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.
Progression-free SurvivalPrimary· From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)
PFS was defined as the interval from Day 1 to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. Participants who had no event (progression or death) were censored at the day of their last adequate disease assessment.
Group
Value
95% CI
Umbralisib
19.7
12.9 – 24.8
Overall Response Rate (ORR)Secondary· Up to 61.7 months
ORR=percent of participants who achieve complete response (CR), or partial response (PR).
Group
Value
95% CI
Umbralisib
34
Time to Treatment Failure (TTF)Secondary· From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months)
TTF is defined as a composite endpoint measuring time from Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. Estimates of median TTF was made using Kaplan-Meier methods.
Group
Value
95% CI
Umbralisib
13.6
9.4 – 19.0
Duration of Response (DOR)Secondary· From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months)
DOR defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. Estimates of median DOR was made using Kaplan-Meier methods.
Group
Value
95% CI
Umbralisib
19.4
8.4 – NA
Number of Participants With Treatment-Emergent Adverse Events (TEAE's) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)Secondary· From first dose of study treatment up to end of study (up to 61.7 months)
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 3
Group
Value
95% CI
Umbralisib
51
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study treatment up to end of study (up to approximately 61.7 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05152459 — Tazemetostat in Combination With Umbralisib and Ublituximab for the Treatment Relapsed or Refractory Follicular Lymphoma
· Phase 1, PHASE2
· withdrawn
NCT04635683 — Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or M
· Phase 1
· withdrawn
NCT04692155 — Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously U
· Phase 1, PHASE2
· terminated
NCT04783415 — Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma
· Phase 2
· active not recruiting
NCT04149821 — Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy
· Phase 2
· terminated
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Trials by the same sponsor.
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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: 3 July 2024
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/NCT02742090.