Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03671590
Registration number
NCT03671590
Ethics application status
Date submitted
12/09/2018
Date registered
14/09/2018
Date last updated
14/05/2024
Titles & IDs
Public title
Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Query!
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
Query!
Secondary ID [1]
0
0
TG-1701-101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non Hodgkin Lymphoma
0
0
Query!
Chronic Lymphocytic Leukemia
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - TG-1701
Treatment: Drugs - Umbralisib
Other interventions - 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
Other interventions: Ublituximab
IV infusion
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Maximum Tolerated Dose acceptable for participants
Query!
Assessment method [1]
0
0
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Query!
Timepoint [1]
0
0
From first dose up to 30 days post last dose (Up to approximately 4.8 years)
Query!
Secondary outcome [1]
0
0
Overall Response Rate
Query!
Assessment method [1]
0
0
To assess the overall response rate (ORR) in patients with hematologic malignancies
Query!
Timepoint [1]
0
0
Up to approximately 4.8 years
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/09/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/06/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
172
Query!
Recruitment in Australia
Recruitment state(s)
VIC,WA
Query!
Recruitment hospital [1]
0
0
TG Therapeutics Investigational Trial Site - East Melbourne
Query!
Recruitment hospital [2]
0
0
TG Therapeutics Investigational Trial Site - Fitzroy
Query!
Recruitment hospital [3]
0
0
TG Therapeutics Investigational Trial Site - Nedlands
Query!
Recruitment hospital [4]
0
0
TG Therapeutics Investigational Trial Site - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
- East Melbourne
Query!
Recruitment postcode(s) [2]
0
0
- Fitzroy
Query!
Recruitment postcode(s) [3]
0
0
- Nedlands
Query!
Recruitment postcode(s) [4]
0
0
- Adelaide
Query!
Recruitment outside Australia
Country [1]
0
0
Poland
Query!
State/province [1]
0
0
Kraków
Query!
Country [2]
0
0
Poland
Query!
State/province [2]
0
0
Lublin
Query!
Country [3]
0
0
Poland
Query!
State/province [3]
0
0
Warszawa
Query!
Country [4]
0
0
Poland
Query!
State/province [4]
0
0
Wroclaw
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
TG Therapeutics, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03671590
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Constantine S. Tam, MD
Query!
Address
0
0
St. Vincents Hospital
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03671590
Download to PDF