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Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib or Venetoclax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04016805
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date January 7, 2020
Actual Study Start Date  ICMJE August 5, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
Rate of minimal residual disease negativity [ Time Frame: 24 months ]
Assess the rate of undetectable minimal residual disease (U-MRD)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04016805 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
  • Overall Response Rate [ Time Frame: 24 months ]
    Objective response in subjects treated on study
  • Adverse Events that are Related to Treatment [ Time Frame: 12 months ]
    Number of Participants With Treatment-Related Adverse Events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib or Venetoclax
Official Title  ICMJE 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 or Venetoclax
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 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 or venetoclax.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: Ublituximab
    • recombinant chimeric anti-CD20 monoclonal antibody
    • administered as an IV infusion
    Other Name: TG-1101
  • Drug: Umbralisib
    • Phosphoinositide-3-kinase (PI3K) delta inhibitor
    • Tablet form, to taken orally on a daily basis
    Other Name: TGR-1202
  • Drug: Ibrutinib
    • Bruton Tyrosine Kinase (BTK) inhibitor
    • Tablet form, to taken orally on a daily basis
    Other Name: Imbruvica
  • Drug: Venetoclax
    • BCL-2 inhibitor
    • Tablet form, to be taken orally
    Other Name: Venclexta
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Ublituximab
    • Drug: Umbralisib
    • Drug: Ibrutinib
  • 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

    Interventions:
    • Drug: Ublituximab
    • Drug: Umbralisib
    • Drug: Venetoclax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2019)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: TG Therapeutics Clinical Support Team 212-554-4484 clinicalsupport@tgtxinc.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04016805
Other Study ID Numbers  ICMJE UTX-TGR-208
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party TG Therapeutics, Inc.
Study Sponsor  ICMJE TG Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TG Therapeutics, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP