18 and older, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR)Primary· Up to 62 months
ORR: Percentage of participants with best overall response of partial response(PR) and complete response(CR). CR criteria: No evidence of new disease; Absolute lymphocyte count(ALC)\<4x10\^9/liter(L); Regression of all target nodal masses to ≤1.5 centimeters(cm) in longest diameter(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; Absolute neutrophil count(ANC)\>1.5x10\^9/L,platelets≥100x10\^9/L,hemoglobin (Hgb)≥110 gram per liter(g/L)
Group
Value
95% CI
Ublituximab + Ibrutinib
84.4
Ibrutinib
69.4
Complete Response (CR) RateSecondary· Up to 62 months
The CR rate was defined as the percentage of participants who achieved CR. CR criteria: No evidence of new disease; ALC \<4 x 10\^9/L; Regression of all target nodal masses to normal size ≤1.5 cm in the LD; Normal spleen and 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 \>1.5 x 10\^9/L, platelets ≥100 x 10\^9/L, Hgb ≥110 g/L.
Group
Value
95% CI
Ublituximab + Ibrutinib
18.8
Ibrutinib
4.8
Minimum Residual Disease (MRD) Negativity RateSecondary· Up to 62 months
MRD negativity rate was defined as the percentage of participants who were MRD negative post-baseline. 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.
Group
Value
95% CI
Ublituximab + Ibrutinib
45.3
32.8 – 58.3
Ibrutinib
9.7
3.6 – 19.9
Progression-Free Survival (PFS)Secondary· From the randomization until the first documentation of PD or death whichever occurs first or up to 62 months
PFS was defined as the time from the date of randomization until the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first. PD requires at least one of the following: New nodes \>1.5 cm in the 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 target lesions, ≥50% increase in the LD of an individual node or extra-nodal mass, splenic/hepatic enlargement of ≥50% from
Group
Value
95% CI
Ublituximab + Ibrutinib
NA
NA – NA
Ibrutinib
47.2
18.9 – NA
Duration of Response (DOR)Secondary· From the first dose of study drug until the first documentation of PD or death whichever occurs first or up to 62 months
DOR:Interval from first documentation of CR/PR to first documentation of PD or death from any cause.CR:ALC\<4x10\^9/L;Regression to normal of target nodal masses,nodal non-target disease,and no detectable non-nodal,non-target disease;Normal spleen,liver size;Morphologically negative bone marrow,No lymphoid nodules;ANC\>1.5x10\^9/L,Platelets≥100x10\^9/L,Hgb≥110 g/L.PR:Response in 2 or more:ALC\<4x10\^9/L,\>=50% drop from baseline in ALC or SPD of target nodal lesions,Hepatosplenomegaly,\>=50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules;Response in 1 or more:ANC\>1.5x10\^9
Group
Value
95% CI
Ublituximab + Ibrutinib
NA
NA – NA
Ibrutinib
39.1
16.7 – NA
Time to Response (TTR)Secondary· From the randomization up to 62 months
TTR was defined as the interval from the randomization to the first documentation of CR or PR. CR criteria: No evidence of new disease; ALC \<4 x 10\^9/L; Regression of all target nodal masses to normal size ≤1.5 cm in the LD; Normal spleen and 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 \>1.5 x 10\^9/L, platelets ≥100 x 10\^9/L, Hgb ≥110 g/L. PR criteria: No evidence of new disease; Response in 2 of following when abnormal at baseline: ALC\<4
Group
Value
95% CI
Ublituximab + Ibrutinib
2.0
2.0 – 2.1
Ibrutinib
3.9
2.2 – 8.3
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)Secondary· From the first dose up to 30 days after the last dose of study drug (up to 57.3 months)
An adverse event (AE) is 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 subseque
Group
Value
95% CI
Ublituximab + Ibrutinib
100
Ibrutinib
100
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events: From the first dose up to 30 days after the last dose of study drug (up to 57.3 months); All-Cause Mortality: From the first dose up to end of study (up to 62 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ublituximab + Ibrutinib
Serious: 38/59 (64%)
Deaths: 5/59
Ibrutinib
Serious: 31/58 (53%)
Deaths: 9/58
Serious adverse events (87 terms)
Reaction
System
Ublituximab + Ibrutinib
Ibrutinib
Pneumonia
Infections and infestations
—
—
Atrial fibrillation
Cardiac disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Sepsis
Infections and infestations
—
—
Cardiac failure
Cardiac disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Dysphagia
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Cellulitis
Infections and infestations
—
—
Hypokalaemia
Metabolism and nutrition disorders
—
—
Hyponatraemia
Metabolism and nutrition disorders
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Syncope
Nervous system disorders
—
—
Mental status changes
Psychiatric disorders
—
—
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
Angina pectoris
Cardiac disorders
—
—
Atrial flutter
Cardiac disorders
—
—
Cardiac arrest
Cardiac disorders
—
—
Coronary artery disease
Cardiac disorders
—
—
Pericarditis
Cardiac disorders
—
—
Acute myocardial infarction
Cardiac disorders
—
—
Cardiac failure congestive
Cardiac disorders
—
—
Other adverse events (128 terms — click to expand)
This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR \[complete response\] + PR \[partial response\]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
· Phase 2, PHASE3
· not yet recruiting
NCT06864936 — Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
· NA
· not yet recruiting
NCT07503873 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection
· Phase 2
· not yet recruiting
NCT07225361 — Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
· Phase 4
· recruiting
NCT06629428 — Effects of Ublituximab on Motor Functions in Multiple Sclerosis
· EARLY_PHASE1
· recruiting
Other recruiting trials for Chronic Lymphocytic Leukemia
Currently open trials in the same condition.
NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa
· Phase 1
· recruiting
NCT06863402 — Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype
· Phase 2
· recruiting
NCT07218510 — Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Smal
· Phase 2
· recruiting
NCT07288515 — Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus
· recruiting
NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL
· Phase 2
· recruiting
Other TG Therapeutics, Inc. trials
Trials by the same sponsor.
NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
· Phase 2, PHASE3
· not yet recruiting
NCT07503873 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection
· Phase 2
· not yet recruiting
NCT07211633 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ub
· Phase 3
· recruiting
NCT06680037 — A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
· Phase 1
· recruiting
NCT06433752 — A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Mult
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by TG Therapeutics, Inc.
Last refreshed: 20 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02301156.