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Brief Title: Phase IB/II of CPX-351 for Relapse Prevention in AML
Official Title: Phase IB/II of CPX-351 as Maintenance Therapy in AML Patients Ineligible for Bone Marrow Transplantation
Study ID: NCT04990102
Brief Summary: This is a phase IB/II study with a 3+3 dose de-escalation study design. Patients will continue maintenance treatment with CPX-351 for 6 cycles on D1 and D3, as long as patient remains in CR. The dose de-escalation will be one dose given on D1 only, every 28 days pending toxicity. The maximum tolerated dose will be used for the phase II expansion portion of the study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Name: Kimberley Doucette, MD
Affiliation: Georgetown University
Role: PRINCIPAL_INVESTIGATOR