Acute Myeloid Leukemia Clinical Trial
Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
Summary
To confirm the efficacy of CPX-351 compared to 7+3 as first line therapy in elderly patients (60-75 yrs) with high risk (secondary) Acute Myeloid Leukemia. The primary efficacy endpoint will be overall survival.
Eligibility Criteria
Inclusion Criteria:
Ability to understand and voluntarily give informed consent
Age 60-75 years at the time of diagnosis of AML
Pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow)
Confirmation of:
Therapy related AML: t-AML must have a documented history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated disease
AML with a history of myelodysplasia: MDSAML must have bone marrow documentation of prior MDS
AML with a history of CMMoL: CMMoLAML must have bone marrow documentation of prior CMMoL
De novo AML with karyotypic abnormalities characteristic of MDS: de novoAML must have cytogenetics with abnormalities per WHO.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Able to adhere to the study visit schedule and other protocol requirements
Laboratory values fulfilling the following:
Serum creatinine < 2.0 mg/dL
Serum total bilirubin < 2.0 mg/dL, patients with Gilbert's Syndrome should contact the medical monitor
Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN Note: If elevated liver enzymes, above the ULN, are related to disease; contact medical monitor to discuss.
Cardiac ejection fraction ≥ 50% by echocardiography or MUGA
Patients with second malignancies in remission may be eligible if there is clinical evidence of disease stability for a period of greater than 6 months off cytotoxic chemotherapy, documented by imaging, tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible.
Exclusion Criteria:
Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization.
Clinical evidence of active CNS leukemia
Patients with active (uncontrolled, metastatic) second malignancies are excluded.
Prior treatment intended for induction therapy of AML; only hydroxyurea is permitted for control of blood counts. For example, a patient with MDS that changes HMA dose and schedule after the diagnosis of AML is excluded. AML-type therapy, such as cytarabine alone (>1g/m2/day) or cytarabine plus an anthracycline as well as prior HSCT are also excluded.
Administration of any therapy for MDS (conventional or investigational) must be completed by 2 weeks prior to of the first dose of study drug; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment. Toxicities associated with prior MDS therapy must have recovered to grade 1 or less prior to start of treatment.
Any major surgery or radiation therapy within four weeks.
Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent).
Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV staging)
Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥72 hrs.
Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have a subsequent negative cultures to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values)
Hypersensitivity to cytarabine, daunorubicin or liposomal products
History of Wilson's disease or other copper-metabolism disorder
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 41 Locations for this study
Birmingham Alabama, 35294, United States
Los Angeles California, 90095, United States
San Diego California, 92037, United States
Stanford California, 94305, United States
New Haven Connecticut, 06510, United States
Gainesville Florida, 32611, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60208, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46237, United States
Kansas City Kansas, 66160, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Minneapolis Minnesota, 55455, United States
Columbia Missouri, 65211, United States
Saint Louis Missouri, 63110, United States
Lebanon New Hampshire, 03756, United States
Hackensack New Jersey, 07601, United States
Bronx New York, 10467, United States
Long Island City New York, , United States
New York New York, 10032, United States
New York New York, 10065, United States
Valhalla New York, 10595, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Portland Oregon, 97213, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15219, United States
Charleston South Carolina, 29425, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Milwaukee Wisconsin, 53226, United States
Edmonton Alberta, T6G 2, Canada
Vancouver British Columbia, V5Z 1, Canada
Toronto Ontario, M5G2M, Canada
Montreal Quebec, , Canada
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.