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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2026
  • participants needed
    30
  • sponsor
    Weill Medical College of Cornell University
Updated on 26 January 2021

Summary

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.

Details
Condition Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment gemtuzumab ozogamicin, CPX-351
Clinical Study IdentifierNCT03878927
SponsorWeill Medical College of Cornell University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Ability to understand and voluntarily give informed consent
Age55 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/L 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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