112
Participants
Start Date
December 29, 2021
Primary Completion Date
March 31, 2027
Study Completion Date
March 31, 2027
Tirabrutinib
Part A: Tirabrutinib 480 mg, taken orally, once a day on an empty stomach. Tirabrutinib treatment may be continued until disease progression or clinically unacceptable toxicity is observed.
Tirabrutinib
"Part B, Arm 1 - Tirabrutinib 320 mg or 480 mg, taken orally, once a day on an empty stomach in combination with an MTR induction regimen. Tirabrutinib with MTR treatment will be continued for 4 induction cycles (28-day/cycle), or until disease progression or clinically unacceptable toxicity is observed.~For patients not receiving consolidation treatment following induction, tirabrutinib 480 mg will be continued until disease progression, unacceptable toxicities are observed, or the Investigator decides to stop treatment."
Tirabrutinib
"Part B, Arm 2 - Tirabrutinib 320 mg or 480 mg, taken orally, once a day on an empty stomach in combination with an R-MPV induction regimen. Tirabrutinib with R-MPV treatment will be continued for 4 induction cycles (28-day/cycle), or until disease progression or clinically unacceptable toxicity is observed.~For patients not receiving consolidation treatment following induction, tirabrutinib 480 mg will be continued until disease progression, unacceptable toxicities are observed, or the Investigator decides to stop treatment."
RECRUITING
Memorial Sloan Kettering, New York
RECRUITING
Columbia University Irving Medical Center, New York
RECRUITING
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI)), Buffalo
RECRUITING
Hillman Cancer Center, University of Pittsburgh, Pittsburgh
RECRUITING
Penn State Hershey Cancer Center, Hershey
ACTIVE_NOT_RECRUITING
Abramson Cancer Center University of Pennsylvania, Philadelphia
RECRUITING
Georgetown University, Lombardi Comprehensive Cancer Center, Washington D.C.
RECRUITING
Duke University School of Medicine, Durham
WITHDRAWN
University of Tennessee Cancer Institute, Knoxville
RECRUITING
Levine Cancer Center, Charlotte
RECRUITING
Piedmont Healthcare, Atlanta
WITHDRAWN
Emory University - Winship Cancer Institute, Atlanta
ACTIVE_NOT_RECRUITING
Mayo Clinic- Jacksonville, Jacksonville
ACTIVE_NOT_RECRUITING
Orlando Health, Orlando
RECRUITING
Moffitt Cancer Center- Miami, Pembroke Pines
RECRUITING
University of Miami-Sylvester Cancer Center, Miami
RECRUITING
University of Alabama at Birmingham School of Medicine, Birmingham
RECRUITING
Vanderbilt-Ingram Cancer Center, Nashville
WITHDRAWN
Norton Cancer Institute - St. Matthews, Louisville
RECRUITING
University of Kentucky, Lexington
COMPLETED
University Of Michigan, Ann Arbor
RECRUITING
Cleveland Clinic, Cleveland
RECRUITING
Henry Ford Hospital, Detroit
WITHDRAWN
Mayo Clinic- Rochester, Rochester
ACTIVE_NOT_RECRUITING
The University of Kansas Cancer Center (KUCC) (Kansas City Cancer Center (KCCC)) - North, Kansas City
ACTIVE_NOT_RECRUITING
University of Nebraska Medical Center, Omaha
RECRUITING
Houston Methodist Research Institute (HMRI), Houston
RECRUITING
MD Anderson Cancer Center, Houston
RECRUITING
University of Colorado Denver, Aurora
RECRUITING
The University of Utah - Huntsman Cancer Institute (HCI), Salt Lake City
ACTIVE_NOT_RECRUITING
Mayo Clinic- Phoenix, Phoenix
WITHDRAWN
Cedar Sinai Medical Cancer, Hollywood
ACTIVE_NOT_RECRUITING
City of Hope Comprehensive Breast Cancer Center, Duarte
RECRUITING
University of California, Irvine, Irvine
ACTIVE_NOT_RECRUITING
Stanford University, Palo Alto
RECRUITING
Providence Health Cancer Center, Portland
RECRUITING
Seattle Cancer Care Alliance, Seattle
RECRUITING
Yale Cancer Center, New Haven
WITHDRAWN
Maine Medical Partners Neurology (Maine Neurology), Scarborough
ACTIVE_NOT_RECRUITING
Massachusetts General Hospital, Boston
ACTIVE_NOT_RECRUITING
Beth Israel Deaconess Medical Center, Boston
ACTIVE_NOT_RECRUITING
Dana-Farber Cancer Institute - Brigham & Women's Hospital, Boston
RECRUITING
Hackensack University Medical Center - John Theurer Cancer, Hackensack
RECRUITING
Lifespan Rhode Island Hospital, Providence
RECRUITING
The University of Vermont - Fletcher Allen Health Care, Burlington
Lead Sponsor
Ono Pharmaceutical Co. Ltd
INDUSTRY