Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02535286
Collaborator
Memorial Sloan Kettering Cancer Center (Other)
27
Enrollment
4
Locations
1
Arm
73.6
Actual Duration (Months)
6.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL
Actual Study Start Date :
Sep 18, 2015
Actual Primary Completion Date :
Nov 4, 2021
Actual Study Completion Date :
Nov 4, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: TG-1501 + Ublituximab + Umbralisib

Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals

Drug: Umbralisib
A once daily oral agent
Other Names:
  • TGR-1202
  • Biological: ublituximab
    IV anti-CD20 monoclonal antibody
    Other Names:
  • TG-1101
  • Biological: TG-1501
    IV immunotherapy for cancer

    Outcome Measures

    Primary Outcome Measures

    1. Determine Acceptable Adverse Events That Are Related to Treatment [6 months of therapy]

      To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

    Secondary Outcome Measures

    1. Overall Response Rate [Up to 1 year]

      The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation

    • Refractory to or relapsed after at least 1 prior treatment regimen

    • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

    Exclusion Criteria:
    • Any major surgery, chemotherapy or immunotherapy within the last 14 days

    • Known hepatitis B virus, hepatitis C virus or HIV infection

    • Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1TG Therapeutics Investigational Trial SiteNew YorkNew YorkUnited States10065
    2TG Therapeutics Investigational Trial SiteDurhamNorth CarolinaUnited States27710
    3TG Therapeutics Investigational Trial SitePhiladelphiaPennsylvaniaUnited States19104
    4TG Therapeutics Investigational Trial SiteSeattleWashingtonUnited States98109

    Sponsors and Collaborators

    • TG Therapeutics, Inc.
    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Study Chair: Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02535286
    Other Study ID Numbers:
    • TG-UPCC-108
    First Posted:
    Aug 28, 2015
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021

    Study Results

    No Results Posted as of Jan 11, 2022