Spots Global Cancer Trial Database for Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
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Trial Identification
Brief Title: Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)
Official Title: Phase 1 Dose Finding Study of Belinostat Plus Cyclophosphamide/Vincristine/Doxorubicin/Prednisone (CHOP) Regimen (BelCHOP) for Treatment of Patients With Peripheral T-cell Lymphoma(PTCL)
Study ID: NCT01839097
Conditions
Study Description
Brief Summary: The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study.
Detailed Description: This is a Phase 1 dose finding study using the traditional escalation rule of 3+3 design to evaluate the Maximum Tolerated Dose (MTD) of belinostat when administered in combination with CHOP.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yale University, New Haven, Connecticut, United States
Northeast Georgia Cancer Care, LLC, Athens, Georgia, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Hematology - Oncology Associates of Northern NJ P.A, Morristown, New Jersey, United States
Columbia University Medical Center/Center for Lymphiod Malignancies, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Contact Details
Name: Mi Rim Choi, MD
Affiliation: Spectrum Pharmaceuticals, Inc
Role: STUDY_DIRECTOR
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