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Study to Assess the Efficacy and Safety of Ublituximab Plus Umbralisib in Combination With Venetoclax in Subjects With CLL (ULTRA-V)

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ClinicalTrials.gov Identifier: NCT03801525
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 11, 2019
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE May 16, 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
Overall Response Rate [ Time Frame: Up to 12 months ]
Objective response in subjects treated with ublituximab + umbralisib + venetoclax
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03801525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
Adverse Events That Are Related to Treatment [ Time Frame: 6 months of therapy ]
Number of Participants With Treatment-Related Adverse Event and any potential abnormal laboratory results
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 Plus Umbralisib in Combination With Venetoclax in Subjects With CLL
Official Title  ICMJE Phase 2 Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax (U2-V) in Subjects With Chronic Lymphocytic Leukemia (CLL)
Brief Summary Phase II study designed to investigate the efficacy and safety of ublituximab and umbralisib combined with venetoclax in subjects with CLL.
Detailed Description This is an open-label, multicenter, Phase II study designed to investigate the efficacy and safety of ublituximab and umbralisib combined with venetoclax in subjects with Chronic Lymphocytic Leukemia.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group 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
    • to be administered on Cycle 1 Days 1, 2, 8, and 15; then Day 1 of Cycles 2-6
    Other Name: TG-1101
  • Drug: Umbralisib
    • PI3K delta inhibitor
    • Tablet form, to taken orally on a daily basis
    Other Name: TGR-1202
  • Drug: Venetoclax
    • BCL-2 inhibitor
    • Tablet form, to be taken orally
    • Will begin treatment at Cycle 4 (follow dose ramp up schedule); then continue at 400 mg from cycles 5-24.
    Other Name: Venclexta
Study Arms  ICMJE Experimental: ublituximab + umbralisib + venetoclax

ublituximab: 900 mg; to be administered through cycle 6 only

umbralisib: 800 mg; to be administered daily

venetoclax: to begin at cycle 4 (dose ramp-up schedule) and continue through cycle 24

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: January 9, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic Lymphocytic Leukemia (CLL) that warrants treatment
  • 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.
  • Autologous hematologic stem cell transplant within 6 months of study entry. Prior. Allogeneic hematologic stem cell transplant is excluded.
  • 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 NCT03801525
Other Study ID Numbers  ICMJE U2-VEN-207
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
Plan Description: Data for this study will be shared after the last patient visit has been completed.
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 October 2019

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