Status:
COMPLETED
CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 fo...
Detailed Description
PRIMARY OBJECTIVE: I. To assess preliminary efficacy (as determined by the rate of complete response \[CR\] or CR with incomplete blood count recovery \[CRi\]) of two or three dose levels of CPX-351 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 4 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT02286726
Start Date
May 4 2015
End Date
January 22 2020
Last Update
April 29 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030