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Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03379051
Collaborator
James P. Wilmot Cancer Center (Other)
78
Enrollment
3
Locations
2
Arms
50.7
Actual Duration (Months)
26
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
Actual Study Start Date :
Mar 27, 2018
Actual Primary Completion Date :
May 26, 2022
Actual Study Completion Date :
Jun 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ublituximab + Umbralisib + Venetoclax

Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose

Drug: Venetoclax
BCL-2 Inhibitor
Other Names:
  • Venclexta

    • Drug: Umbralisib
    PI3K-Delta Inhibitor
    Other Names:
  • TGR-1202

    • Biological: Ublituximab
    Glycoengineered Anti-CD20 mAb
    Other Names:
  • TG-1101

    		•
    Experimental: Ublituximab + Umbralisib + Lenalidomide

    Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days

    Drug: Umbralisib
    PI3K-Delta Inhibitor
    Other Names:
  • TGR-1202

    • Biological: Ublituximab
    Glycoengineered Anti-CD20 mAb
    Other Names:
  • TG-1101

    • Drug: Lenalidomide
    Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties
    Other Names:
  • Revlimid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determine Acceptable Adverse Events That Are Related to Treatment [12 months]

    Secondary Outcome Measures

    1. Overall Response and Complete Remission Rate [12 months]

    2. Minimum Residual Disease (MRD) [12 months]

    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 Non-Hodgkin's Lymphoma

    • 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 21 days

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

    • Known histological transformation from CLL to an aggressive lymphoma (Richter's)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TG Therapeutics Investigational Trial Site Chicago Illinois United States 60611
    2 TG Therapeutics Investigational Trial Site Rochester New York United States 14642
    3 TG Therapeutics Investigational Trial Site Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • TG Therapeutics, Inc.
    • James P. Wilmot Cancer Center

    Investigators

    • Study Chair: Paul Barr, MD, Wilmot Cancer Institute - University of Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03379051
    Other Study ID Numbers:
    • U2-VEN-109
    First Posted:
    Dec 20, 2017
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia, Lymphocytic, Chronic, B-Cell
    Lenalidomide
    Venetoclax

    Study Results

    No Results Posted as of Aug 22, 2022