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Clinical Trial 20052

Cancer Type: Malignant Hematology
Interventions:GDC-0199 (Venetoclax); Ublituximab (); Umbralisib (); Venetoclax ()

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Javier Pinilla-Ibarz

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

ULTRA-V: Phase 2 Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) in Subjects with Chronic Lymphocytic Leukemia (CLL)

Summary

This is a Phase II study designed to investigate the efficacy and safety of ublituximab and umbralisib combined with venetoclax in subjects with CLL.

Objective

PRIMARY OBJECTIVES To determine the Complete Response (CR) rate of the combination of ublituximab, umbralisib, and venetoclax To determine the Overall Response Rate (ORR) of the combination of ublituximab, umbralisib, and venetoclax SECONDARY OBJECTIVES To determine the rate of MRD negativity To determine Time to Response (TTR), Duration of response (DOR), and Progression-Free survival (PFS) To characterize the safety of the combination regimen

Inclusion Criteria

  • Chronic Lymphocytic Leukemia (CLL) that warrants treatment
  • 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.
  • Autologous hematologic stem cell transplant within 6 months of study entry. Prior. Allogeneic hematologic stem cell transplant is excluded.
  • Active Hepatitis B or Hepatitis C.