Phase 2
Completed N=56
CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia
Source: ClinicalTrials.gov NCT02286726 ↗Enrolled (actual)
56
Serious AEs
66.1%
Results posted
Jan 2021
Primary outcomePrimary: Number of Participants With a Response — 3; 6; 7; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Response |
3; 6; 7; 0; 3; 0 | — |
| SECONDARY Number of Participants Who Experienced Dose-limiting Toxicity (DLT) |
5; 3; 3 | — |
Eligibility 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 = = 60 must have at least 1 risk factor, patients = 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 ( 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
Data sourced from ClinicalTrials.gov (NCT02286726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.