Chronic Lymphocytic LeukemiaPhase 1NCT02535286
Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation
A Phase 1 study testing Umbralisib, ublituximab and TG-1501 in people with Chronic Lymphocytic Leukemia and Richter Syndrome, run by TG Therapeutics, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Richter Syndrome
- What is being tested?
- Umbralisib, ublituximab and TG-1501
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Sep 2015to 4 Nov 2021
- 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
- Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
- Refractory to or relapsed after at least 1 prior treatment regimen
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Who cannot join
- Any major surgery, chemotherapy or immunotherapy within the last 14 days
- Known hepatitis B virus, hepatitis C virus or HIV infection
- Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
TG Therapeutics Investigational Trial Site
Durham, North Carolina, 27710
TG Therapeutics Investigational Trial Site
New York, New York, 10065
TG Therapeutics Investigational Trial Site
Philadelphia, Pennsylvania, 19104
TG Therapeutics Investigational Trial Site
Seattle, Washington, 98109
About this study
Official title: Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL
The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.
- Conditions
- Chronic Lymphocytic Leukemia, Richter Syndrome
- Being tested
- Umbralisib, ublituximab, TG-1501
- 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
A once daily oral agent
ublituximabBiological
Also called TG-1101
IV anti-CD20 monoclonal antibody
TG-1501Biological
IV immunotherapy for cancer
| Study group | Role | What they receive |
|---|---|---|
| TG-1501 + Ublituximab + Umbralisib | Experimental | Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals Receives: Drug: Umbralisib; Biological: ublituximab; Biological: TG-1501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Acceptable Adverse Events That Are Related to Treatment
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Measured: 6 months of therapy
Secondary outcomes (1)
Overall Response Rate
The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy
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 posted28 Aug 2015 (estimated)
- Study start18 Sep 2015
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Anthony R. Mato, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535286
- Sponsor's protocol ID
- TG-UPCC-108
- Status last verified
- Oct 2022
- First submitted
- 24 Aug 2015
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL
- ClinicalTrials.gov ID
- NCT02535286
- Acronym / sponsor ID
- TG-UPCC-108
- Conditions
- Chronic Lymphocytic Leukemia, Richter Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- 18 Sep 2015 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 28 Aug 2015 (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 targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TG-1501 + Ublituximab + Umbralisib | Experimental | Drug: Umbralisib, Biological: ublituximab, Biological: TG-1501Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals |
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 B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
- Refractory to or relapsed after at least 1 prior treatment regimen
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Key exclusion criteria (3 listed)
- Any major surgery, chemotherapy or immunotherapy within the last 14 days
- Known hepatitis B virus, hepatitis C virus or HIV infection
- Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
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-1202A once daily oral agent | Drug | TG-1501 + Ublituximab + Umbralisib |
| ublituximabAlso: TG-1101IV anti-CD20 monoclonal antibody | Biological | TG-1501 + Ublituximab + Umbralisib |
| TG-1501IV immunotherapy for cancer | Biological | TG-1501 + Ublituximab + Umbralisib |
Primary outcome
Determine Acceptable Adverse Events That Are Related to Treatment
Time frame: 6 months 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 20 Oct 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.
Anthony R. Mato, MD study chair
Memorial Sloan Kettering Cancer Center
4 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 Umbralisib, ublituximab and TG-1501 in people with Chronic Lymphocytic Leukemia and Richter Syndrome, run by TG Therapeutics, Inc. at 4 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: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Determine Acceptable Adverse Events That Are Related to Treatment (time frame: 6 months of therapy). 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 20 Oct 2022.