Back to resultsStudy of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Primary Purpose
Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TG-1701
Umbralisib
Ublituximab
Sponsored by
About this trial
This is an interventional treatment trial for Non Hodgkin Lymphoma
Eligibility 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
Sites / Locations
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1: TG-1701 Monotherapy
Arm 2: TG-1701 + Ublituximab + Umbralisib
Arm 3: Long Term Safety Extension - TG-1701 Monotherapy
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose acceptable for participants
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Secondary Outcome Measures
Overall Response Rate
To assess the overall response rate (ORR) in patients with hematologic malignancies
Full Information
NCT ID
NCT03671590
First Posted
September 12, 2018
Last Updated
October 18, 2023
Sponsor
TG Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03671590
Brief Title
Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: TG-1701 Monotherapy
Arm Type
Experimental
Arm Description
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 Title
Arm 2: TG-1701 + Ublituximab + Umbralisib
Arm Type
Experimental
Arm Description
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 Title
Arm 3: Long Term Safety Extension - TG-1701 Monotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TG-1701
Intervention Description
Oral daily dose
Intervention Type
Drug
Intervention Name(s)
Umbralisib
Other Intervention Name(s)
TGR-1202
Intervention Description
Oral Daily Dose
Intervention Type
Biological
Intervention Name(s)
Ublituximab
Other Intervention Name(s)
TG-1101
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose acceptable for participants
Description
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Time Frame
From first dose up to 30 days post last dose (Up to approximately 4.8 years)
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
To assess the overall response rate (ORR) in patients with hematologic malignancies
Time Frame
Up to approximately 4.8 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantine S. Tam, MD
Organizational Affiliation
St. Vincents Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
East Melbourne
State/Province
Victoria
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Adelaide
Country
Australia
Facility Name
TG Therapeutics Investigational Trial Site
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
TG Therapeutics Investigational Trial Site
City
Wrocław
ZIP/Postal Code
50-367
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
We'll reach out to this number within 24 hrs