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Brief Title: A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia
Official Title: V-FAST: A Phase 1b Master Trial to Investigate CPX-351 Combined With Various Targeted Agents in Subjects With Previously Untreated Acute Myeloid Leukemia
Study ID: NCT04075747
Brief Summary: JZP025-101 is an open-label, multicenter, multi-arm, nonrandomized phase 1b master trial to determine the recommended phase 2 dose (RP2D) of CPX-351 when administered in combination with various targeted agents in previously untreated subjects with Acute Myeloid Leukemia (AML) who are fit to receive intensive chemotherapy (ICT). Subjects will be assigned to treatment arms based on results of AML mutation testing.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
Stanford University School of Medicine- Standford Cancer Institute, Palo Alto, California, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
University of Kansas Cancer Center, Fairway, Kansas, United States
Johns Hopkins University, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Duke University, Durham, North Carolina, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States