Spots Global Cancer Trial Database for A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
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Trial Identification
Brief Title: A Study of Duvelisib in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Official Title: A Multi-Center, Phase 2, Open-label, Parallel Cohort Study of Efficacy and Safety of Duvelisib in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Study ID: NCT03372057
Conditions
Study Description
Brief Summary: This is a multi-center, parallel cohort, open-label, Phase 2 study of duvelisib, an oral dual inhibitor of PI3K-δ,γ, in patients with relapsed/refractory Peripheral T-cell Lymphoma (PTCL).
Detailed Description: The study has 2 phases, a Dose Optimization Phase and an Expansion Phase. In the Dose Optimization Phase, patients will be randomly assigned to 1 of 2 study cohorts, as follows: * Cohort 1: Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-patient basis to 50 mg and then 75 mg, based on the patient's response to and tolerance of therapy, in 28-day cycles. * Cohort 2: Duvelisib 75 mg PO BID, administered in 28-day cycles. A total of 20 patients will be enrolled in the Dose Optimization Phase, with 10 patients per cohort. Based on the safety and activity data obtained in the Dose Optimization Phase of the study, the Expansion Phase dose of Duvelisib will be determined. In the Expansion Phase, approximately 100-130 patients may be enrolled and will receive Duvelisib dose in 28-day cycles as determined in Dose Optimization Phase.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
University of California - Irvine, Irvine, California, United States
University of California - Los Angeles, Los Angeles, California, United States
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
Northwestern University - Feinberg School of Medicine, Chicago, Illinois, United States
Norton Cancer Institute, Louisville, Kentucky, United States
University of Maryland, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Washington University, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Stony Brook Cancer Center, Stony Brook, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Novant Health, Charlotte, North Carolina, United States
Duke University, Durham, North Carolina, United States
The Ohio State University, Columbia, Ohio, United States
Toledo Cancer Center, Toledo, Ohio, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Baylor Research Institute - Charles Sammons Cancer Center, Dallas, Texas, United States
Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV, Halle, Sachsen-Anhalt, Germany
Universitätsklinikum Carl Gustav Carus, Dresden, Sachsen, Germany
ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo, Bergamo, , Italy
A.O.di Bologna Policl.S.Orsola, Bologna, , Italy
Ieo, Irccs, Milano, , Italy
Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore, Roma, , Italy
Azienda Ospedaliera Santa Maria di Terni, Terni, , Italy
Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Contact Details
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