NCT05558124

CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML

A Phase 1/1b Dose Escalation and Expansion of CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety of combining the drugs gemtuzumab ozogamicin (GO) with CPX-351 in order to treat the disease, as well as to find the maximum tolerated dose level and recommended Phase 2 dose level of GO with a fixed dose of CPX-351.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Vyxeos	Fixed dose of Vyxeos (44 mg/m2 daunorubicin and 100 mg/m2 cytarabine) (Day 1, 3, and 5) in combination with various dose schedules of Gemtuzumab Ozogamicin (GO)
DRUG	Gemtuzumab Ozogamicin	Participants will be treated at the following dose levels: Dose Level 1 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1 Dose Level 2 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1 and 4 Dose Level 3 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1, 4, 7

Timeline

• Start date: 2023-02-16
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2022-09-28
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study