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

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ClinicalTrials.gov Identifier: NCT03801525
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
ULTRA-V: Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL)

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Ublituximab Drug: Umbralisib Drug: Venetoclax Phase 2 Phase 3

Detailed Description:
This is an open-label, multicenter, Phase 2/3 study to evaluate the efficacy and safety of the combination of ublituximab + umbralisib + venetoclax (U2-V) compared to the combination of ublituximab + umbralisib (U2) in patients with either treatment naïve or previously treated CLL

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects With Chronic Lymphocytic Leukemia (CLL)
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : March 1, 2025


Arm Intervention/treatment
Experimental: ublituximab + umbralisib + venetoclax Drug: Ublituximab
  • recombinant chimeric anti-CD20 monoclonal antibody
  • administered as an IV infusion
Other Name: TG-1101

Drug: Umbralisib
  • PI3K delta inhibitor
  • Tablet form
Other Name: TGR-1202

Drug: Venetoclax
  • BCL-2 inhibitor
  • Tablet form, to be taken orally
Other Name: Venclexta

Experimental: ublituximab + umbralisib Drug: Ublituximab
  • recombinant chimeric anti-CD20 monoclonal antibody
  • administered as an IV infusion
Other Name: TG-1101

Drug: Umbralisib
  • PI3K delta inhibitor
  • Tablet form
Other Name: TGR-1202




Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 60 months ]
    Progression-Free Survival in subjects treated with U2+V compared with U2


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

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



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.
  • Prior exposure to any PI3K inhibitor or venetoclax
  • 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 1-877-555-8489 clinicalsupport@tgtxinc.com

Locations
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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 15, 2021
Last Verified: October 2021
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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Venetoclax
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
Antineoplastic Agents