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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.

Study Description
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Brief Summary:
Phase II study designed to investigate the efficacy and safety of ublituximab and umbralisib combined with venetoclax in subjects with 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Venetoclax

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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.
Contacts and Locations
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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
La Jolla, California, United States, 92093
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, Kansas
TG Therapeutics Investigational Trial Site Recruiting
Westwood, Kansas, United States, 66210
United States, Minnesota
TG Therapeutics Investigational Trial Site Recruiting
Rochester, Minnesota, United States, 55905
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, Tennessee
TG Therapeutics Investigational Trial Site Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
TG Therapeutics, Inc.
More Information
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03801525     History of Changes
Other Study ID Numbers: U2-VEN-207
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
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
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs