CPX-351+GO in Subjects 55 Years Old, or Older, With AML



Status:Not yet recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:55 - Any
Updated:3/20/2019
Start Date:March 25, 2019
End Date:March 25, 2026
Contact:Ellen K Ritchie, MD
Email:ritchie@med.cornell.edu
Phone:646-962-2700

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Phase I Trial, With an Expansion Cohort, of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Combination With Gemtuzumab in Subjects With Acute Myeloid Leukemia >55 Years of Age Who Have Not Been Treated With Intensive Chemotherapy

This is an open label study to assess the safety and efficacy of CPX-351 in combination with
gemtuzumab ozogamicin (GO) as first intensive therapy in older (age >55 years) subjects with
newly diagnosed AML who are eligible for intensive induction chemotherapy, or AML subjects
who previously failed low-intensity therapy but who would be eligible for high-intensity
chemotherapy, with companion cognitive function testing to determine whether this contributes
to outcome in these subjects. Subjects may have received prior AML treatment with
non-intensive regimens, e.g. hypomethylating agents, low-dose cytarabine, or lenalidomide or
a clinical trial drug in combination with hypomethylating agents or low-dose cytarabine, but
may not have received intensive AML treatment with anthracyclines and/or infusional
cytarabine prior to enrollment on this trial. Subjects may not have been treated with GO or
other antibody targeting CD 33 prior to enrollment on this trial. The cohort will include 30
subjects treated with the combination of CPX-351 and GO and is designed to establish the
safety and feasibility of the combination. These subjects will be assessed for efficacy and
safety. Quality of life will be assessed using the FACT-LEU in all subjects. Cognitive
function will be assessed using the Blessed Orientation-Memory-Concentration Test and the
Montreal Cognitive Assessment.


Inclusion Criteria:

- Ability to understand and voluntarily give informed consent

- Age≥55 years at the time of study treatment

- Pathological diagnosis of AML according to WHO criteria (with >20% blasts in the
peripheral blood or bone marrow) including:

- De novo AML with intermediate or adverse-risk karyotypes (including subjects with
karyotypic abnormalities characteristic of MDS), who may have received treatment
with low-dose cytarabine, hypomethylating agents, and/or non-intensive
chemotherapy-based clinical trial treatments

- Secondary AML: transformed from prior MDS or MPN, confirmed by bone marrow
documentation of prior antecedent hematologic disorder

- Therapy-related AML: t-AML, requires documented history of prior cytotoxic
therapy or ionizing radiotherapy for an unrelated disease

- Performance status >50% KPS, ECOG 0-2

- Laboratory values fulfilling the following:

- Peripheral blast count is less than 30,000/μL prior to administration of drug

- Serum creatinine < 2.5 mg/dL

- Serum total bilirubin < 2.5 mg/dL

- Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN

- Subjects with elevated liver enzymes and serum creatinine values secondary to AML
are eligible after discussion with PI

- Cardiac ejection fraction ≥ 50% by echocardiography, MUGA, or Cardiac MRI

- Negative pregnancy test for non-menopausal women ≥ 55 years old

- Subjects with history of second malignancies in remission may be eligible if there is
clinical evidence of disease stability off cytotoxic chemotherapy, documented by
imaging, tumor marker studies, etc., at screening. Subjects maintained on long-term
non-chemotherapy treatment, e.g., hormonal therapy, are eligible.

Exclusion Criteria:

- Acute promyelocytic leukemia [t(15;17)], AML with karyotype inversion 16 or t(8;21)

- Clinical or morphologic evidence of active CNS leukemia

- Prior intensive chemotherapy for AML with anthracycline/cytarabine-based regimens, GO
or other antibody targeting CD33 as a single agent and/ or prior HSCT. Subjects may
have been treated with commercially available or investigational hypomethylating
agents (e.g. decitabine, azacitidine, SGI-110), lenalidomide, or low-dose cytarabine
(not to exceed 20 mg/m2 daily for 14 days for ≤ 6 cycles) or on clinical trials with
combinations of low-intensity chemotherapy agents. No more than one agent or
combination of agents can be given for treatment of AML prior to enrollment onto this
protocol.

- Prior treatment including HMA, systemic chemotherapy, surgery, or radiation therapy
must have been completed at least 7 days before start of study treatment or after
discussion with PI. Treatment with investigational agents must have been completed at
least 14 days prior to study drug treatment. Hydroxyurea is permitted for control of
blood counts before the start of study treatment. Toxicities associated with prior
therapies must have recovered to grade 1 or less prior to start of study treatment.

- Subjects 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

- Subjects 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. Subjects 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.

- Subjects with current or recent evidence of invasive fungal infection (blood or tissue
culture); subjects 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

- History of prior bone marrow or solid organ transplantation
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