Clinical trial NCT03207256: 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
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Non Hodgkin Lymphoma
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities
timeFrame: Evaluated at each planned visit through study completion, an average of 2 years
Secondary outcomes:
measure: Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment
timeFrame: Evaluated at each planned visit through study completion, an average of 2 years
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Alabama
city: Tucson
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arizona
city: Fayetteville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arkansas
city: Duarte
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Fort Myers
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Atlanta
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Georgia
city: Fort Wayne
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Indiana
city: Coon Rapids
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Minnesota
city: Omaha
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Nebraska
city: Durham
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Canton
country: United States
facility: TG Therapeutics Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Nashville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Denton
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: San Antonio
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Seattle
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Milwaukee
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Wisconsin
Study officials:
References: