Treatment of secondary acute myeloid leukemia in patients under 60 with CPX-351
A Phase II Study of CPX-351 in Younger Patients < 60 Years Old With Secondary Acute Myeloid Leukemia
This study is testing a new treatment called CPX-351 to see if it can help younger patients with secondary acute myeloid leukemia feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Omaha, Nebraska and 3 other locations) |
| Trial ID | NCT04269213 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of liposome-encapsulated daunorubicin-cytarabine (CPX-351) in treating secondary acute myeloid leukemia (AML) in patients younger than 60 years old. The study aims to determine the complete response rate, duration of response, event-free survival, overall survival, and the rate of patients proceeding to allogenic hematopoietic cell transplant. Participants will receive CPX-351 intravenously over a series of days, with follow-up assessments conducted for up to five years post-treatment. The trial includes both induction and consolidation phases to maximize treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are patients under 60 years old with newly diagnosed secondary acute myeloid leukemia, including therapy-related AML and AML with myelodysplastic syndrome.
Not a fit: Patients with primary acute myeloid leukemia or those with significant comorbidities that affect treatment tolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve remission rates and overall survival for younger patients with secondary acute myeloid leukemia.
How similar studies have performed: Other studies have shown promise with similar chemotherapy approaches, but this specific combination in younger patients is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Prior treatment of AML * Known clinically active central nervous system (CNS) leukemia * Core-binding factor leukemia * Acute promyelocytic leukemia * Uncontrolled other malignancy * Prior anthracycline exposure \> 368 mg/m\^2 of daunorubicin or equivalent * 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 * Pregnant or breastfeeding women * 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 * 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
Where this trial is running
Omaha, Nebraska and 3 other locations
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
- SUNY Upstate Medical Center — Syracuse, New York, United States (Recruiting)
- Allegheny Health Network Cancer Institute - West Penn Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Steven Green, MD — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.