ACTIVE_NOT_RECRUITING

Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)

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Conditions

Refractory Primary Central Nervous System LymphomaPrimary CNS LymphomaBruton's Tyrosine Kinase Inhibitor, BTKi, tirabrutinib, ONO-4059, PROSPECT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naïve PCNSL (Part B)

Official Title

An Open-label Phase II Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Tirabrutinib in Patients With Primary Central Nervous System Lymphoma (PCNSL)

Quick Facts

Study Start:2021-12-29
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04947319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Project Leader
STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd

Study Locations (Sites)

University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, 35233
United States
Mayo Clinic- Phoenix
Phoenix, Arizona, 85054
United States
City of Hope Comprehensive Breast Cancer Center
Duarte, California, 91010
United States
University of California, Irvine
Irvine, California, 92868
United States
Stanford University
Palo Alto, California, 94304
United States
University of Colorado Denver
Aurora, Colorado, 80045
United States
Yale Cancer Center
New Haven, Connecticut, 06510
United States
Georgetown University, Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20037
United States
Mayo Clinic- Jacksonville
Jacksonville, Florida, 32224
United States
University of Miami-Sylvester Cancer Center
Miami, Florida, 33136
United States
Orlando Health
Orlando, Florida, 32806
United States
Moffitt Cancer Center- Miami
Pembroke Pines, Florida, 33028
United States
Piedmont Healthcare
Atlanta, Georgia, 30318
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute - Brigham & Women's Hospital
Boston, Massachusetts, 02215
United States
University Of Michigan
Ann Arbor, Michigan, 41809
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
The University of Kansas Cancer Center (KUCC) (Kansas City Cancer Center (KCCC)) - North
Kansas City, Missouri, 64154
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Hackensack University Medical Center - John Theurer Cancer
Hackensack, New Jersey, 07601
United States
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))
Buffalo, New York, 14263
United States
Memorial Sloan Kettering
New York, New York, 10022
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Levine Cancer Center
Charlotte, North Carolina, 28204
United States
Duke University School of Medicine
Durham, North Carolina, 27705
United States
Cleveland Clinic
Cleveland, Ohio, 44106
United States
Providence Health Cancer Center
Portland, Oregon, 97239
United States
Penn State Hershey Cancer Center
Hershey, Pennsylvania, 17033
United States
Abramson Cancer Center University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Hillman Cancer Center, University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
United States
Lifespan Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
United States
Houston Methodist Research Institute (HMRI)
Houston, Texas, 77030
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
The University of Utah - Huntsman Cancer Institute (HCI)
Salt Lake City, Utah, 84112
United States
The University of Vermont - Fletcher Allen Health Care
Burlington, Vermont, 05401
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Ono Pharmaceutical Co. Ltd

  • Project Leader, STUDY_DIRECTOR, Ono Pharmaceutical Co. Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-29
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2021-12-29
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Bruton's Tyrosine Kinase Inhibitor, BTKi, tirabrutinib, ONO-4059, PROSPECT

Additional Relevant MeSH Terms

  • Refractory Primary Central Nervous System Lymphoma
  • Primary CNS Lymphoma