Chronic Lymphocytic LeukemiaPhase 1/2NCT02013128
Ublituximab + Ibrutinib in Select B-cell Malignancies
A Phase 1/2 study testing Ublituximab and Ibrutinib in people with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, run by TG Therapeutics, Inc. at 18 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib 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
- Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
- What is being tested?
- Ublituximab and Ibrutinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 18 sitesUnited States
- Study dates
- 6 Jan 2014to Dec 2015
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed.
- 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 21 days
- Known hepatitis B virus, hepatitis C virus or HIV infection
- Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded.
- Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
TG Therapeutics Investigational Trial Site
Austin, Texas, 78705
TG Therapeutics Investigational Trial Site
Bethesda, Maryland, 20817
TG Therapeutics Investigational Trial Site
Blacksburg, Virginia, 24060
TG Therapeutics Investigational Trial Site
Boulder, Colorado, 80303
TG Therapeutics Investigational Trial Site
Dallas, Texas, 75230
TG Therapeutics Investigational Trial Site
Fairfax, Virginia, 22031
TG Therapeutics Investigational Trial Site
Greenville, South Carolina, 29615
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, 35805
TG Therapeutics Investigational Trial Site
Memphis, Tennessee, 38120
TG Therapeutics Investigational Trial Site
Morristown, New Jersey, 07962
TG Therapeutics Investigational Trial Site
Niles, Illinois, 60714
TG Therapeutics Investigational Trial Site
Portland, Oregon, 97213
TG Therapeutics Investigational Trial Site
Santa Barbara, California, 93105
TG Therapeutics Investigational Trial Site
Springfield, Oregon, 97477
TG Therapeutics Investigational Trial Site
Tucson, Arizona, 85710
TG Therapeutics Investigational Trial Site
Tyler, Texas, 75702
TG Therapeutics Investigational Trial Site
Urbana, Illinois, 61801
TG Therapeutics Investigational Trial Site
Vancouver, Washington, 98684
About this study
Official title: A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.
- Conditions
- Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
- Being tested
- Ublituximab, Ibrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabDrug
Ublituximab (IV infusion)
IbrutinibDrug
Also called Ibrutinib (IMBRUVICA)
Ibrutinib oral daily dose
| Study group | Role | What they receive |
|---|---|---|
| Ublituximab + ibrutinib | Experimental | Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose Receives: Drug: Ublituximab; Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies
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 Ublituximab in combination with Ibrutinib
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 posted17 Dec 2013 (estimated)
- Study start6 Jan 2014
- Primary completionDec 2015
- Study completionDec 2015
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Sharman, MD, Study chair, Willamette Valley Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013128
- Sponsor's protocol ID
- UTX-IB-104
- Status last verified
- Oct 2022
- First submitted
- 11 Dec 2013
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies
- ClinicalTrials.gov ID
- NCT02013128
- Acronym / sponsor ID
- UTX-IB-104
- Conditions
- Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Dec 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 Ublituximab in combination with Ibrutinib 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 |
|---|---|---|
| Ublituximab + ibrutinib | Experimental | Drug: Ublituximab, Drug: IbrutinibUblituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily 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)
- Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed.
- Refractory to or relapsed after at least 1 prior treatment regimen
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Key exclusion criteria (4 listed)
- Any major surgery, chemotherapy or immunotherapy within the last 21 days
- Known hepatitis B virus, hepatitis C virus or HIV infection
- Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded.
- Richter's transformation, prolymphocytic leukemia or primary central nervous system 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 |
|---|---|---|
| UblituximabUblituximab (IV infusion) | Drug | Ublituximab + ibrutinib |
| IbrutinibAlso: Ibrutinib (IMBRUVICA)Ibrutinib oral daily dose | Drug | Ublituximab + ibrutinib |
Primary outcome
To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies
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 24 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.
Jeff Sharman, MD study chair
Willamette Valley Cancer Institute
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ublituximab and Ibrutinib in people with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, run by TG Therapeutics, Inc. at 18 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 24 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 18 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 combined 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.
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 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?
To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies (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?
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 24 Oct 2022.