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RECRUITING
NCT04990102
PHASE1/PHASE2

Phase IB/II of CPX-351 for Relapse Prevention in AML

Sponsor: Georgetown University

View on ClinicalTrials.gov

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.

Official title: Phase IB/II of CPX-351 as Maintenance Therapy in AML Patients Ineligible for Bone Marrow Transplantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-05-22

Completion Date

2026-12

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

CPX-351

Daunorubicin 8.8mg/m2 + cytarabine 20mg/m2

Locations (3)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., 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