Actively Recruiting
CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-27
18
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
J
Jazz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged between 18 and 70 years with newly diagnosed AML as per ELN 2017 criteria
- Females of child-bearing potential must use effective contraception during and for 6 months after treatment and have a negative pregnancy test within 24 hours before starting treatment
- Males of reproductive potential must use condoms or other effective contraception methods
- Myeloblasts must express CD33 as shown by flow cytometry or immunohistochemistry
- ECOG performance status of 2 or less and eligibility for intensive chemotherapy
- Prior malignancy allowed if not requiring ongoing treatment, except active hormonal therapy
- Prior hypomethylating agents allowed if last dose was at least 14 days before study treatment
- Acceptable organ function
- Adequate cardiac function with ejection fraction of 50% or higher by MUGA or 2D echocardiogram
- Hydroxyurea allowed for cytoreduction until day 1 of study treatment
You will not qualify if you...
- Prior AML treatment other than hydroxyurea or leukapheresis
- Diagnosis of acute promyelocytic leukemia (APL)
- Known active central nervous system leukemia
- Severe liver disease such as cirrhosis, non-alcoholic steatohepatitis, or sclerosing cholangitis or Wilson's disease
- Active infection with hepatitis B or C virus
- Known allergy to CPX-351 components or gemtuzumab ozogamicin
- Prior anthracycline exposure plus planned on-study exposure exceeding 550 mg/m2 daunorubicin or equivalent, or over 400 mg/m2 if mediastinal radiation
- Hemodynamic instability requiring vasopressor support
- Treatment with another investigational drug within 14 days
- Uncontrolled cardiac disease including severe heart failure, unstable angina, recent myocardial infarction
- Any condition impairing ability to consent or comply with study procedures
- Substance abuse or severe uncontrolled medical, social, or psychiatric conditions interfering with study completion or evaluation
- Pregnancy or breastfeeding
- Known FLT3 ITD or FLT3 TKD mutation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
L
Lisa Nardelli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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