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About
This phase 2 clinical trial studies how well CPX-351 (liposomal cytarabine-daunorubicin) works in treating patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Full description
PRIMARY OBJECTIVES:
Determine efficacy of CPX-351 by measuring the response rate as the sum of complete response (CR) and complete remission with incomplete count recovery (CRi) in older patients (age 60 and older) with: higher risk of myelodysplastic syndrome (MDS) who are refractory/relapsed after prior hypomethylating (HMA) therapy; subjects greater than 75 years old with higher risk MDS who are HMA relapsed/refractory who have progressed to acute myeloid leukemia (AML)); AML with refractory/relapsed disease after prior HMA therapy for AML.
SECONDARY OBJECTIVES:
OUTLINE:
Patients receive liposomal cytarabine-daunorubicin CPX-351 intravenously (IV) at a dose of 65 units/m2/day over 90 minutes on days 1, 3, and 5 of each induction cycle.
After completion of study treatment, patients are followed up for up to 1 year.
Enrollment
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Inclusion criteria
Ability to understand and voluntarily give informed consent
Age ≥ 60
Pathological diagnosis of AML (by WHO criteria) or higher risk MDS (includes int-2 and high risk MDS by IPSS) along with one of the following:
Life expectancy > 1 month
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Able to adhere to the study visit schedule and other protocol requirements
Laboratory values fulfilling the following:
Cardiac ejection fraction ≥ 45% by echocardiography (transthoracic echocardiography) or MUGA scan
Patients with second malignancies may be eligible at discretion of PI given acute life threatening nature of untreated AML or higher risk MDS. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are also eligible.
Exclusion criteria
Patients who have previously undergone allogeneic hematopoietic stem cell transplant will be excluded from this study
Patients who have previously had > 368 mg/m2 cumulative dose of daunorubicin or > 368 mg/m2 daunorubicin-equivalent anthracycline therapy (for example, from prior treatment of solid tumors). See appendix for anthracycline equivalence table.
Acute promyelocytic leukemia [t(15;17)]
Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
Patients who have had conventional intensive cytotoxic induction chemotherapy for treatment of specifically MDS or AML are excluded.
Patients who have not previously been treated with HMA therapy will be excluded
Clinical evidence of active CNS leukemia
Patients with evidence of uncontrolled current myocardial impairment (e.g. unstable ischemic heart disease, uncontrolled arrhythmia, symptomatic valvular dysfunction not controlled on medical therapy, uncontrolled hypertensive heart disease, and uncontrolled congestive heart failure)
Active and uncontrolled infection. Patients with an active infection receiving treatment and hemodynamically stable for 48 hours may be entered into the study
Known active uncontrolled HIV or hepatitis C infection
Known hypersensitivity to cytarabine, daunorubicin or liposomal products
Known history of Wilson's disease or other copper-related disorders
Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation
Laboratory abnormalities:
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11 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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