Chronic Lymphocytic LeukemiaPhase 2NCT02742090
Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy
A Phase 2 study testing Umbralisib in people with Chronic Lymphocytic Leukemia, run by TG Therapeutics, Inc. at 15 sites in United States.
Trial summary
The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Umbralisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 Apr 2016to 10 Jun 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
- Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
- Presence of measurable disease
Who cannot join
- Progression on prior BTK or PI3K delta inhibitor
- Prior treatment with TGR-1202
- Richter's transformation or CLL transformation to aggressive lymphoma
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
TG Therapeutics Investigational Trial Site
Durham, North Carolina, 27710
TG Therapeutics Investigational Trial Site
Fort Myers, Florida, 33916
TG Therapeutics Investigational Trial Site
Hackensack, New Jersey, 07601
TG Therapeutics Investigational Trial Site
Hershey, Pennsylvania, 17033
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, 35805
TG Therapeutics Investigational Trial Site
Kansas City, Missouri, 64132
TG Therapeutics Investigational Trial Site
Lebanon, New Hampshire, 03756
TG Therapeutics Investigational Trial Site
Nashville, Tennessee, 37203
TG Therapeutics Investigational Trial Site
New Hyde Park, New York, 11042
TG Therapeutics Investigational Trial Site
New York, New York, 10032
TG Therapeutics Investigational Trial Site
Philadelphia, Pennsylvania, 19146
TG Therapeutics Investigational Trial Site
Rochester, New York, 14642
TG Therapeutics Investigational Trial Site
Seattle, Washington, 98104
TG Therapeutics Investigational Trial Site
St. Petersburg, Florida, 33705
TG Therapeutics Investigational Trial Site
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 (Umbralisib) in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy
The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Umbralisib
- Keywords
- CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UmbralisibDrug
Also called TGR-1202
Umbralisib was administered as a tablet(s), orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Umbralisib | Experimental | Participants received 800 milligrams (mg) of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months. Receives: Drug: Umbralisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
PFS was defined as the interval from Day 1 to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. Participants who had no event (progression or death) were censored at the day of their last adequate disease assessment.
Measured: From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)
Secondary outcomes (4)
Overall Response Rate (ORR)
ORR=percent of participants who achieve complete response (CR), or partial response (PR).
Measured: Up to 61.7 months
Time to Treatment Failure (TTF)
TTF is defined as a composite endpoint measuring time from Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. Estimates of median TTF was made using Kaplan-Meier methods.
Measured: From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months)
Duration of Response (DOR)
DOR defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. Estimates of median DOR was made using Kaplan-Meier methods.
Measured: From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAE's) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related. TEAEs included both serious and non-serious TEAEs.
Measured: From first dose of study treatment up to end of study (up to 61.7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study start21 Apr 2016
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Why it stopped: (Strategic/Business Decision)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- 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
- Investigators
- Anthony Mato, MD, Study chair, University of Pennsylvania Center for CLL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742090
- Sponsor's protocol ID
- TGR-1202-201-CLL
- Status last verified
- Jun 2024
- First submitted
- 11 Apr 2016
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be available upon study closure or as the study evolves
Publications
Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. doi: 10.1182/blood-2016-05-716977. Epub 2016 Sep 6.
PubMed 27601462
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 (Umbralisib) in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT02742090
- Acronym / sponsor ID
- TGR-1202-201-CLL
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CLL
- 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
- 21 Apr 2016 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Umbralisib | Experimental | Drug: UmbralisibParticipants received 800 milligrams (mg) of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
- Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
- Presence of measurable disease
Key exclusion criteria (3 listed)
- Progression on prior BTK or PI3K delta inhibitor
- Prior treatment with TGR-1202
- Richter's transformation or CLL transformation to aggressive lymphoma
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 |
|---|---|---|
| UmbralisibAlso: TGR-1202Umbralisib was administered as a tablet(s), orally once daily. | Drug | Umbralisib |
Primary outcome
Progression-free Survival
Time frame: From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)
PFS was defined as the interval from Day 1 to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. Participants who had no event (progression or death) were censored at the day of their last adequate disease assessment.
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 61.7 months
Time to Treatment Failure (TTF)
Time frame: From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months)
Duration of Response (DOR)
Time frame: From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAE's) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
Time frame: From first dose of study treatment up to end of study (up to 61.7 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27601462Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. doi: 10.1182/blood-2016-05-716977. Epub 2016 Sep 6.
- Individual participant dataSharing planned: Yes. Data will be available upon study closure or as the study evolves
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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.
Anthony Mato, MD study chair
University of Pennsylvania Center for CLL
15 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 Umbralisib in people with Chronic Lymphocytic Leukemia, run by TG Therapeutics, Inc. at 15 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 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 3 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 15 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?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free Survival (time frame: From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742090, which also lists 1 linked publication.
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 3 Jul 2024.