A Phase 1/2 Study of Umbralisib, Ublituximab and Venetoclax in Patients with R/R CLL

[Jm954]

Only small numbers of patients (21) but looks promising with potential for patients for cardiac issues.

Umbralisib (Umbra) is a novel, highly-specific PI3Kδ inhibitor and ublituximab (Ubli) is a chimeric monoclonal antibody targeting a unique epitope on CD20 and glycoengineered to enhance antibody dependent cellular toxicity. Combining these agents with the BCL2 inhibitor venetoclax (Ven) may prevent drug resistance (Choudhary, Cell Death Dis 2015), avoid tumor lysis syndrome (TLS) and achieve undetectable minimal residual disease (MRD). This phase 1/2 trial evaluates the safety and efficacy of Umbra + Ubli + Ven for 12 cycles followed by MRD evaluation in relapsed or refractory CLL patients (pts).

The phase 2 dose of Umbra + Ubli + Ven and demonstrated good tolerability in pts with relapsed or refractory CLL. Preliminary results suggest that this chemotherapy-free regimen can provide undetectable MRD after only 12 cycles, representing an effective treatment plan for this population. Ongoing enrollment is focused on pts who have relapsed after BTK inhibitors and a multi-center trial is planned to further develop the triplet regimen.

More here: ash.confex.com/ash/2019/web...

All these studies give us hope for the future

Jackie

[avzuclav]

This appears to be a recruiting trial at several locations in the USA.

clinicaltrials.gov/ct2/show...

[HopeME]

Wow! Excellent results. Someone is going to figure out how to cure this disease in the next 5-10 years. It is clearly going to be V + something else. The researchers need to figure out what is are the best combinations, for how long, when to stop, etc. Time is the missing ingredient for the researchers. They need time to watch their clinical trial cohorts and prove their hypothesizes. If my kids get this Cancer in years to come it won’t be a devastating diagnosis.