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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Chronic Lymphocytic Leukemia
CLL Progression
CLL/SLL
Disease Progression
Leukemia, Lymphocytic, Chronic, B-Cell

Clinical Trial Details

NCT number	NCT04149821
Study type	Interventional
Source	Weill Medical College of Cornell University
Contact
Status	Terminated
Phase	Phase 2
Start date	February 10, 2021
Completion date	June 9, 2022

View Details

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