Actively Recruiting
Phase IB/II Study of CPX-351 as Maintenance Therapy for AML Patients Ineligible for Bone Marrow Transplant
Led by Georgetown University · Updated on 2026-03-23
24
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
J
Jazz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating CPX-351 as a maintenance therapy for patients with acute myeloid leukemia (AML) who are in remission but ineligible for bone marrow transplantation. This phase IB/II study uses a 3+3 dose de-escalation design to find the maximum tolerated dose of CPX-351 given every 28 days. The goal is to prevent relapse in AML patients who have completed induction treatment and achieved remission. The study compares two dosing schedules: Dose Level 1 administers CPX-351 intravenously on Day 1 and Day 3 of a 28-day cycle for 6 cycles, while Dose Level -1 gives a reduced dose on Day 1 only of each cycle for 6 cycles. Participants will remain on maintenance treatment as long as they stay in complete remission. The maximum tolerated dose determined in the first phase will be used for the phase II expansion. Participants will undergo regular treatment cycles with clinical monitoring for adverse events and survival outcomes. Researchers will assess safety by tracking treatment-related side effects during the 6 treatment cycles. They will also measure overall survival, event-free survival, and relapse-free survival for up to one year after treatment ends. This study lasts throughout the treatment cycles and includes long-term follow-up to evaluate the therapy's impact.
CONDITIONS
Brief Title
Phase IB/II of CPX-351 for Relapse Prevention in AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years
- Diagnosed with acute myeloid leukemia in complete remission or complete remission with partial count recovery
- Received any induction treatment with standard consolidation or hypomethylating agent plus venetoclax for up to 6 cycles or no more than 12 cycles total
- Able to start therapy within 3 months of last documented remission
- Diagnosed with de novo or secondary AML, including AML with myelodysplasia-related changes, confirmed by histology
- Ineligible for allogeneic bone marrow transplant for any reason
- Cardiac ejection fraction of 50% or greater by echocardiography or MUGA scan
- Adequate liver function with AST or ALT less than or equal to 3 times upper limit of normal (ULN), bilirubin less than or equal to 3 x ULN unless due to specific conditions
- Adequate kidney function with estimated creatinine clearance of 30 ml/min or higher
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Female participants must be non-reproductive or have a negative pregnancy test at entry
- Agree to use effective birth control during therapy and for 6 months after last dose
You will not qualify if you...
- Prior allogeneic transplant
- Previous high cumulative anthracycline dose exceeding limits
- Diagnosis of acute promyelocytic leukemia [t(15;17)]
- Unable to provide informed consent due to medical or psychiatric conditions
- Uncontrolled myocardial impairment or significant heart disease
- History of Wilson's disease or copper-related disorders
- Allergic reactions to drugs similar to cytarabine, daunorubicin, or liposomal products
- History of other cancers unless treated and disease-free for 3 years or specific low-risk cancers
- Unresolved toxicities from prior cancer treatment except alopecia
- Known bleeding disorders like von Willebrand's disease or hemophilia
- Active hepatitis B or C infection
- Uncontrolled active systemic infection
- Life-threatening illnesses or organ dysfunction compromising safety
- Active significant cardiovascular disease or recent heart events
- Known central nervous system involvement by leukemia
- Severe skin reactions like Stevens-Johnson syndrome
- Pregnant or breastfeeding
- Unable or unwilling to participate in required study procedures
- Unable to understand study purpose and risks or provide informed consent
- Significant hepatic impairment classified as moderate or worse according to Child Pugh classification
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive CPX-351 through intravenous infusion on Day 1 and Day 3 of each 28-day cycle for up to 6 cycles, or on Day 1 of each 28-day cycle for 6 cycles depending on dose level.
6 treatment visits (in-person) over 6 cycles
Duration - 1 year after end of treatment
Participants are monitored for safety and survival outcomes for 1 year after the end of treatment.
Regular visits during follow-up period
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here