzumab + Chlorambucil n=200 Participants Participants received obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 5 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with chlorambucil 0.5 milligrams per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm C: Ublituximab n=91 Participants Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Experimental: Arm D: Umbralisib n=86 Participants Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)	205 Participants	195 Participants	88 Participants	86 Participants

Adverse Events

Experimental: Arm A: Ublituximab + Umbralisib

Serious events: 118 serious events

Other events: 205 other events

Deaths: 82 deaths

Active Comparator: Arm B: Obinutuzumab + Chlorambucil

Serious events: 47 serious events

Other events: 189 other events

Deaths: 40 deaths

Experimental: Arm C: Ublituximab

Serious events: 33 serious events

Other events: 84 other events

Deaths: 25 deaths

Experimental: Arm D: Umbralisib

Serious events: 34 serious events

Other events: 84 other events

Deaths: 29 deaths

Serious adverse events

Other adverse events

Additional Information

TG Therapeutics Clinical Support Team

TG Therapeutics

Phone: 1-877-575-8489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place