Non-Hodgkins LymphomaPhase 1/2NCT01647971
Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
A Phase 1/2 study testing Ublituximab in people with Non-Hodgkins Lymphoma and B-cell Lymphoma, run by TG Therapeutics, Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkins Lymphoma, B-cell Lymphoma, Waldenstrom's Macroglobulinemia
- What is being tested?
- Ublituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 8 sitesUnited States
- Study dates
- 19 Jul 2012to May 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
- Relapsed or Refractory B-cell Lymphoma
- Measurable or Evaluable Disease
- Previously treated with at least one line of rituximab or a rituximab based therapy
- Patients ineligible for high dose or combination chemotherapy + stem cell transplant
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- No active or chronic infection of Hepatitis B or C and no history of HIV based on negative serology
Who cannot join
- Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry
- Prior autologous or allogeneic stem cell transplantation within 3 months of study entry
- History of severe hypersensitivity or anaphylaxis to prior rituximab
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, brain metastasis, or psychiatric illness that would limit compliance with study requirements
- Pregnant women
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
TG Therapeutics Investigational Trial Site
Athens, Georgia, 30607
TG Therapeutics Investigational Trial Site
Bethesda, Maryland, 20817
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, 35805
TG Therapeutics Investigational Trial Site
Jonesboro, Arkansas, 72401
TG Therapeutics Investigational Trial Site
Macon, Georgia, 31201
TG Therapeutics Investigational Trial Site
Memphis, Tennessee, 38120
TG Therapeutics Investigational Trial Site
Morristown, New Jersey, 07962
TG Therapeutics Investigational Trial Site
New York, New York, 10022
About this study
Official title: An Open Label Phase I/II Study of the Efficacy and Safety of Ublituximab in Patients With B-cell Non-Hodgkin Lymphoma Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy
The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.
- Conditions
- Non-Hodgkins Lymphoma, B-cell Lymphoma, Waldenstrom's Macroglobulinemia, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
- Being tested
- Ublituximab
- Keywords
- Lymphoma, Rituxan, Relapsed, Refractory
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UblituximabDrug
Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20)
| Study group | Role | What they receive |
|---|---|---|
| ublituximab | Experimental | Phase I:
4 cohorts with IV ublituximab starting with 450 mg followed by 600 mg, 900 mg or 1200 mg in each cohort (3 - 6 patients per cohort). Infusions will be on days 1, 8, 15 and 22 of cycle 1 followed by a planned maintenance with a single infusion monthly starting cycle 3. Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) will have infusions on Days 1, 8 and 15 of cycle 1 \& 2 followed by a planned maintenance with a single infusion monthly starting cycle 3. Expansion of patient enrollment in select cohorts will apply. Receives: Drug: Ublituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
Measured: Subjects will be followed for 4 weeks
Maximum Tolerated Dose acceptable for participants
The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board
Measured: Subjects will be followed for 4 weeks
Secondary outcomes (1)
Efficacy
Efficacy will include overall response rate, duration of response and progression-free survival
Measured: Participants will be evaluated approximately every 8 - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study start19 Jul 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkins 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- TG Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TG Therapeutics Clinical Trials, Study director, TG Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647971
- Sponsor's protocol ID
- TGTX 1101-101
- Status last verified
- Nov 2022
- First submitted
- 17 Jul 2012
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase I/II Study of the Efficacy and Safety of Ublituximab in Patients With B-cell Non-Hodgkin Lymphoma Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy
- ClinicalTrials.gov ID
- NCT01647971
- Acronym / sponsor ID
- TGTX 1101-101
- Conditions
- Non-Hodgkins Lymphoma, B-cell Lymphoma, Waldenstrom's Macroglobulinemia, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
- Keywords
- Lymphoma, Rituxan, Relapsed, Refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- TG Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2012 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Jul 2012 (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 determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ublituximab | Experimental | Drug: UblituximabPhase I: 4 cohorts with IV ublituximab starting with 450 mg followed by 600 mg, 900 mg or 1200 mg in each cohort (3 - 6 patients per cohort). Infusions will be on days 1, 8, 15 and 22 of cycle 1 followed by a planned maintenance with a single infusion monthly starting cycle 3. Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) will have infusions on Days 1, 8 and 15 of cycle 1 \& 2 followed by a planned maintenance with a single infusion monthly starting cycle 3. Expansion of patient enrollment in select cohorts will apply. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Relapsed or Refractory B-cell Lymphoma
- Measurable or Evaluable Disease
- Previously treated with at least one line of rituximab or a rituximab based therapy
- Patients ineligible for high dose or combination chemotherapy + stem cell transplant
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
Key exclusion criteria (5 listed)
- Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry
- Prior autologous or allogeneic stem cell transplantation within 3 months of study entry
- History of severe hypersensitivity or anaphylaxis to prior rituximab
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, brain metastasis, or psychiatric illness that would limit compliance with study requirements
- Pregnant women
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 is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20) | Drug | ublituximab |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Subjects will be followed for 4 weeks
Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation
Maximum Tolerated Dose acceptable for participants
Time frame: Subjects will be followed for 4 weeks
The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board
1 secondary outcome
Efficacy
Time frame: Participants will be evaluated approximately every 8 - 12 weeks
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 21 Nov 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.
TG Therapeutics Clinical Trials study director
TG Therapeutics, Inc.
8 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 in people with Non-Hodgkins Lymphoma and B-cell Lymphoma, run by TG Therapeutics, Inc. at 8 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 6 inclusion and 5 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 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: Subjects will be followed for 4 weeks). The study lists 2 primary outcomes in all. 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 Nov 2022.