Actively Recruiting
Phase IB/II of CPX-351 for Relapse Prevention in AML
Led by Georgetown University · Updated on 2026-03-23
24
Participants Needed
3
Research Sites
184 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
J
Jazz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase IB/II of CPX-351 for Relapse Prevention in AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed patients over 18 years of age
- Patients must be in complete remission or complete remission with partial count recovery
- Must have received any induction treatment with standard consolidation or hypomethylating agent plus venetoclax, for up to 6 cycles or no more than 12 cycles of treatment
- Must be able to start therapy within 3 months of last documented remission
- Diagnosed with de novo or secondary AML, excluding acute promyelocytic leukemia, including AML with myelodysplasia-related changes
- Ineligible for allogeneic bone marrow transplant for any reason
- Cardiac ejection fraction of 50% or higher by echocardiography or MUGA scan
- Adequate liver function: AST or ALT less than or equal to 3 times the upper limit of normal, bilirubin less than or equal to 3 times upper limit of normal unless due to Gilbert's syndrome or non-hepatic causes
- Adequate kidney function with estimated creatinine clearance of 30 ml/min or higher
- Eastern Cooperative Oncology Group performance status of 3 or less
- Female subjects must be of non-reproductive potential or have a negative pregnancy test if of childbearing potential
- Male and female subjects agree to use highly effective birth control during treatment and for at least 6 months after last dose
You will not qualify if you...
- Prior allogeneic transplant
- Previous high cumulative anthracycline dose or prior mediastinal radiation exceeding specified limits
- Diagnosis of acute promyelocytic leukemia
- Unable to sign informed consent due to serious medical or psychiatric conditions
- Uncontrolled current heart conditions such as unstable ischemic heart disease or uncontrolled arrhythmia
- History of Wilson's disease or other copper-related disorders
- Allergic reactions to cytarabine, daunorubicin, or liposomal products
- History of other malignancies except those treated with curative intent and no active disease for 3 years or specified low-risk cancers
- Unresolved toxicities from prior cancer therapy above specified levels
- Known bleeding disorders or hemophilia
- Active infection with hepatitis B or C virus without negative PCR tests
- Any uncontrolled active systemic infection
- Life-threatening illness or medical condition risking safety or study results
- Active severe cardiovascular disease or recent heart events
- Known central nervous system leukemia involvement
- Severe skin conditions like Stevens-Johnson syndrome
- Pregnant or breastfeeding
- Unable or unwilling to participate fully in study evaluations
- Significant hepatic impairment (moderate or worse)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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