Chronic Lymphocytic Leukemia Clinical Trial

Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma

Summary

This is a phase 2, open label study to assess umbralisib in combination with ublituximab in subjects with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).

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Full Description

The study will assess the safety and efficacy of umbralisib in combination with ublituximab in participants with treatment naïve FL and SLL. Ublituximab will be administered through Cycle 12, while umbralisib will be administered through Cycle 24. After this time, participants will be followed for progression free survival (PFS).

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Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of FL or SLL.
Measurable disease that requires treatment
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

Currently or previously received treatment for their lymphoma
Received wide field radiotherapy within 28 days or limited field radiation within 14 days of Cycle 1 Day 1
Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT03828448

Recruitment Status:

Terminated

Sponsor:

TG Therapeutics, Inc.

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There are 3 Locations for this study

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TG Therapeutics Investigational Trial Site
Fort Myers Florida, 33901, United States
TG Therapeutics Investigational Trial Site
Saint Petersburg Florida, 33705, United States
TG Therapeutics Investigational Trial Site
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

34

Study ID:

NCT03828448

Recruitment Status:

Terminated

Sponsor:


TG Therapeutics, Inc.

How clear is this clinincal trial information?

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