Ublituximab + Ibrutinib in Select B-cell Malignancies

NCT ID: NCT02013128

Last Updated: 2022-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-06

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.

Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia Mantle Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ublituximab + ibrutinib

Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose

Group Type EXPERIMENTAL

Ublituximab

Intervention Type DRUG

Ublituximab (IV infusion)

Ibrutinib

Intervention Type DRUG

Ibrutinib oral daily dose

Interventions

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Ublituximab

Ublituximab (IV infusion)

Intervention Type DRUG

Ibrutinib

Ibrutinib oral daily dose

Intervention Type DRUG

Other Intervention Names

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Ibrutinib (IMBRUVICA)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TG Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeff Sharman, MD

Role: STUDY_CHAIR

Willamette Valley Cancer Institute

Locations

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TG Therapeutics Investigational Trial Site

Huntsville, Alabama, United States

Site Status

TG Therapeutics Investigational Trial Site

Tucson, Arizona, United States

Site Status

TG Therapeutics Investigational Trial Site

Santa Barbara, California, United States

Site Status

TG Therapeutics Investigational Trial Site

Boulder, Colorado, 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

Bethesda, Maryland, United States

Site Status

TG Therapeutics Investigational Trial Site

Morristown, New Jersey, 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

Greenville, South Carolina, United States

Site Status

TG Therapeutics Investigational Trial Site

Memphis, 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

Tyler, Texas, United States

Site Status

TG Therapeutics Investigational Trial Site

Blacksburg, Virginia, United States

Site Status

TG Therapeutics Investigational Trial Site

Fairfax, Virginia, United States

Site Status

TG Therapeutics Investigational Trial Site

Vancouver, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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UTX-IB-104

Identifier Type: -

Identifier Source: org_study_id

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