Clinical Trials /

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

NCT04016805

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, alacabrutinib or venetoclax.

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04016805

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: UTX-TGR-208
  • NCT ID: NCT04016805

Conditions

  • Chronic Lymphocytic Leukemia

Interventions

DrugSynonymsArms
UblituximabTG-1101ublituximab + umbralisib + acalabrutinib
UmbralisibTGR-1202ublituximab + umbralisib + acalabrutinib
IbrutinibImbruvicaublituximab + umbralisib + ibrutinib
VenetoclaxVenclextaublituximab + umbralisib + venetoclax
Acalabrutinib Oral CapsuleCalquenceublituximab + umbralisib + acalabrutinib

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
ublituximab + umbralisib + ibrutinibExperimentalublituximab: 900 mg; to be administered once every cycle through cycle 6, then every 3 cycles thereafter umbralisib: 800 mg; to be administered daily ibrutinib: dose tolerated by subject; to be administered daily
  • Ublituximab
  • Umbralisib
  • Ibrutinib
ublituximab + umbralisib + venetoclaxExperimentalublituximab: 900 mg; to be administered once every cycle through cycle 6, then every 3 cycles thereafter umbralisib: 800 mg; to be administered daily venetoclax: dose tolerated by subject; to be administered daily
  • Ublituximab
  • Umbralisib
  • Venetoclax
ublituximab + umbralisib + acalabrutinibExperimentalublituximab: 900 mg; to be administered once every cycle through cycle 6, then every 3 cycles thereafter umbralisib: 800 mg; to be administered daily acalabrutinib: previously tolerated dose; to be administered every 12 hours
  • Ublituximab
  • Umbralisib
  • Acalabrutinib Oral Capsule

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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Rate of minimal residual disease negativity
Time Frame:24 months
Safety Issue:
Description:Assess the rate of undetectable minimal residual disease (U-MRD)

Secondary Outcome Measures

Measure:Overall Response Rate
Time Frame:24 months
Safety Issue:
Description:Objective response in subjects treated on study
Measure:Adverse Events that are Related to Treatment
Time Frame:12 months
Safety Issue:
Description:Number of Participants With Treatment-Related Adverse Events

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:TG Therapeutics, Inc.

Trial Keywords

  • umbralisib
  • ublituximab
  • venetoclax
  • ibrutinib
  • CLL
  • acalabrutinib

Last Updated

August 23, 2021