Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy

June 7, 2024 updated by: TG Therapeutics, Inc.

A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 (Umbralisib) in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy

The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • TG Therapeutics Investigational Trial Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • TG Therapeutics Investigational Trial Site
    • Florida
      • Fort Myers, Florida, United States, 33916
        • TG Therapeutics Investigational Trial Site
      • Saint Petersburg, Florida, United States, 33705
        • TG Therapeutics Investigational Trial Site
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • TG Therapeutics Investigational Trial Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • TG Therapeutics Investigational Trial Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • TG Therapeutics Investigational Trial Site
    • New York
      • New Hyde Park, New York, United States, 11042
        • TG Therapeutics Investigational Trial Site
      • New York, New York, United States, 10032
        • TG Therapeutics Investigational Trial Site
      • Rochester, New York, United States, 14642
        • TG Therapeutics Investigational Trial Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • TG Therapeutics Investigational Trial Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • TG Therapeutics Investigational Trial Site
      • Philadelphia, Pennsylvania, United States, 19146
        • TG Therapeutics Investigational Trial Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • TG Therapeutics Investigational Trial Site
    • Washington
      • Seattle, Washington, United States, 98104
        • TG Therapeutics Investigational Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
  • Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
  • Presence of measurable disease

Exclusion Criteria:

  • Progression on prior BTK or PI3K delta inhibitor
  • Prior treatment with TGR-1202
  • Richter's transformation or CLL transformation to aggressive lymphoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Umbralisib
Participants received 800 milligrams (mg) of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months.
Drug: Umbralisib
Umbralisib was administered as a tablet(s), orally once daily.
Other Names:
  • TGR-1202

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)
PFS was defined as the interval from Day 1 to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. Participants who had no event (progression or death) were censored at the day of their last adequate disease assessment.
From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to 61.7 months
ORR=percent of participants who achieve complete response (CR), or partial response (PR).
Up to 61.7 months
Time to Treatment Failure (TTF)
Time Frame: From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months)
TTF is defined as a composite endpoint measuring time from Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. Estimates of median TTF was made using Kaplan-Meier methods.
From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months)
Duration of Response (DOR)
Time Frame: From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months)
DOR defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. Estimates of median DOR was made using Kaplan-Meier methods.
From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAE's) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
Time Frame: From first dose of study treatment up to end of study (up to 61.7 months)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related. TEAEs included both serious and non-serious TEAEs.
From first dose of study treatment up to end of study (up to 61.7 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Investigators

  • Study Chair: Anthony Mato, MD, University of Pennsylvania Center for CLL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2016

Primary Completion (Actual)

June 10, 2021

Study Completion (Actual)

June 10, 2021

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimated)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGR-1202-201-CLL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available upon study closure or as the study evolves

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Lymphocytic Leukemia

Clinical Trials on Umbralisib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe