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

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04016805
Collaborator
(none)
84
Enrollment
3
Locations
3
Arms
51.9
Anticipated Duration (Months)
28
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 5, 2019
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: ublituximab + umbralisib + ibrutinib

ublituximab: 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

Drug: Ublituximab
recombinant chimeric anti-CD20 monoclonal antibody administered as an IV infusion
Other Names:
  • TG-1101
  • Drug: Umbralisib
    Phosphoinositide-3-kinase (PI3K) delta inhibitor Tablet form, to taken orally on a daily basis
    Other Names:
  • TGR-1202
  • Drug: Ibrutinib
    Bruton Tyrosine Kinase (BTK) inhibitor Tablet form, to taken orally on a daily basis
    Other Names:
  • Imbruvica
  • Experimental: ublituximab + umbralisib + venetoclax

    ublituximab: 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

    Drug: Ublituximab
    recombinant chimeric anti-CD20 monoclonal antibody administered as an IV infusion
    Other Names:
  • TG-1101
  • Drug: Umbralisib
    Phosphoinositide-3-kinase (PI3K) delta inhibitor Tablet form, to taken orally on a daily basis
    Other Names:
  • TGR-1202
  • Drug: Venetoclax
    BCL-2 inhibitor Tablet form, to be taken orally
    Other Names:
  • Venclexta
  • Experimental: ublituximab + umbralisib + acalabrutinib

    ublituximab: 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

    Drug: Ublituximab
    recombinant chimeric anti-CD20 monoclonal antibody administered as an IV infusion
    Other Names:
  • TG-1101
  • Drug: Umbralisib
    Phosphoinositide-3-kinase (PI3K) delta inhibitor Tablet form, to taken orally on a daily basis
    Other Names:
  • TGR-1202
  • Drug: Acalabrutinib Oral Capsule
    Kinase inhibitor, capsule form, to be taken orally
    Other Names:
  • Calquence
  • Outcome Measures

    Primary Outcome Measures

    1. Rate of minimal residual disease negativity [24 months]

      Assess the rate of undetectable minimal residual disease (U-MRD)

    Secondary Outcome Measures

    1. Overall Response Rate [24 months]

      Objective response in subjects treated on study

    2. Adverse Events that are Related to Treatment [12 months]

      Number of Participants With Treatment-Related Adverse Events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1TG Therapeutics Investigational Trial SiteBostonMassachusettsUnited States02114
    2TG Therapeutics Investigational Trial SiteHackensackNew JerseyUnited States07601
    3TG Therapeutics Investigational Trial SiteNew YorkNew YorkUnited States10065

    Sponsors and Collaborators

    • TG Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04016805
    Other Study ID Numbers:
    • UTX-TGR-208
    First Posted:
    Jul 11, 2019
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by TG Therapeutics, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 13, 2022