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Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671590
Recruitment Status : Active, not recruiting
First Posted : September 14, 2018
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Study Description
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Brief Summary:
This is a Phase 1 trial to evaluate the safety, pharmacokinetics and efficacy of TG-1701, a Bruton's Tyrosine Kinase (BTK) inhibitor in patients with relapsed or refractory B-cell malignancies

Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Chronic Lymphocytic Leukemia Drug: TG-1701 Drug: Umbralisib Biological: Ublituximab Phase 1

Detailed Description:
This Phase I clinical trial aims to evaluate the safety of the investigational drug TG-1701 both as a single-agent and in combination with other investigational drugs, specifically ublituximab and umbralisib.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
TG-1701 oral daily dose
 Drug: TG-1701
Oral daily dose
Experimental: Arm 2
TG-1701 + Ublituximab + Umbralisib
 Drug: TG-1701
Oral daily dose

Drug: Umbralisib
Oral Daily Dose
Other Name: TGR-1202

Biological: Ublituximab
Ublituximab at a fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days)
Other Name: TG-1101


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose acceptable for participants [ Time Frame: From first dose up to 30 days post last dose (Up to approximately 4.8 years) ]
    To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to approximately 4.8 years ]
    To assess the overall response rate (ORR) in patients with hematologic malignancies


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:

  • Relapsed or refractory histologically confirmed B-cell lymphoma or CLL
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
  • Adequate organ function

Exclusion Criteria:

  • Prior therapy with a BTK inhibitor (ibrutinib, acalabrutinib, other)
  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Known hepatitis B virus, hepatitis C virus or HIV infection
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): NCT03671590


Locations
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Australia, Victoria
TG Therapeutics Investigational Trial Site
East Melbourne, Victoria, Australia
TG Therapeutics Investigational Trial Site
Fitzroy, Victoria, Australia
Australia, Western Australia
TG Therapeutics Investigational Trial Site
Nedlands, Western Australia, Australia
Australia
TG Therapeutics Investigational Trial Site
Adelaide, Australia
Poland
TG Therapeutics Investigational Trial Site
Kraków, Poland, 30-510
TG Therapeutics Investigational Trial Site
Lublin, Poland, 20-090
TG Therapeutics Investigational Trial Site
Warszawa, Poland, 02-781
TG Therapeutics Investigational Trial Site
Wrocław, Poland, 50-367
Sponsors and Collaborators
TG Therapeutics, Inc.
Investigators
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Study Chair: Constantine S. Tam, MD St. Vincents Hospital
More Information
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03671590    
Other Study ID Numbers: TG-1701-101
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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