Skip to main content

Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

Trial Status: Active

Unity NHL - A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib with or without Bendamustine and Umbralisib alone in Patients with Previously Treated Non-Hodgkin's Lymphoma

Inclusion Criteria

  • Diagnosis of Non-Hodgkin's Lymphoma including Follicular, Mantle Cell Lymphoma and Marginal Zone Lymphoma
  • Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant
  • MCL subjects with one or more lines of therapy including at least one BTK inhibitor (ibrutinib, acalabrutinib or zanibrutinib only)

Exclusion Criteria

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
  • Autologous hematologic stem cell transplant within 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
  • Prior therapy with a PI3K delta inhibitor

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Rosa Bishop
Phone: 310-267-5426
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL
Contact: Januario Enrique Castro
Phone: 858-822-5354

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Julio C. Chavez
Phone: 813-745-2069

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Overland Park
University of Kansas Cancer Center-Overland Park
Status: ACTIVE
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Nicole M. Glynn-Cunningham
Phone: 410-328-7996
Towson
UM Saint Joseph Medical Center
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

Missouri

Kansas City
University of Kansas Cancer Center - North
Status: ACTIVE
Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Status: ACTIVE

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: ACTIVE

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

New York

Bronx
Montefiore Medical Center-Einstein Campus
Status: COMPLETED
Buffalo
Roswell Park Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE
New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Marcella West Aguilar
Phone: 214-648-1479
Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

The purpose of this study is to evaluate the efficacy and safety of umbralisib monotherapy

and the umbralisib + ublituximab (U2) combination in aggressive and indolent lymphomas and to

also explore the U2 regimen in combination with bendamustine in the treatment of NHL (FL,

SLL, MZL, DLBCL and MCL).

Trial Phase Phase II/III

Trial Type Treatment

Lead Organization
TG Therapeutics Inc

  • Primary ID UTX-TGR-205
  • Secondary IDs NCI-2016-01433
  • Clinicaltrials.gov ID NCT02793583