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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

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ClinicalTrials.gov Identifier: NCT04016805
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2023


Arm Intervention/treatment
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

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

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

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




Primary Outcome Measures :
  1. Rate of minimal residual disease negativity [ Time Frame: 24 months ]
    Assess the rate of undetectable minimal residual disease (U-MRD)


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 24 months ]
    Objective response in subjects treated on study

  2. Adverse Events that are Related to Treatment [ Time Frame: 12 months ]
    Number of Participants With Treatment-Related Adverse Events



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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:

  • 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.

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): NCT04016805


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

Sponsors and Collaborators
TG Therapeutics, Inc.

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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04016805     History of Changes
Other Study ID Numbers: UTX-TGR-208
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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.:
umbralisib
ublituximab
venetoclax
ibrutinib
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