Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials

NCT ID: NCT03207256

Last Updated: 2022-07-21

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-09

Study Completion Date

2022-06-24

Brief Summary

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This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia.

Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia Non Hodgkin Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TGR-1202

Oral TGR-1202 Daily

Group Type EXPERIMENTAL

TGR-1202

Intervention Type DRUG

Oral Daily TGR-1202

TGR-1202 + Ublituximab

Oral TGR-1202 in combination with Ublituximab intravenous administration

Group Type EXPERIMENTAL

TGR-1202 + Ublituximab

Intervention Type DRUG

Oral Daily TGR-1202 + Ublituximab IV Administration

Interventions

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TGR-1202

Oral Daily TGR-1202

Intervention Type DRUG

TGR-1202 + Ublituximab

Oral Daily TGR-1202 + Ublituximab IV Administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol.
* Subjects must have completed at least 6 cycles of therapy on their current protocol.

Exclusion Criteria

* Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.
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

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

Fayetteville, Arkansas, United States

Site Status

TG Therapeutics Investigational Trial Site

Duarte, California, United States

Site Status

TG Therapeutics Investigational Trial Site

Fort Myers, Florida, United States

Site Status

TG Therapeutics Investigational Trial Site

Atlanta, Georgia, United States

Site Status

TG Therapeutics Investigational Trial Site

Fort Wayne, Indiana, United States

Site Status

TG Therapeutics Investigational Trial Site

Coon Rapids, Minnesota, United States

Site Status

TG Therapeutics Investigational Trial Site

Omaha, Nebraska, United States

Site Status

TG Therapeutics Investigational Trial Site

Durham, North Carolina, United States

Site Status

TG Therapeutics Investigational Site

Canton, Ohio, United States

Site Status

TG Therapeutics Investigational Trial Site

Cincinnati, Ohio, United States

Site Status

TG Therapeutics Investigational Trial Site

Nashville, Tennessee, United States

Site Status

TG Therapeutics Investigational Trial Site

Denton, Texas, United States

Site Status

TG Therapeutics Investigational Trial Site

San Antonio, Texas, United States

Site Status

TG Therapeutics Investigational Trial Site

Seattle, Washington, United States

Site Status

TG Therapeutics Investigational Trial Site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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UTX-TGR-501

Identifier Type: -

Identifier Source: org_study_id

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