MedDataX Logo

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

NCT ID: NCT02301156

Last Updated: 2022-05-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-27

Study Completion Date

2020-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia

NCT02612311

Chronic Lymphocytic Leukemia
TERMINATED PHASE3

Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

NCT04016805

Chronic Lymphocytic Leukemia
TERMINATED PHASE2

A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

NCT02264574

Chronic Lymphocytic Leukemia Small-Cell Lymphoma
COMPLETED PHASE3

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL

NCT01722487

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
COMPLETED PHASE3

A Phase II Study of Ibrutinib Plus FCR in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia

NCT02251548

Chronic Lymphocytic Leukemia Leukemia
ACTIVE_NOT_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Lymphocytic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Ublituximab

Intervention Type DRUG

Administered as an IV infusion

Ibrutinib

Intervention Type DRUG

Administered orally

Ibrutinib

Participants will receive ibrutinib 420 mg capsules, orally, QD in each 28-day cycle up to 62 months.

Group Type ACTIVE_COMPARATOR

Ibrutinib

Intervention Type DRUG

Administered orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ublituximab

Administered as an IV infusion

Intervention Type DRUG

Ibrutinib

Administered orally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TG-1101 IMBRUVICA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TG Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeff Sharman, MD

Role: STUDY_CHAIR

Willamette Valley Cancer Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

TG Therapeutics Investigational Trial Site

Huntsville, Alabama, United States

Site Status

TG Therapeutics Investigational Trial Site

Mobile, Alabama, United States

Site Status

TG Therapeutics Investigational Trial Site

Chandler, Arizona, United States

Site Status

TG Therapeutics Investigational Trial Site

Tucson, Arizona, United States

Site Status

TG Therapeutics Investigational Trial Site

Fayetteville, Arkansas, United States

Site Status

TG Therapeutics Investigational Trial Site

Jonesboro, Arkansas, United States

Site Status

TG Therapeutics Investigational Trial Site

Fullerton, California, United States

Site Status

TG Therapeutics Investigational Trial Site

Greenbrae, California, United States

Site Status

TG Therapeutics Investigational Trial Site

Los Angeles, California, United States

Site Status

TG Therapeutics Investigational Trial Site

Pismo Beach, California, United States

Site Status

TG Therapeutics Investigational Trial Site

Pleasanton, California, United States

Site Status

TG Therapeutics Investigational Trial Site

Santa Barbara, California, United States

Site Status

TG Therapeutics Investigational Trial Site

Aurora, Colorado, United States

Site Status

TG Therapeutics Investigational Trial Site

Bridgeport, Connecticut, United States

Site Status

TG Therapeutics Investigational Trial Site

Stamford, Connecticut, United States

Site Status

TG Therapeutics Investigational Trial Site

Newark, Delaware, United States

Site Status

TG Therapeutics Investigational Trial Site

Boca Raton, Florida, United States

Site Status

TG Therapeutics Investigational Trial Site

Fort Myers, Florida, United States

Site Status

TG Therapeutics Investigational Trial Site

Orange City, Florida, United States

Site Status

TG Therapeutics Investigational Trial Site

Pensacola, Florida, United States

Site Status

TG Therapeutics Investigational Trial Site

St. Petersburg, Florida, United States

Site Status

TG Therapeutics Investigational Trial Site

West Palm Beach, Florida, United States

Site Status

TG Therapeutics Investigational Trial Site

Albany, Georgia, United States

Site Status

TG Therapeutics Investigational Trial Site

Newnan, Georgia, United States

Site Status

TG Therapeutics Investigational Trial Site

Evanston, Illinois, United States

Site Status

TG Therapeutics Investigational Trial Site

Maywood, Illinois, United States

Site Status

TG Therapeutics Investigational Trial Site

Niles, Illinois, United States

Site Status

TG Therapeutics Investigational Trial Site

Urbana, Illinois, United States

Site Status

TG Therapeutics Investigational Trial Site

Fort Wayne, Indiana, United States

Site Status

TG Therapeutics Investigational Trial Site

Indianapolis, Indiana, United States

Site Status

TG Therapeutics Investigational Trial Site

Ames, Iowa, United States

Site Status

TG Therapeutics Investigational Trial Site

Cedar Rapids, Iowa, United States

Site Status

TG Therapeutics Investigational Trial Site

Westwood, Kansas, United States

Site Status

TG Therapeutics Investigational Trial Site

Baton Rouge, Louisiana, United States

Site Status

TG Therapeutics Investigational Trial Site

New Orleans, Louisiana, United States

Site Status

TG Therapeutics Investigational Trial Site

Baltimore, Maryland, United States

Site Status

TG Therapeutics Investigational Trial Site

Baltimore, Maryland, United States

Site Status

TG Therapeutics Investigational Trial Site

Bethesda, Maryland, United States

Site Status

TG Therapeutics Investigational Trial Site

Columbia, Maryland, United States

Site Status

TG Therapeutics Investigational Trial Site

Salisbury, Maryland, United States

Site Status

TG Therapeutics Investigational Trial Site

Boston, Massachusetts, United States

Site Status

TG Therapeutics Investigational Trial Site

Springfield, Massachusetts, United States

Site Status

TG Therapeutics Investigational Trial Site

Worcester, Massachusetts, United States

Site Status

TG Therapeutics Investigational Trial Site

Detroit, Michigan, United States

Site Status

TG Therapeutics Investigational Trial Site

Coon Rapids, Minnesota, United States

Site Status

TG Therapeutics Investigational Trial Site

Saint Louis Park, Minnesota, United States

Site Status

TG Therapeutics Investigational Trial Site

Lincoln, Nebraska, United States

Site Status

TG Therapeutics Investigational Trial Site

Omaha, Nebraska, United States

Site Status

TG Therapeutics Investigational Trial Site

Lebanon, New Hampshire, United States

Site Status

TG Therapeutics Investigational Trial Site

East Brunswick, New Jersey, United States

Site Status

TG Therapeutics Investigational Trial Site

Howell Township, New Jersey, United States

Site Status

TG Therapeutics Investigational Trial Site

Morristown, New Jersey, United States

Site Status

TG Therapeutics Investigational Trial Site

Pompton Plains, New Jersey, United States

Site Status

TG Therapeutics Investigational Trial Site

Somerville, New Jersey, United States

Site Status

TG Therapeutics Investigational Trial Site

New York, New York, United States

Site Status

TG Therapeutics Investigational Trial Site

Syracuse, New York, United States

Site Status

TG Therapeutics Investigational Trial Site

Charlotte, North Carolina, United States

Site Status

TG Therapeutics Investigational Trial Site

Durham, North Carolina, United States

Site Status

TG Therapeutics Investigational Trial Site

Raleigh, North Carolina, United States

Site Status

TG Therapeutics Investigational Trial Site

Canton, Ohio, United States

Site Status

TG Therapeutics Investigational Trial Site

Cincinnati, Ohio, United States

Site Status

TG Therapeutics Investigational Trial Site

Cleveland, Ohio, United States

Site Status

TG Therapeutics Investigational Trial Site

Portland, Oregon, United States

Site Status

TG Therapeutics Investigational Trial Site

Portland, Oregon, United States

Site Status

TG Therapeutics Investigational Trial Site

Springfield, Oregon, United States

Site Status

TG Therapeutics Investigational Trial Site

Camp Hill, Pennsylvania, United States

Site Status

TG Therapeutics Investigational Trial Site

Philadelphia, Pennsylvania, United States

Site Status

TG Therapeutics Investigational Trial Site

Pawtucket, Rhode Island, United States

Site Status

TG Therapeutics Investigational Trial Site

Greenville, South Carolina, United States

Site Status

TG Therapeutics Investigational Trial Site

Greenville, South Carolina, United States

Site Status

TG Therapeutics Investigational Trial Site

Sioux Falls, South Dakota, United States

Site Status

TG Therapeutics Investigational Trial Site

Watertown, South Dakota, United States

Site Status

TG Therapeutics Investigational Trial Site

Memphis, Tennessee, United States

Site Status

TG Therapeutics Investigational Trial Site

Nashville, Tennessee, United States

Site Status

TG Therapeutics Investigational Trial Site

Austin, Texas, United States

Site Status

TG Therapeutics Investigational Trial Site

Dallas, Texas, United States

Site Status

TG Therapeutics Investigational Trial Site

Denton, Texas, United States

Site Status

TG Therapeutics Investigational Trial Site

Fort Sam Houston, Texas, United States

Site Status

TG Therapeutics Investigational Trial Site

San Antonio, Texas, United States

Site Status

TG Therapeutics Investigational Trial Site

Tyler, Texas, United States

Site Status

TG Therapeutics Investigational Trial Site

Webster, Texas, United States

Site Status

TG Therapeutics Investigational Trial Site

Ogden, Utah, United States

Site Status

TG Therapeutics Investigational Trial Site

Blacksburg, Virginia, United States

Site Status

TG Therapeutics Investigational Trial Site

Richmond, Virginia, United States

Site Status

TG Therapeutics Investigational Trial Site

Seattle, Washington, United States

Site Status

TG Therapeutics Investigational Trial Site

Spokane, Washington, United States

Site Status

TG Therapeutics Investigational Trial Site

Vancouver, Washington, United States

Site Status

TG Therapeutics Investigational Trial Site

Ashkelon, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Israel

References

Explore related publications, articles, or registry entries linked to this study.

Sharman JP, Brander DM, Mato AR, Ghosh N, Schuster SJ, Kambhampati S, Burke JM, Lansigan F, Schreeder MT, Lunin SD, Zweibach A, Shtivelband M, Travis PM, Chandler JC, Kolibaba KS, Sportelli P, Miskin HP, Weiss MS, Flinn IW. Ublituximab plus ibrutinib versus ibrutinib alone for patients with relapsed or refractory high-risk chronic lymphocytic leukaemia (GENUINE): a phase 3, multicentre, open-label, randomised trial. Lancet Haematol. 2021 Apr;8(4):e254-e266. doi: 10.1016/S2352-3026(20)30433-6. Epub 2021 Feb 22.

Reference Type DERIVED
PMID: 33631112 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UTX-IB-301

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)
NCT03207555 COMPLETED PHASE2
Ibrutinib, Fludarabine, and Pembrolizumab in High-Risk or Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT03204188 ACTIVE_NOT_RECRUITING PHASE2
Obinutuzumab With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.
NCT02611908 WITHDRAWN PHASE1
Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT02518555 ACTIVE_NOT_RECRUITING PHASE2
Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib
NCT02759016 COMPLETED PHASE1
Urelumab (CD137 mAb) With Rituximab for Relapsed, Refractory or High-risk Untreated Chronic Lymphocytic Leukemia (CLL) Patients
NCT02420938 WITHDRAWN PHASE2
A Time-Limited Approach to Treatment With Ibrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
NCT04694560 WITHDRAWN
ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)
NCT06378138 RECRUITING PHASE2/PHASE3
Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
NCT02129062 TERMINATED PHASE2
Ibrutinib in Previously Untreated Binet Stage a Chronic Lymphocytic Leukemia with Risk of Disease Progression
NCT02863718 COMPLETED PHASE3
A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL
NCT02514083 ACTIVE_NOT_RECRUITING PHASE2
Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
NCT04608318 ACTIVE_NOT_RECRUITING PHASE3
Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia
NCT03701282 ACTIVE_NOT_RECRUITING PHASE3
Fixed-duration Therapy With Ibrutinib and Obinutuzumab (GA-101) in Treatment-naïve Patients With CLL
NCT04908228 RECRUITING PHASE2
A Study of BNC105P Combined With Ibrutinib
NCT03454165 COMPLETED PHASE1
Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL
NCT03502876 COMPLETED
Study of Ibrutinib in Subjects With Acute Myeloid Leukemia
NCT02351037 TERMINATED PHASE2
Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia
NCT02879695 ACTIVE_NOT_RECRUITING PHASE1
A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia
NCT03734016 COMPLETED PHASE3
A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL
NCT02268851 COMPLETED PHASE1
Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL
NCT02758665 COMPLETED PHASE2
Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
NCT03739814 SUSPENDED PHASE2
Early Access Program (EAP) for Ibrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
NCT02437019 APPROVED_FOR_MARKETING
A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML
NCT00528333 COMPLETED PHASE2
Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
NCT05694312 RECRUITING PHASE2