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.

View Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

309

Study ID:

NCT01696084

Recruitment Status:

Completed

Sponsor:

Jazz Pharmaceuticals

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There are 41 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
UCLA
Los Angeles California, 90095, United States
University of CA San Diego
San Diego California, 92037, United States
Stanford University
Stanford California, 94305, United States
Yale University
New Haven Connecticut, 06510, United States
University of Florida
Gainesville Florida, 32611, United States
H. Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Northwestern University
Chicago Illinois, 60208, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
University of Chicago
Chicago Illinois, 60637, United States
Franciscan St. Francis Health
Indianapolis Indiana, 46237, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
University of Missouri
Columbia Missouri, 65211, United States
Washington University
Saint Louis Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Montefiore Medical Center
Bronx New York, 10467, United States
North Shore LIJ Health System
Long Island City New York, , United States
Columbia University
New York New York, 10032, United States
Cornell U, Weill Medical College
New York New York, 10065, United States
New York Medical College
Valhalla New York, 10595, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wake Forest University Health Services
Winston-Salem North Carolina, 27157, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
UPMC
Pittsburgh Pennsylvania, 15219, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Vanderbilt University
Nashville Tennessee, 37232, United States
Baylor Research Insitute
Dallas Texas, 75246, United States
M.D. Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada
British Columbia Cancer Center
Vancouver British Columbia, V5Z 1, Canada
Princess Margaret Hospital
Toronto Ontario, M5G2M, Canada
Hopital Maisonneuve-Rosemont
Montreal Quebec, , Canada

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

309

Study ID:

NCT01696084

Recruitment Status:

Completed

Sponsor:


Jazz Pharmaceuticals

How clear is this clinincal trial information?

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