Non Hodgkin LymphomaPhase 1NCT03671590
Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
A Phase 1 study testing TG-1701, Umbralisib and Ublituximab in people with Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by TG Therapeutics, Inc. at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
- What is being tested?
- TG-1701, Umbralisib and Ublituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 10 Sep 2018to 21 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory histologically confirmed B-cell lymphoma or CLL
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- Adequate organ function
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Australia4 sites
TG Therapeutics Investigational Trial Site
Adelaide
TG Therapeutics Investigational Trial Site
East Melbourne, Victoria
TG Therapeutics Investigational Trial Site
Fitzroy, Victoria
TG Therapeutics Investigational Trial Site
Nedlands, Western Australia
Poland4 sites
TG Therapeutics Investigational Trial Site
Krakow, 30-510
TG Therapeutics Investigational Trial Site
Lublin, 20-090
TG Therapeutics Investigational Trial Site
Warsaw, 02-781
TG Therapeutics Investigational Trial Site
Wroclaw, 50-367
About this study
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
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.
Read the 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.
- Conditions
- Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
- Being tested
- TG-1701, Umbralisib, Ublituximab
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG-1701Drug
Oral daily dose
UmbralisibDrug
Also called TGR-1202
Oral Daily Dose
UblituximabBiological
Also called TG-1101
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: TG-1701; Drug: Umbralisib; Biological: 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. Receives: Drug: TG-1701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose acceptable for participants
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
Measured: From first dose up to 30 days post last dose (Up to approximately 4.8 years)
Secondary outcomes (1)
Overall Response Rate
To assess the overall response rate (ORR) in patients with hematologic malignancies
Measured: Up to approximately 4.8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start10 Sep 2018
- Primary completion21 May 2024
- Study completion21 May 2024
Why it stopped: Strategic/Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by TG Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Constantine S. Tam, MD, Study chair, St. Vincents Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671590
- Sponsor's protocol ID
- TG-1701-101
- Status last verified
- Jul 2024
- First submitted
- 12 Sep 2018
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03671590
- Acronym / sponsor ID
- TG-1701-101
- Conditions
- Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic/Business Decision
- Enrolment
- 172 participants (actual)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: TG-1701 Monotherapy | Experimental | Drug: TG-1701Participants 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 2: TG-1701 + Ublituximab + Umbralisib | Experimental | Drug: TG-1701, Drug: Umbralisib, Biological: UblituximabParticipants 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 3: Long Term Safety Extension - TG-1701 Monotherapy | Experimental | Drug: TG-1701All 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Relapsed or refractory histologically confirmed B-cell lymphoma or CLL
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- Adequate organ function
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG-1701Oral daily dose | Drug | Arm 1: TG-1701 Monotherapy, Arm 2: TG-1701 + Ublituximab + Umbralisib, Arm 3: Long Term Safety Extension - TG-1701 Monotherapy |
| UmbralisibAlso: TGR-1202Oral Daily Dose | Drug | Arm 2: TG-1701 + Ublituximab + Umbralisib |
| UblituximabAlso: TG-1101IV infusion | Biological | Arm 2: TG-1701 + Ublituximab + Umbralisib |
Primary outcome
Maximum Tolerated Dose acceptable for participants
Time frame: From first dose up to 30 days post last dose (Up to approximately 4.8 years)
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
1 secondary outcome
Overall Response Rate
Time frame: Up to approximately 4.8 years
Results and safety
The study was stopped early (reason given: Strategic/Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantine S. Tam, MD study chair
St. Vincents Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TG-1701, Umbralisib and Ublituximab in people with Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by TG Therapeutics, Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic/Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose acceptable for participants (time frame: From first dose up to 30 days post last dose (Up to approximately 4.8 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.