NCT03671590

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_1

Geographic Reach
2 countries

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

5.7 years

First QC Date

September 12, 2018

Last Update Submit

July 18, 2024

Conditions

Non Hodgkin LymphomaChronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Overall Response Rate

    Up to approximately 4.8 years

Study Arms (3)

Arm 1: TG-1701 Monotherapy

EXPERIMENTAL

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.

Drug: TG-1701

Arm 2: TG-1701 + Ublituximab + Umbralisib

EXPERIMENTAL

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.

Drug: TG-1701Drug: UmbralisibBiological: Ublituximab

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

EXPERIMENTAL

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.

Drug: TG-1701

Interventions

TG-1701DRUG

Oral daily dose

Arm 1: TG-1701 MonotherapyArm 2: TG-1701 + Ublituximab + UmbralisibArm 3: Long Term Safety Extension - TG-1701 Monotherapy
UmbralisibDRUG

Oral Daily Dose

Also known as: TGR-1202
Arm 2: TG-1701 + Ublituximab + Umbralisib
UblituximabBIOLOGICAL

IV infusion

Also known as: TG-1101
Arm 2: TG-1701 + Ublituximab + Umbralisib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

TG Therapeutics Investigational Trial Site

East Melbourne, Victoria, Australia

Location

TG Therapeutics Investigational Trial Site

Fitzroy, Victoria, Australia

Location

TG Therapeutics Investigational Trial Site

Nedlands, Western Australia, Australia

Location

TG Therapeutics Investigational Trial Site

Adelaide, Australia

Location

TG Therapeutics Investigational Trial Site

Krakow, 30-510, Poland

Location

TG Therapeutics Investigational Trial Site

Lublin, 20-090, Poland

Location

TG Therapeutics Investigational Trial Site

Warsaw, 02-781, Poland

Location

TG Therapeutics Investigational Trial Site

Wroclaw, 50-367, Poland

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

umbralisibublituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Constantine S. Tam, MD

    St. Vincents Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 14, 2018

Study Start

September 10, 2018

Primary Completion

May 21, 2024

Study Completion

May 21, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

AU(4)PL(4)