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

NCT03878927

Last updated date
Study Location
Weill Cornell Medical College
New York, New York, 10021, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Myeloid Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
Brief Title  ICMJE CPX-351+GO in Subjects 55 Years Old, or Older, With AML
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • Drug: CPX-351
    CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio. The liposome membrane is composed of distearoylphosphatidylcholine, distearoylphosphatidylglycerol and cholesterol in a 7:2:1 molar ratio.
    Other Name: Vyxeos
  • Drug: Gemtuzumab Ozogamicin
    Gemtuzumab ozogamicin is a CD-33 directed antibody drug conjugated to calicheamicin. CD 33 is expressed on myeloid leukemic blast cells and on normal hematopoietic cells. The drug is approved for the treatment of newly diagnosed CD 33 positive AML in adults and the treatment of relapsed and refractory CD 33 positive AML in adults. The drug is available for injection 4.5 mg as a lyophilized cake or powder in a single use vial for reconstitution and dilution.
    Other Name: Mylotarg
Study Arms  ICMJE
  • Experimental: Cohort A

    CPX-351 : Daunorubicin 44mg/m^2 and cytarabine 100mg/m^2/day on Days 1,3 and 5 (90 minute IV infusion)

    Gemtuzumab ozogamicin: 3mg/m^2/day on Day 1 (2 hour IV infusion)

    Interventions:
    • Drug: CPX-351
    • Drug: Gemtuzumab Ozogamicin
  • Experimental: Cohort B

    CPX-351: Daunorubicin 44mg/m^2 and cytarabine 100mg/m^2 on Days 1, 3 and 5 (90 minute IV infusion)

    Gemtuzumab ozogamicin: 3mg/m^2 on Days 1, 4 (2 hour IV infusion)

    Intervention: Drug: CPX-351
  • Experimental: Cohort C

    CPX-351: Daunorubicin 44mg/m^2 and cytarabine 100mg/m^2 on Days 1, 3, and 5 (90 minute IV infusion)

    Gemtuzumab ozogamicin: 3mg/m^2 on Days 1, 4 and 7 (2 hour IV infusion)

    Interventions:
    • Drug: CPX-351
    • Drug: Gemtuzumab Ozogamicin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 25, 2026
Estimated Primary Completion Date August 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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/?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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03878927
Other Study ID Numbers  ICMJE 1801018937
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE
  • Jazz Pharmaceuticals
  • Pfizer
Investigators  ICMJE
Principal Investigator:Ellen K Ritchie, MDWeill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP