Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:60 - 75
Updated:11/23/2017
Start Date:November 2012
End Date:December 2017

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Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age With Untreated High Risk (Secondary) AML

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.


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
We found this trial at
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Saint Louis, Missouri 63110
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1720 2nd Ave S
Birmingham, Alabama 35233
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Chapel Hill, North Carolina 27599
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5801 South Ellis Avenue
Chicago, Illinois 60637
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Gainesville, Florida 32610
(352) 392-3261
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Minneapolis, Minnesota 55455
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116th St and Broadway
New York, New York 10027
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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4805 Northeast Glisan Street
Portland, Oregon 97213
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Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
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500 S State St
Ann Arbor, Michigan 48109
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
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450 Brookline Ave
Boston, Massachusetts 2215
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171 Ashley Avenue
Charleston, South Carolina 29425
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303 East Superior Street
Chicago, Illinois 60611
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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Columbia, Missouri 65211
(573) 882-2121
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Dallas, Texas 75246
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2301 Erwin Rd
Durham, North Carolina 27710
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Edmonton, Alberta
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30 Prospect Ave
Hackensack, New Jersey 07601
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Houston, Texas 77030
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Indianapolis, Indiana 46237
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3901 Rainbow Blvd
Kansas City, Kansas 66160
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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6860 Austin Street
Long Island City, New York 11375
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Los Angeles, California 90095
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
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3322 West End Avenue
Nashville, Tennessee 37203
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2201 West End Ave
Nashville, Tennessee 37232
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New Haven, Connecticut 6520
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450 Serra Mall
Stanford, California 94305
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The Bronx, New York 10467
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Winston-Salem, North Carolina 27157
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