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

Phase 2TerminatedNCT03207256

TG Therapeutics, Inc.51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Lymphocytic Leukemia Non Hodgkin Lymphoma

Interventions

TGR-1202DRUG

Oral Daily TGR-1202

TGR-1202 + UblituximabDRUG

Oral Daily TGR-1202 + Ublituximab IV Administration

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (17)

TG Therapeutics Investigational Trial Site

Huntsville, Alabama, United States

TG Therapeutics Investigational Trial Site

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities

Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)

Time frame: Evaluated at each planned visit through study completion, an average of 2 years

Secondary Outcomes

Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment

Date of progression reported for each patient

Time frame: Evaluated at each planned visit through study completion, an average of 2 years

Data from ClinicalTrials.gov

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