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Brief Title: A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML
Official Title: Phase 1, Open-label, Study of Voruciclib in Subjects With Relapsed and/or Refractory B Cell Malignancies or AML After Failure of Prior Standard Therapies and Voruciclib in Combination With Venetoclax in Subjects With Relapsed/Refractory AML
Study ID: NCT03547115
Brief Summary: This is a Phase 1, open-label, dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML
Detailed Description: This is a Phase 1, open-label, 3 + 3 dose escalation and expansion study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of prior standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML. Escalation to the next higher dose level will depend on demonstrated safety and tolerability at each dose level.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
New York University, New York, New York, United States
Duke University, Durham, North Carolina, United States
Oregon Health and Science University, Portland, Oregon, United States
MD Anderson, Houston, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States