18 and older, any sex, with Chronic Lymphocytic Leukemia or CLL Progression. 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.
Efficacy of Umbralisib in Combination With Ublituximab (U2) as Measured by Overall Response Rate (ORR) in Patients With CLL Who Have Progressed on a BTKi or BCL-2 InhibitorPrimary· 11 months
Number of subjects who achieve a partial or complete response
Group
Value
95% CI
Cohort B Post BCL-2 Therapy
0
Safety of Umbralisib in Combination With Ublituximab (U2) as Measured by the Percentage of Subjects Who Experience 1 or More Adverse EventsSecondary· 1 year and 4 months
Rate of subjects who experience 1 or more adverse events
Group
Value
95% CI
Cohort B Post BCL-2 Therapy
1
Complete Remission Rate as Measured by the Number of Subjects Who Achieve Complete Response as Their Best ResponseSecondary· 1 year and 4 months
Number of subjects who achieve complete response on study
Group
Value
95% CI
Cohort B Post BCL-2 Therapy
0
Duration of ResponseSecondary· 1 year and 4 months
Median interval of time between subjects' first objective response to the first sign of disease progression
Group
Value
95% CI
Cohort B Post BCL-2 Therapy
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year and 3 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study evaluates the efficacy and safety of umbralisib and ublituximab (U2) as salvage therapy in patients with chronic lymphocytic leukemia (CLL) who have progressed either on a BTK inhibitor (BTKi) or BCL-2 inhibitor. The study will evaluate this combination in two parallel cohorts and subjects will be assigned based on which class of novel agent-containing regimen was used prior. Cohort A will consist of patients who progress after BTKi containing regimens and Cohort B will consist of patients who progress after a BCL-2 containing regimen. Subjects who progress on a regimen containing both a BTKi and a BCL-2 inhibitor, will be enrolled in cohort B. Each cohort will be evaluated independently of each other.
Publications & conference data
6 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
NCT04624633 — Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL
· Phase 2
· active not recruiting
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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 Weill Medical College of Cornell University
Last refreshed: 15 June 2023
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/NCT04149821.