CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2020-01-22
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies the best dose and how well liposomal cytarabine-daunorubicin CPX-351 (CPX-351) works in treating patients with newly diagnosed acute myeloid leukemia and who are at risk for not responding well to treatment. Liposomal cytarabine-daunorubicin CPX-351 combines two chemotherapy drugs that are known to help each other work better, and may work to stop the growth of cancer cells by blocking the cells from dividing.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Celator Pharmaceuticals; National Cancer Institute (NCI)
• Treatments: Cytarabine; Daunorubicin

Criteria

Inclusion Criteria:

• Ability to understand and voluntarily sign an informed consent form

• Pathological diagnosis of AML according to World Health Organization (WHO) criteria (with at least 20% blasts in the peripheral blood or bone marrow): newly diagnosed de novo AML; except for acute promyelocytic leukemia (APL); newly diagnosed secondary AML, defined as having a history of an antecedent hematologic disorder (myelodysplastic syndromes [MDS], myeloproliferative disease [MPD] or history of cytotoxic treatment for non-hematologic malignancy) or apparent de novo AML with MDS-associated karyotype

• Eastern Cooperative Oncology Group (ECOG) performance status 0-3

• Serum creatinine =< 2.0 mg/dL

• Serum total bilirubin =< 2.0 mg/dL

• Serum alanine aminotransferase < 3 times the upper limit of normal (ULN); Note: If elevated liver enzymes are related to disease alanine aminotransferase (ALT) should be < 5 times ULN

• To be considered at high risk for induction mortality patients must have 1 or 2 of the following risk factors (patients >= 60 must have at least 1 risk factor, patients < 60 must have at least 2 risk factors) present; at least one risk factor in every patient must be an AML-related factor:

• AML-related factors include:

• Antecedent hematologic disorder (AHD) (MDS, chronic myelomonocytic leukemia [CMML], or MPD) or history of exposure to cytotoxic chemotherapy [therapy-related (t)-AML]), or WHO-defined AML with MDS-related changes or apparent de novo AML with MDS-associated karyotype

• Unfavorable cytogenetics as defined by the European Leukemia Net

• Patient-related factors:

• Age >= 70

• ECOG performance status (PS) >= 2

• Co-morbidities:

• Serum creatinine > 1.3 g/dL

• Cardiac ejection fraction >= 50% by echocardiography or multi gated acquisition (MUGA) (when left ventricular ejection fraction [LVEF] expressed as a range, at least the upper limit should include 50%)

• Able to adhere to the study visit schedule and other protocol requirements

• All men and women must agree to practice effective contraception during the study period if not otherwise documented to be infertile

Exclusion Criteria:

• Patients with history of second malignancy are eligible if they have documentation of disease stability, off therapy, based on computed tomography (CT) scan or other measures for the 6 months prior to entry in core

• Any serious medical condition or psychiatric illness that would prevent the patient from providing informed consent

• Chemotherapy or other investigational anticancer therapeutic drugs in the two weeks prior to study entry; in the event of rapidly proliferative disease, however, the use of hydroxyurea is permitted up to 24 hours before study entry in core

• Evidence of active central nervous system (CNS) leukemia

• Pregnant or lactating women

• Uncontrolled infection; to be eligible, patients receiving treatment for an infection (antibiotic, antifungal or antiviral treatment) must be afebrile (< 38.3 degrees Celsius [C]) and without hemodynamic instability or dyspnea from pneumonia for > 48 hours (hrs) prior to the start of induction therapy

• Hypersensitivity to cytarabine, daunorubicin or liposomal products

• History of Wilson's disease or other copper-metabolism disorder