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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-10

Study Completion Date

2024-05-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non Hodgkin Lymphoma Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: TG-1701 Monotherapy

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.

Group Type EXPERIMENTAL

TG-1701

Intervention Type DRUG

Oral daily dose

Arm 2: TG-1701 + Ublituximab + 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.

Group Type EXPERIMENTAL

TG-1701

Intervention Type DRUG

Oral daily dose

Umbralisib

Intervention Type DRUG

Oral Daily Dose

Ublituximab

Intervention Type BIOLOGICAL

IV infusion

Arm 3: Long Term Safety Extension - TG-1701 Monotherapy

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.

Group Type EXPERIMENTAL

TG-1701

Intervention Type DRUG

Oral daily dose

Interventions

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TG-1701

Oral daily dose

Intervention Type DRUG

Umbralisib

Oral Daily Dose

Intervention Type DRUG

Ublituximab

IV infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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TGR-1202 TG-1101

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No