RecruitingPhase 1NCT05558124

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

18 participants

Start Date

Feb 16, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of two drugs — CPX-351 (a liposomal chemotherapy) and gemtuzumab ozogamicin (a targeted antibody) — for adults newly diagnosed with acute myeloid leukemia (AML), a blood cancer. **You may be eligible if:** - You are between 18 and 70 years old - You have just been diagnosed with AML (any risk category) - Your leukemia cells express a protein called CD33 - You are willing to use effective contraception throughout the study - You have adequate organ function **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have received prior treatment for AML - Your cancer cells do not express CD33 - You have severe heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVyxeos

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)

DRUGGemtuzumab 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

Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT05558124

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