Clinical trial NCT02013128: Ublituximab + Ibrutinib in Select B-cell Malignancies
Official title: A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Lymphocytic Leukemia
Mantle Cell Lymphoma
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.


Eligibility criteria: Inclusion Criteria:

* Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed.
* Refractory to or relapsed after at least 1 prior treatment regimen
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Known hepatitis B virus, hepatitis C virus or HIV infection
* Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded.
* Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma

Primary outcomes:
measure: To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies
timeFrame: 28 days (1 cycle of therapy)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 1 year
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: Santa Barbara
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Boulder
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Niles
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Urbana
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Bethesda
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Morristown
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Portland
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Oregon
city: Springfield
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Oregon
city: Greenville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: South Carolina
city: Memphis
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Austin
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Dallas
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Tyler
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Blacksburg
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Virginia
city: Fairfax
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Virginia
city: Vancouver
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
Study officials:
affiliation: Willamette Valley Cancer Institute
name: Jeff Sharman, MD
role: STUDY_CHAIR
References: