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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)

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: NCT03801525
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
ULTRA-V: 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)

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Ublituximab Drug: Umbralisib Drug: Venetoclax Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 12 months ]
    Objective response in subjects treated with ublituximab + umbralisib + venetoclax


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801525


Contacts
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Contact: TG Therapeutics Clinical Support Team 212-554-4484 clinicalsupport@tgtxinc.com

Locations
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United States, Alabama
TG Therapeutics Investigational Trial Site Recruiting
Birmingham, Alabama, United States, 35294
TG Therapeutics Investigational Trial Site Recruiting
Huntsville, Alabama, United States, 35805
United States, California
TG Therapeutics Investigational Trial Site Recruiting
Duarte, California, United States, 91010
TG Therapeutics Investigational Trial Site Recruiting
La Jolla, California, United States, 92093
United States, Colorado
TG Therapeutics Investigational Trial Site Recruiting
Aurora, Colorado, United States, 80012
United States, Florida
TG Therapeutics Investigational Trial Site Recruiting
Jacksonville, Florida, United States, 32224
TG Therapeutics Investigational Trial Site Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
TG Therapeutics Investigational Trial Site Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
TG Therapeutics Investigational Trial Site Recruiting
Niles, Illinois, United States, 60714
TG Therapeutics Investigational Site Recruiting
Peoria, Illinois, United States, 61615
United States, Kansas
TG Therapeutics Investigational Trial Site Recruiting
Westwood, Kansas, United States, 66210
United States, Kentucky
TG Therapeutics Investigational Site Recruiting
Louisville, Kentucky, United States, 40207
United States, Maryland
TG Therapeutics Investigational Trial Site Recruiting
Columbia, Maryland, United States, 21044
United States, Minnesota
TG Therapeutics Investigational Trial Site Recruiting
Rochester, Minnesota, United States, 55905
United States, Nebraska
TG Therapeutics Investigational Trial Site Recruiting
Omaha, Nebraska, United States, 68198
United States, New York
TG Therapeutics Investigational Trial Site Recruiting
New York, New York, United States, 10065
United States, North Carolina
TG Therapeutics Investigational Trial Site Recruiting
Charlotte, North Carolina, United States, 28204
United States, Ohio
TG Therapeutics Investigational Trial Site Recruiting
Columbus, Ohio, United States, 43210
United States, Oregon
TG Therapeutics Investigational Trial Site Recruiting
Eugene, Oregon, United States, 97401
United States, Pennsylvania
TG Therapeutics Investigational Trial Site Recruiting
Philadelphia, Pennsylvania, United States, 19106
United States, South Carolina
TG Therapeutics Investigational Trial Site Recruiting
Greenville, South Carolina, United States, 29616
United States, Tennessee
TG Therapeutics Investigational Trial Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
TG Therapeutics Investigational Trial Site Recruiting
Austin, Texas, United States, 78705
TG Therapeutics Investigational Trial Site Recruiting
San Antonio, Texas, United States, 78229
TG Therapeutics Investigational Trial Site Recruiting
Tyler, Texas, United States, 75702
United States, Utah
TG Therapeutics Investigational Trial Site Recruiting
Ogden, Utah, United States, 84405
United States, Virginia
TG Therapeutics Investigational Trial Site Recruiting
Blacksburg, Virginia, United States, 24060
TG Therapeutics Investigational Trial Site Recruiting
Gainesville, Virginia, United States, 20155
United States, Washington
TG Therapeutics Investigational Trial Site Recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
TG Therapeutics, Inc.
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03801525    
Other Study ID Numbers: U2-VEN-207
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data for this study will be shared after the last patient visit has been completed.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TG Therapeutics, Inc.:
CLL
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Venetoclax
Antineoplastic Agents