NCT04269213CompletedPhase 2
CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old
A Phase II Study of CPX-351 in Younger Patients < 60 Years Old With Secondary Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine (CPX-351) works in treating patients with secondary acute myeloid leukemia who are younger than 60 years old. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 11 Feb 2020
- Start date
- 29 Jul 2021
- Primary completion date
- 27 May 2025
- Lead sponsor
- Roswell Park Cancer Institute
- NCT number
- NCT04269213
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 21
- From 29 Jul 2021 to the primary completion date, 27 May 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment of AML
- Prior anthracycline exposure \> 368 mg/m\^2 of daunorubicin or equivalent
- Subject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
Other illness
- Uncontrolled other malignancy
- Cardiovascular disease resulting in heart failure (New York Heart Association class III or IV), unstable angina (angina symptoms at rest), or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
- Hypersensitivity to cytarabine, daunorubicin, or liposomal drugs
- Known active HIV infection
- Known history of active hepatitis B or C infection
- Pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)
- Evidence of ongoing, uncontrolled systemic infection
- History of Wilson disease or other copper-handling disorders
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Other
- Known clinically active central nervous system (CNS) leukemia
- Core-binding factor leukemia
- Acute promyelocytic leukemia
- Pregnant or breastfeeding women
Who the study is looking for
- Newly diagnosed:
- Therapy-related acute myeloid leukemia (AML)
- AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
- AML with MDS-related changes (as per World Health Organization \[WHO\])
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
- Plasma creatinine =\< 1.5 x upper limit of normal (ULN)
- Total bilirubin \< 2.0 mg/dL
- Serum alanine aminotransferase and aspartate aminotransferase \< 3 x ULN
- Left ventricular ejection fraction by echocardiogram or multiple-gated acquisition \>= 50%
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and commit to two forms of birth control
- Men must use a latex condom during any sexual contact with women of childbearing potential
- Willing to adhere to protocol specific requirements
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Allegheny Health Network Cancer Institute - West Penn Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| SUNY Upstate Medical Center Coordinator of this site? Confirm its status | Syracuse | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.