Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
- Conditions
- Non Hodgkin LymphomaChronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT03671590
- Lead Sponsor
- TG Therapeutics, Inc.
- 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.
- 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. 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 & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 172
- Relapsed or refractory histologically confirmed B-cell lymphoma or CLL
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- Adequate organ function
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: TG-1701 Monotherapy TG-1701 Participants will receive TG-1701 oral daily dose. As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy. Arm 2: TG-1701 + Ublituximab + Umbralisib TG-1701 Participants will receive TG-1701, oral dose in combination with ublituximab, oral dose and umbralisib, fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days). As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy. Arm 2: TG-1701 + Ublituximab + Umbralisib Ublituximab Participants will receive TG-1701, oral dose in combination with ublituximab, oral dose and umbralisib, fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days). As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy. Arm 3: Long Term Safety Extension - TG-1701 Monotherapy TG-1701 All the ongoing participants from Arm 1 and 2, will be transitioned to TG-1701 monotherapy in long-term extension period, per protocol version 6.0. Arm 2: TG-1701 + Ublituximab + Umbralisib Umbralisib Participants will receive TG-1701, oral dose in combination with ublituximab, oral dose and umbralisib, fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days). As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy.
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose acceptable for participants 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
Name Time Method Overall Response Rate Up to approximately 4.8 years To assess the overall response rate (ORR) in patients with hematologic malignancies
Trial Locations
- Locations (1)
TG Therapeutics Investigational Trial Site
🇵🇱Wrocław, Poland