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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03671590




Registration number
NCT03671590
Ethics application status
Date submitted
12/09/2018
Date registered
14/09/2018
Date last updated
8/07/2020

Titles & IDs
Public title
Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Scientific title
A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Secondary ID [1] 0 0
TG-1701-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Hodgkin Lymphoma 0 0
Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TG-1701
Treatment: Drugs - Umbralisib
Other interventions - Ublituximab

Experimental: Arm 1 - TG-1701 oral daily dose

Experimental: Arm 2 - TG-1701 + Ublituximab + Umbralisib


Treatment: Drugs: TG-1701
Oral daily dose

Treatment: Drugs: Umbralisib
Oral Daily Dose

Other interventions: Ublituximab
Ublituximab at a fixed IV infusion on specific Days, followed by maintenance infusions

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose acceptable for participants - To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Timepoint [1] 0 0
28 days (1 cycle of therapy)
Secondary outcome [1] 0 0
Overall Response Rate - To assess the overall response rate (ORR) in patients with hematologic malignancies
Timepoint [1] 0 0
Up to 1 year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
TG Therapeutics Investigational Trial Site - Adelaide
Recruitment hospital [2] 0 0
TG Therapeutics Investigational Trial Site - Fitzroy
Recruitment hospital [3] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [4] 0 0
TG Therapeutics Investigational Trial Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Poland
State/province [1] 0 0
Kraków
Country [2] 0 0
Poland
State/province [2] 0 0
Warszawa
Country [3] 0 0
Poland
State/province [3] 0 0
Wroclaw

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
TG Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT03671590
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Constantine S. Tam, MD
Address 0 0
St. Vincents Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
TG Therapeutics Clinical Support Team
Address 0 0
Country 0 0
Phone 0 0
212-554-4484
Fax 0 0
Email 0 0
clinicalsupport@tgtxinc.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03671590