NCT04149821

Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy

Phase II Study of Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a single-center, two cohort Phase 2 clinical trial investigating the effectiveness of umbralisib and ublituximab in patients with progressive CLL. Cohort A will consist of patients who who have progressed after receiving either a BTK inhibitor (BTKi) or BCL-2 inhibitor.

Conditions

• Chronic Lymphocytic Leukemia
• CLL Progression
• CLL/SLL

Interventions

Type	Name	Description
DRUG	Umbralisib	* Lead-in cycle of 28 days (Cycle -1) of umbralisib monotherapy, 800mg oral daily * Continued 800mg oral daily dosing in all subsequent cycles (combination therapy cycles 1-6, then continued monotherapy cycle 7 and beyond)
DRUG	Ublituximab	-Co-administered on days 1 and 2 (dose split over days 1 and 2), 8, 15 of cycle 1 then on day 1 for subsequent cycles 2-6

Timeline

• Start date: 2021-02-10
• Primary completion: 2022-01-21
• Completion: 2022-06-09
• First posted: 2019-11-04
• Last updated: 2023-06-15
• Results posted: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study