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Brief Title: A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma
Official Title: A Phase 1/1b Dose-Escalation Trial Evaluating CPI-818, an Oral Interleukin-2-Inducible T-Cell Kinase Inhibitor, in Subjects With Relapsed/Refractory T-Cell Lymphoma
Study ID: NCT03952078
Brief Summary: This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.
Detailed Description: This is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug. This trial is composed of dose escalation and dose expansion cohorts.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University, Palo Alto, California, United States
University of Michigan, Ann Arbor, Michigan, United States
Washington University, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Ohio State University, Columbus, Ohio, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Liverpool Hospital, Liverpool, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Epworth Healthcare, Melbourne, Victoria, Australia
Beijing Friendship Hospital, Beijing, Beijing, China
Beijing Boren Hospital, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Shanghai East Hospital, Pudong, Shanghai, China
Henan Cancer Hospital, Henan, Zhengzhou, China
Seoul National University Hospital, Seoul, Gyeonggido, Korea, Republic of
Asan Medical Center, Seoul, Gyeonggido, Korea, Republic of
Samsung Medical Center, Seoul, Gyeonggido, Korea, Republic of
Seoul St. Mary's Hospital, Seoul, Gyeonggido, Korea, Republic of
Inje University Busan-Paik Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Gachon University, Incheon, , Korea, Republic of
Name: Suresh Mahabhashyam, MD, MPH
Affiliation: Corvus Pharmaceuticals
Role: STUDY_DIRECTOR