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

Status: Active

Description

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

Eligibility Criteria

Inclusion Criteria

  • Subjects with Chronic Lymphocytic Leukemia (CLL) who have been on treatment for at least 6 months
  • Minimal Residual Disease positive at screening
  • Adequate organ system function as specified in the protocol
  • Ability to follow protocol procedures.

Exclusion Criteria

  • Subjects receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1.
  • Subjects with a known histological transformation
  • Active Hepatitis B or Hepatitis C.

Locations & Contacts

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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 subjects with CLL, who fail to achieve MRD negativity, after a minimum 6-month treatment with ibrutinib or venetoclax.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
TG Therapeutics Inc

Trial IDs

Primary ID UTX-TGR-208
Secondary IDs NCI-2019-06447
Clinicaltrials.gov ID NCT04016805