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 2

Terminated

• Conditions: Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma
• Interventions: Drug: TGR-1202; Drug: TGR-1202 + Ublituximab

• Registration Number: NCT03207256
• Lead Sponsor: TG Therapeutics, Inc.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Study Start: 2017-08-09
• Primary Completion: 2022-05-25
• Study Completion: 2022-06-24
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TGR-1202	TGR-1202	Oral TGR-1202 Daily
TGR-1202 + Ublituximab	TGR-1202 + Ublituximab	Oral TGR-1202 in combination with Ublituximab intravenous administration

Primary Outcome Measures

Name	Time	Method
Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities	Evaluated at each planned visit through study completion, an average of 2 years	Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment	Evaluated at each planned visit through study completion, an average of 2 years	Date of progression reported for each patient

Trial Locations

Locations (2)

TG Therapeutics Investigational Site; 🇺🇸 Canton, Ohio, United States

TG Therapeutics Investigational Trial Site; 🇺🇸 Milwaukee, Wisconsin, United States