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NCT03207256 Clinical Trial

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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
An Open Label Extension Trial of Ublituximab and/or Umbralisib (TGR-1202) in Combination With Other Novel Agents or as Single Agents in Subjects Currently Receiving Treatment on a TG Therapeutics Study.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03207256
Other study ID # UTX-TGR-501
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date August 9, 2017
Est. completion date June 24, 2022

Study information
Verified date July 2022
Source TG Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 51
Est. completion date June 24, 2022
Est. primary completion date May 25, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• TGR-1202
Oral Daily TGR-1202
• TGR-1202 + Ublituximab
Oral Daily TGR-1202 + Ublituximab IV Administration

Locations
Country Name City State
United States TG Therapeutics Investigational Trial Site Atlanta Georgia
United States TG Therapeutics Investigational Site Canton Ohio
United States TG Therapeutics Investigational Trial Site Cincinnati Ohio
United States TG Therapeutics Investigational Trial Site Coon Rapids Minnesota
United States TG Therapeutics Investigational Trial Site Denton Texas
United States TG Therapeutics Investigational Trial Site Duarte California
United States TG Therapeutics Investigational Trial Site Durham North Carolina
United States TG Therapeutics Investigational Trial Site Fayetteville Arkansas
United States TG Therapeutics Investigational Trial Site Fort Myers Florida
United States TG Therapeutics Investigational Trial Site Fort Wayne Indiana
United States TG Therapeutics Investigational Trial Site Huntsville Alabama
United States TG Therapeutics Investigational Trial Site Milwaukee Wisconsin
United States TG Therapeutics Investigational Trial Site Nashville Tennessee
United States TG Therapeutics Investigational Trial Site Omaha Nebraska
United States TG Therapeutics Investigational Trial Site San Antonio Texas
United States TG Therapeutics Investigational Trial Site Seattle Washington
United States TG Therapeutics Investigational Trial Site Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
TG Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) Evaluated at each planned visit through study completion, an average of 2 years
Secondary Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment Date of progression reported for each patient Evaluated at each planned visit through study completion, an average of 2 years
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