Non-Hodgkin's LymphomaPhase 1NCT01767766
Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
A Phase 1 study testing TGR-1202 in people with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, run by TG Therapeutics, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Peripheral T-Cell Lymphoma
- What is being tested?
- TGR-1202
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Jan 2013to Feb 2018
- 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
- Refractory to or relapsed after at least 1 prior treatment regimen;
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2;
- At least 18 years of age.
Who cannot join
- Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks);
- Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months;
- Known hepatitis B virus, hepatitis C virus or HIV infection;
- Previous therapy with GS-1101 (CAL-101), IPI-145 or any drug that specifically inhibits the PI3K or mTOR pathway;
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
TG Therapeutics Trial Site
Cincinnati, Ohio, 45242
TG Therapeutics Trial Site
Durham, North Carolina, 27710
TG Therapeutics Trial Site
Hackensack, New Jersey, 07601
TG Therapeutics Investigational Trial Site
Milwaukee, Wisconsin, 53226
TG Therapeutics Trial Site
Nashville, Tennessee, 37203
TG Therapeutics Trial Site
New York, New York, 10019
TG Therapeutics Trial Site
Sarasota, Florida, 34232
About this study
Official title: A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.
- Conditions
- Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Peripheral T-Cell Lymphoma, Hodgkin's Lymphoma
- Being tested
- TGR-1202
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, T-Cell, Peripheral, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGR-1202Drug
TGR-1202 Daily Oral Dose
| Study group | Role | What they receive |
|---|---|---|
| TGR-1202 | Experimental | TGR-1202 Daily Oral Dose Receives: Drug: TGR-1202 |
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: 28 days (1 cycle of therapy)
Secondary outcomes (1)
Overall Response Rate
To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study start7 Jan 2013
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Responsible party
- Sponsor
- Investigators
- Howard Burris, MD, FACP, Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767766
- Sponsor's protocol ID
- TGR-1202-101 (HEMREF 31)
- Status last verified
- Aug 2021
- First submitted
- 9 Jan 2013
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Burris HA 3rd, Flinn IW, Patel MR, Fenske TS, Deng C, Brander DM, Gutierrez M, Essell JH, Kuhn JG, Miskin HP, Sportelli P, Weiss MS, Vakkalanka S, Savona MR, O'Connor OA. Umbralisib, a novel PI3Kdelta and casein kinase-1epsilon inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study. Lancet Oncol. 2018 Apr;19(4):486-496. doi: 10.1016/S1470-2045(18)30082-2. Epub 2018 Feb 20.
PubMed 29475723
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT01767766
- Acronym / sponsor ID
- TGR-1202-101 (HEMREF 31)
- Conditions
- Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Peripheral T-Cell Lymphoma, Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Study start
- 7 Jan 2013 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 14 Jan 2013 (estimated)
- 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.
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TGR-1202 | Experimental | Drug: TGR-1202TGR-1202 Daily Oral Dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Refractory to or relapsed after at least 1 prior treatment regimen;
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2;
- At least 18 years of age.
Key exclusion criteria (4 listed)
- Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks);
- Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months;
- Known hepatitis B virus, hepatitis C virus or HIV infection;
- Previous therapy with GS-1101 (CAL-101), IPI-145 or any drug that specifically inhibits the PI3K or mTOR pathway;
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-1202TGR-1202 Daily Oral Dose | Drug | TGR-1202 |
Primary outcome
Maximum Tolerated Dose acceptable for participants
Time frame: 28 days (1 cycle of therapy)
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 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Derived from this study: PubMed 29475723Burris HA 3rd, Flinn IW, Patel MR, Fenske TS, Deng C, Brander DM, Gutierrez M, Essell JH, Kuhn JG, Miskin HP, Sportelli P, Weiss MS, Vakkalanka S, Savona MR, O'Connor OA. Umbralisib, a novel PI3Kdelta and casein kinase-1epsilon inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study. Lancet Oncol. 2018 Apr;19(4):486-496. doi: 10.1016/S1470-2045(18)30082-2. Epub 2018 Feb 20.
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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.
Howard Burris, MD, FACP study chair
SCRI Development Innovations, LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TGR-1202 in people with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, run by TG Therapeutics, Inc. at 7 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 4 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: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 28 days (1 cycle of therapy)). 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 NCT01767766, 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 23 Aug 2021.