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NCT03671590 Clinical Trial

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

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03671590
Other study ID # TG-1701-101
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date September 10, 2018
Est. completion date June 1, 2024

Study information
Verified date May 2024
Source TG Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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. As per protocol v6.0, combination therapy (TG-1701 + Ublituximab + Umbralisib) will be discontinued and the participants from Arm 1 and 2 will be transitioned to the long-term extension period to receive TG-1701 monotherapy.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 172
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TG-1701
Oral daily dose
• Umbralisib
Oral Daily Dose
Biological:
• Ublituximab
IV infusion

Locations
Country Name City State
Australia TG Therapeutics Investigational Trial Site Adelaide
Australia TG Therapeutics Investigational Trial Site East Melbourne Victoria
Australia TG Therapeutics Investigational Trial Site Fitzroy Victoria
Australia TG Therapeutics Investigational Trial Site Nedlands Western Australia
Poland TG Therapeutics Investigational Trial Site Kraków
Poland TG Therapeutics Investigational Trial Site Lublin
Poland TG Therapeutics Investigational Trial Site Warszawa
Poland TG Therapeutics Investigational Trial Site Wroclaw

Sponsors (1)
Lead Sponsor Collaborator
TG Therapeutics, Inc.

Countries where clinical trial is conducted

Australia,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose acceptable for participants To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities. From first dose up to 30 days post last dose (Up to approximately 4.8 years)
Secondary Overall Response Rate To assess the overall response rate (ORR) in patients with hematologic malignancies Up to approximately 4.8 years
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