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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With a Response
Timeframe: Up to 8 weeks (after induction therapy)