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: Closed to Accrual
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: CLOSED_TO_ACCRUAL
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Rosa Bishop
Phone: 310-267-5426
Email:
rbishop@mednet.ucla.edu
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
San Diego
UC San Diego Medical Center - Hillcrest
Status: CLOSED_TO_ACCRUAL
Contact: Januario Enrique Castro
Phone: 858-822-5354
Email:
cancercto@ucsd.edu
District of Columbia
Washington
MedStar Georgetown University Hospital
Status: CLOSED_TO_ACCRUAL
Florida
Jacksonville
Mayo Clinic in Florida
Status: COMPLETED
Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Julio C. Chavez
Phone: 813-745-2069
Email:
Julio.C.Chavez@moffitt.org
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
Email:
nglynn@umm.edu
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: CLOSED_TO_ACCRUAL
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: CLOSED_TO_ACCRUAL
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
Email:
SCCCCTRP@UTSouthwestern.edu
Houston
M D Anderson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Washington
Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: CLOSED_TO_ACCRUAL
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center
Status: CLOSED_TO_ACCRUAL
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