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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03671590
Ethics application status
Date submitted
12/09/2018
Date registered
14/09/2018

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
Treatment: Other - Ublituximab

Experimental: 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.

Experimental: 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.

Experimental: 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.


Treatment: Drugs: TG-1701
Oral daily dose

Treatment: Drugs: Umbralisib
Oral Daily Dose

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

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose acceptable for participants
Timepoint [1] 0 0
From first dose up to 30 days post last dose (Up to approximately 4.8 years)
Secondary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
Up to approximately 4.8 years

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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/05/2024
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
TG Therapeutics Investigational Trial Site - East Melbourne
Recruitment hospital [2] 0 0
TG Therapeutics Investigational Trial Site - Fitzroy
Recruitment hospital [3] 0 0
TG Therapeutics Investigational Trial Site - Nedlands
Recruitment hospital [4] 0 0
TG Therapeutics Investigational Trial Site - Adelaide
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Nedlands
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Poland
State/province [1] 0 0
Kraków
Country [2] 0 0
Poland
State/province [2] 0 0
Lublin
Country [3] 0 0
Poland
State/province [3] 0 0
Warszawa
Country [4] 0 0
Poland
State/province [4] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03671590