NCT04016805

Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

A Phase 2 Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: TG Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.

Detailed description

This is a Phase 2 open label, two treatment cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with CLL, who fail to achieve MRD negativity, after a minimum 6-month treatment with ibrutinib, alacabrutinib or venetoclax.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Ublituximab	* recombinant chimeric anti-CD20 monoclonal antibody * administered as an IV infusion
DRUG	Umbralisib	* Phosphoinositide-3-kinase (PI3K) delta inhibitor * Tablet form, to taken orally on a daily basis
DRUG	Ibrutinib	* Bruton Tyrosine Kinase (BTK) inhibitor * Tablet form, to taken orally on a daily basis
DRUG	Venetoclax	* BCL-2 inhibitor * Tablet form, to be taken orally
DRUG	Acalabrutinib Oral Capsule	Kinase inhibitor, capsule form, to be taken orally

Timeline

• Start date: 2019-08-05
• Primary completion: 2022-05-22
• Completion: 2022-05-22
• First posted: 2019-07-11
• Last updated: 2023-07-24
• Results posted: 2023-07-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study