Chronic Lymphocytic LeukemiaPhase 2NCT03207256
Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials
A Phase 2 study testing TGR-1202 and TGR-1202 + Ublituximab in people with Chronic Lymphocytic Leukemia and Non Hodgkin Lymphoma, run by TG Therapeutics, Inc. at 17 sites in United States.
Trial summary
This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
- What is being tested?
- TGR-1202 and TGR-1202 + 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
- 51 participants
- Where
- 17 sitesUnited States
- Study dates
- 9 Aug 2017to 24 Jun 2022
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol.
- Subjects must have completed at least 6 cycles of therapy on their current protocol.
Who cannot join
- Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
TG Therapeutics Investigational Trial Site
Atlanta, Georgia, 30322
TG Therapeutics Investigational Site
Canton, Ohio, 44718
TG Therapeutics Investigational Trial Site
Cincinnati, Ohio, 45242
TG Therapeutics Investigational Trial Site
Coon Rapids, Minnesota, 55433
TG Therapeutics Investigational Trial Site
Denton, Texas, 76210
TG Therapeutics Investigational Trial Site
Duarte, California, 91010
TG Therapeutics Investigational Trial Site
Durham, North Carolina, 27710
TG Therapeutics Investigational Trial Site
Fayetteville, Arkansas, 72703
TG Therapeutics Investigational Trial Site
Fort Myers, Florida, 33901
TG Therapeutics Investigational Trial Site
Fort Wayne, Indiana, 46804
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, 35805
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin, 53226
TG Therapeutics Investigational Trial Site
Nashville, Tennessee, 37203
TG Therapeutics Investigational Trial Site
Omaha, Nebraska, 68198
TG Therapeutics Investigational Trial Site
San Antonio, Texas, 78229
TG Therapeutics Investigational Trial Site
Seattle, Washington, 98104
TG Therapeutics Investigational Trial Site
Tucson, Arizona, 85711
About this study
Official title: An Open Label Extension Trial of Ublituximab and/or Umbralisib (TGR-1202) in Combination With Other Novel Agents or as Single Agents in Subjects Currently Receiving Treatment on a TG Therapeutics Study.
This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia.
- Conditions
- Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
- Being tested
- TGR-1202, TGR-1202 + Ublituximab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGR-1202Drug
Oral Daily TGR-1202
TGR-1202 + UblituximabDrug
Oral Daily TGR-1202 + Ublituximab IV Administration
| Study group | Role | What they receive |
|---|---|---|
| TGR-1202 | Experimental | Oral TGR-1202 Daily Receives: Drug: TGR-1202 |
| TGR-1202 + Ublituximab | Experimental | Oral TGR-1202 in combination with Ublituximab intravenous administration Receives: Drug: TGR-1202 + Ublituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities
Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)
Measured: Evaluated at each planned visit through study completion, an average of 2 years
Secondary outcomes (1)
Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment
Date of progression reported for each patient
Measured: Evaluated at each planned visit through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start9 Aug 2017
- Primary completion25 May 2022
- Study completion24 Jun 2022
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 Chronic Lymphocytic LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207256
- Sponsor's protocol ID
- UTX-TGR-501
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2017
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Extension Trial of Ublituximab and/or Umbralisib (TGR-1202) in Combination With Other Novel Agents or as Single Agents in Subjects Currently Receiving Treatment on a TG Therapeutics Study.
- ClinicalTrials.gov ID
- NCT03207256
- Acronym / sponsor ID
- UTX-TGR-501
- Conditions
- Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic/Business Decision
- Enrolment
- 51 participants (actual)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 2 Jul 2017 (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 an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TGR-1202 | Experimental | Drug: TGR-1202Oral TGR-1202 Daily |
| TGR-1202 + Ublituximab | Experimental | Drug: TGR-1202 + UblituximabOral TGR-1202 in combination with Ublituximab intravenous administration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol.
- Subjects must have completed at least 6 cycles of therapy on their current protocol.
Key exclusion criteria (1 listed)
- Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.
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 |
|---|---|---|
| TGR-1202Oral Daily TGR-1202 | Drug | TGR-1202 |
| TGR-1202 + UblituximabOral Daily TGR-1202 + Ublituximab IV Administration | Drug | TGR-1202 + Ublituximab |
Primary outcome
Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities
Time frame: Evaluated at each planned visit through study completion, an average of 2 years
Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)
1 secondary outcome
Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment
Time frame: Evaluated at each planned visit through study completion, an average of 2 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 21 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TGR-1202 and TGR-1202 + Ublituximab in people with Chronic Lymphocytic Leukemia and Non Hodgkin Lymphoma, run by TG Therapeutics, Inc. at 17 sites in United States.
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 2 inclusion and 1 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 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities (time frame: Evaluated at each planned visit through study completion, an average of 2 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 21 Jul 2022.