CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia (NCT02286726) | Clinical Trial Compass
CompletedPhase 2
CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia
United States56 participantsStarted 2015-05-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
What they're measuring
1
Number of Participants With a Response
Timeframe: Up to 8 weeks (after induction therapy)