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Clinical Trial 20052

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03801525

Phase: Phase II
Prinicipal Investigator:

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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

Treatments

Therapies

Medications

GDC-0199 (Venetoclax); Ublituximab (); Umbralisib (); Venetoclax ()

Inclusion Criteria

  • B-cell Chronic Lymphocytic Leukemia (CLL) that warrants treatment consistent with iwCLL 2018 criteria for initiation of therapy with diagnosis established according to iwCLL 2018 criteria and documented within medical records
  • Adequate organ system function independent of growth factor or transfusion support 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.
  • Known histological transformation from CLL to an aggressive lymphoma such as Richter’s Transformation. Prolymphocytic leukemia is also excluded.
  • History of CLL with CNS involvement.
  • Prior exposure to any PI3K inhibitor (e.g. idelalisib, duvelisib, umbralisib (TGR-1202), etc.) or venetoclax (ABT-199, GDC-0199).
  • Inability to swallow and retain oral medications.
  • No known barriers to commercially available venetoclax.
  • Evidence of ongoing systemic bacterial, fungal or viral infection, except localized fungal infections of skin or nails.
  • Live virus vaccines within 4 weeks prior to or during study therapy.
  • History of anaphylaxis (excluding infusion related reactions) in association with previous anti- CD20 administration.
  • Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: (a) Symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV) (b) Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of randomization. (c) Concomitant use of medication known to cause QT prolongation or torsades de pointes should be used with caution and at investigator discretion. (d) Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac/vascular stenting within 6 months of randomization.
  • Requirement for use of strong or moderate CYP3A inhibitors, strong or moderate CYP3A inducers, P-gp inhibitors, or narrow therapeutic index P-gp substrates (See Appendix D).
  • Malignancy within 3 years of study enrollment except for adequately treated basal, squamous cell carcinoma or non-melanomatous skin cancer, carcinoma in situ of the cervix, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months, localized prostate cancer and PSA > Women who are pregnant or lactating.

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