Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL) (GENUINE)

April 25, 2022 updated by: TG Therapeutics, Inc.

A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR [complete response] + PR [partial response]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashkelon, Israel
        • TG Therapeutics Investigational Trial Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • TG Therapeutics Investigational Trial Site
      • Mobile, Alabama, United States, 36604
        • TG Therapeutics Investigational Trial Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • TG Therapeutics Investigational Trial Site
      • Tucson, Arizona, United States, 85710
        • TG Therapeutics Investigational Trial Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • TG Therapeutics Investigational Trial Site
      • Jonesboro, Arkansas, United States, 72401
        • TG Therapeutics Investigational Trial Site
    • California
      • Fullerton, California, United States, 92835
        • TG Therapeutics Investigational Trial Site
      • Greenbrae, California, United States, 94904
        • TG Therapeutics Investigational Trial Site
      • Los Angeles, California, United States, 90045
        • TG Therapeutics Investigational Trial Site
      • Pismo Beach, California, United States, 93449
        • TG Therapeutics Investigational Trial Site
      • Pleasanton, California, United States, 94588
        • TG Therapeutics Investigational Trial Site
      • Santa Barbara, California, United States, 93105
        • TG Therapeutics Investigational Trial Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • TG Therapeutics Investigational Trial Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • TG Therapeutics Investigational Trial Site
      • Stamford, Connecticut, United States, 06904
        • TG Therapeutics Investigational Trial Site
    • Delaware
      • Newark, Delaware, United States, 19173
        • TG Therapeutics Investigational Trial Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • TG Therapeutics Investigational Trial Site
      • Fort Myers, Florida, United States, 33905
        • TG Therapeutics Investigational Trial Site
      • Orange City, Florida, United States, 32763
        • TG Therapeutics Investigational Trial Site
      • Pensacola, Florida, United States, 32504
        • TG Therapeutics Investigational Trial Site
      • Saint Petersburg, Florida, United States, 33709
        • TG Therapeutics Investigational Trial Site
      • West Palm Beach, Florida, United States, 33401
        • TG Therapeutics Investigational Trial Site
    • Georgia
      • Albany, Georgia, United States, 31701
        • TG Therapeutics Investigational Trial Site
      • Newnan, Georgia, United States, 30265
        • TG Therapeutics Investigational Trial Site
    • Illinois
      • Evanston, Illinois, United States, 60201
        • TG Therapeutics Investigational Trial Site
      • Maywood, Illinois, United States, 60153
        • TG Therapeutics Investigational Trial Site
      • Niles, Illinois, United States, 60714
        • TG Therapeutics Investigational Trial Site
      • Urbana, Illinois, United States, 61801
        • TG Therapeutics Investigational Trial Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • TG Therapeutics Investigational Trial Site
      • Indianapolis, Indiana, United States, 46237
        • TG Therapeutics Investigational Trial Site
    • Iowa
      • Ames, Iowa, United States, 50010
        • TG Therapeutics Investigational Trial Site
      • Cedar Rapids, Iowa, United States, 52403
        • TG Therapeutics Investigational Trial Site
    • Kansas
      • Westwood, Kansas, United States, 66205
        • TG Therapeutics Investigational Trial Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70816
        • TG Therapeutics Investigational Trial Site
      • New Orleans, Louisiana, United States, 70121
        • TG Therapeutics Investigational Trial Site
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • TG Therapeutics Investigational Trial Site
      • Baltimore, Maryland, United States, 21215
        • TG Therapeutics Investigational Trial Site
      • Bethesda, Maryland, United States, 20817
        • TG Therapeutics Investigational Trial Site
      • Columbia, Maryland, United States, 21044
        • TG Therapeutics Investigational Trial Site
      • Salisbury, Maryland, United States, 21801
        • TG Therapeutics Investigational Trial Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • TG Therapeutics Investigational Trial Site
      • Springfield, Massachusetts, United States, 01199
        • TG Therapeutics Investigational Trial Site
      • Worcester, Massachusetts, United States, 01608
        • TG Therapeutics Investigational Trial Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • TG Therapeutics Investigational Trial Site
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • TG Therapeutics Investigational Trial Site
      • Saint Louis Park, Minnesota, United States, 55416
        • TG Therapeutics Investigational Trial Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • TG Therapeutics Investigational Trial Site
      • Omaha, Nebraska, United States, 68130
        • TG Therapeutics Investigational Trial Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • TG Therapeutics Investigational Trial Site
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • TG Therapeutics Investigational Trial Site
      • Howell, New Jersey, United States, 07731
        • TG Therapeutics Investigational Trial Site
      • Morristown, New Jersey, United States, 07962
        • TG Therapeutics Investigational Trial Site
      • Pompton Plains, New Jersey, United States, 07444
        • TG Therapeutics Investigational Trial Site
      • Somerville, New Jersey, United States, 08876
        • TG Therapeutics Investigational Trial Site
    • New York
      • New York, New York, United States, 10019
        • TG Therapeutics Investigational Trial Site
      • Syracuse, New York, United States, 13210
        • TG Therapeutics Investigational Trial Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • TG Therapeutics Investigational Trial Site
      • Durham, North Carolina, United States, 27710
        • TG Therapeutics Investigational Trial Site
      • Raleigh, North Carolina, United States, 27607
        • TG Therapeutics Investigational Trial Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • TG Therapeutics Investigational Trial Site
      • Cincinnati, Ohio, United States, 45242
        • TG Therapeutics Investigational Trial Site
      • Cleveland, Ohio, United States, 44106
        • TG Therapeutics Investigational Trial Site
    • Oregon
      • Portland, Oregon, United States, 97227
        • TG Therapeutics Investigational Trial Site
      • Portland, Oregon, United States, 97213-2982
        • TG Therapeutics Investigational Trial Site
      • Springfield, Oregon, United States, 97477
        • TG Therapeutics Investigational Trial Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • TG Therapeutics Investigational Trial Site
      • Philadelphia, Pennsylvania, United States, 19104
        • TG Therapeutics Investigational Trial Site
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • TG Therapeutics Investigational Trial Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • TG Therapeutics Investigational Trial Site
      • Greenville, South Carolina, United States, 29607
        • TG Therapeutics Investigational Trial Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • TG Therapeutics Investigational Trial Site
      • Watertown, South Dakota, United States, 57201
        • TG Therapeutics Investigational Trial Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • TG Therapeutics Investigational Trial Site
      • Nashville, Tennessee, United States, 37203
        • TG Therapeutics Investigational Trial Site
    • Texas
      • Austin, Texas, United States, 78705
        • TG Therapeutics Investigational Trial Site
      • Dallas, Texas, United States, 75230
        • TG Therapeutics Investigational Trial Site
      • Denton, Texas, United States, 76201
        • TG Therapeutics Investigational Trial Site
      • Fort Sam Houston, Texas, United States, 78234
        • TG Therapeutics Investigational Trial Site
      • San Antonio, Texas, United States, 78229
        • TG Therapeutics Investigational Trial Site
      • Tyler, Texas, United States, 75702
        • TG Therapeutics Investigational Trial Site
      • Webster, Texas, United States, 77598-4420
        • TG Therapeutics Investigational Trial Site
    • Utah
      • Ogden, Utah, United States, 84403
        • TG Therapeutics Investigational Trial Site
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • TG Therapeutics Investigational Trial Site
      • Richmond, Virginia, United States, 23230
        • TG Therapeutics Investigational Trial Site
    • Washington
      • Seattle, Washington, United States, 98104
        • TG Therapeutics Investigational Trial Site
      • Spokane, Washington, United States, 99216
        • TG Therapeutics Investigational Trial Site
      • Vancouver, Washington, United States, 98683
        • TG Therapeutics Investigational Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
  • At least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection
  • Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
  • Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
  • Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ublituximab + Ibrutinib
Participants will receive ublituximab intravenous (IV) infusion, up to 150 milligrams (mg) once on Day 1, 750 mg on Day 2, 900 mg on Days 8 and 15 of Cycle 1 (Cycle duration=28 days) followed by 900 mg on Day 1 of Cycles 2 to 6 and 900 mg on Day 1 of every 3rd cycle thereafter for up to 62 months along with ibrutinib 420 mg capsules, orally, once daily (QD) in each 28-day cycle for up to 62 months.
Drug: Ibrutinib
Administered orally
Other Names:
  • IMBRUVICA
Drug: Ublituximab
Administered as an IV infusion
Other Names:
  • TG-1101
Active Comparator: Ibrutinib
Participants will receive ibrutinib 420 mg capsules, orally, QD in each 28-day cycle up to 62 months.
Drug: Ibrutinib
Administered orally
Other Names:
  • IMBRUVICA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to 62 months
ORR: Percentage of participants with best overall response of partial response(PR) and complete response(CR). CR criteria: No evidence of new disease; Absolute lymphocyte count(ALC)<4x10^9/liter(L); Regression of all target nodal masses to ≤1.5 centimeters(cm) in longest diameter(LD); Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; Absolute neutrophil count(ANC)>1.5x10^9/L,platelets≥100x10^9/L,hemoglobin (Hgb)≥110 gram per liter(g/L). PR criteria: No evidence of new disease; Response in 2 of following if abnormal at baseline: ALC<4x10^9/L or >=50% decrease from baseline in sum of products(SPD) of target nodal lesions; splenomegaly; hepatomegaly;>=50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules; response in any 1:ANC>1.5x10^9/L,platelets>100x10^9/L,Hgb>110g/L or >=50% increase over baseline in any of these.
Up to 62 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Response (CR) Rate
Time Frame: Up to 62 months
The CR rate was defined as the percentage of participants who achieved CR. CR criteria: No evidence of new disease; ALC <4 x 10^9/L; Regression of all target nodal masses to normal size ≤1.5 cm in the LD; Normal spleen and liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; ANC >1.5 x 10^9/L, platelets ≥100 x 10^9/L, Hgb ≥110 g/L.
Up to 62 months
Minimum Residual Disease (MRD) Negativity Rate
Time Frame: Up to 62 months
MRD negativity rate was defined as the percentage of participants who were MRD negative post-baseline. If a participant was determined to be MRD negative by peripheral blood, a bone marrow aspirate was obtained to assess MRD in the bone marrow.
Up to 62 months
Progression-Free Survival (PFS)
Time Frame: From the randomization until the first documentation of PD or death whichever occurs first or up to 62 months
PFS was defined as the time from the date of randomization until the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first. PD requires at least one of the following: New nodes >1.5 cm in the LD and >1.0 in longest perpendicular diameter (LPD), new or recurrent hepatomegaly or splenomegaly, new or reappearance of an unequivocal extra-nodal lesion, ≥50% increase from the nadir in the sum of products of target lesions, ≥50% increase in the LD of an individual node or extra-nodal mass, splenic/hepatic enlargement of ≥50% from nadir, unequivocal increase in the size of non-target disease, transformation to a more aggressive histology, decrease in platelet count or Hgb, >50% decrease from the highest on-study platelet count, >20 g/L decrease from the highest on-study Hgb.
From the randomization until the first documentation of PD or death whichever occurs first or up to 62 months
Duration of Response (DOR)
Time Frame: From the first dose of study drug until the first documentation of PD or death whichever occurs first or up to 62 months
DOR:Interval from first documentation of CR/PR to first documentation of PD or death from any cause.CR:ALC<4x10^9/L;Regression to normal of target nodal masses,nodal non-target disease,and no detectable non-nodal,non-target disease;Normal spleen,liver size;Morphologically negative bone marrow,No lymphoid nodules;ANC>1.5x10^9/L,Platelets≥100x10^9/L,Hgb≥110 g/L.PR:Response in 2 or more:ALC<4x10^9/L,>=50% drop from baseline in ALC or SPD of target nodal lesions,Hepatosplenomegaly,>=50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules;Response in 1 or more:ANC>1.5x10^9/L,Platelets>100x10^9/L,Hgb>110 g/L or >=50% increase over baseline in any.PD:Response in 1 or more:new nodes,Hepatosplenomegaly,unequivocal extra-nodal lesion;≥50% increase from nadir in SPD of target lesions or LD of node/extra-nodal mass or Splenic/Hepatic size,Unequivocal increase in non-target disease,More aggressive histology;Drop of >50% in platelets/>20g/L in Hgb from highest on-study count.
From the first dose of study drug until the first documentation of PD or death whichever occurs first or up to 62 months
Time to Response (TTR)
Time Frame: From the randomization up to 62 months
TTR was defined as the interval from the randomization to the first documentation of CR or PR. CR criteria: No evidence of new disease; ALC <4 x 10^9/L; Regression of all target nodal masses to normal size ≤1.5 cm in the LD; Normal spleen and liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; ANC >1.5 x 10^9/L, platelets ≥100 x 10^9/L, Hgb ≥110 g/L. PR criteria: No evidence of new disease; Response in 2 of following when abnormal at baseline: ALC<4 x 10^9/L or >=50% decrease from baseline in SPD of target nodal lesions; splenomegaly; hepatomegaly; >=50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules; and Response in 1 of the following: ANC>1.5 x 10^9/L, platelets>100 x 10^9/L, Hgb>110 g/L or >=50% increase over baseline in any of these.
From the randomization up to 62 months
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
Time Frame: From the first dose up to 30 days after the last dose of study drug (up to 57.3 months)
An adverse event (AE) is 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.
From the first dose up to 30 days after the last dose of study drug (up to 57.3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TG Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jeff Sharman, MD, Willamette Valley Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UTX-IB-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

TG Therapeutics does not currently plan to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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