RECRUITING

CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to determine the safety of combining the drugs gemtuzumab ozogamicin (GO) with CPX-351 in order to treat the disease, as well as to find the maximum tolerated dose level and recommended Phase 2 dose level of GO with a fixed dose of CPX-351.

Official Title

A Phase 1/1b Dose Escalation and Expansion of CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed Acute Myeloid Leukemia

Quick Facts

Study Start:2023-02-16

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05558124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥18 and ≤70 years with newly diagnosed any risk AML as defined by ELN 2017 criteria * For females of child-bearing potential: use of highly effective contraception upon enrollment and during study participation and for an additional 6 months after the end of CPX-351 and Gemtuzumab ozogamicin administration: A female of child-bearing potential is considered when a sexually mature female: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months * The effects of CPX-351 and gemtuzumab ozogamicin on the developing human fetus are unknown. For this reason, women of child-bearing potential as defined above must have a negative serum or urine pregnancy test within 24 hours prior to beginning study treatment. * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner * Myeloblasts expressing CD33 as determined by flow cytometry or immunohistochemistry * ECOG ≤ 2 and eligible to receive intensive chemotherapy as determined by the treating physician * Prior malignancy is allowed providing it does not require concurrent therapy. Exception: Active hormonal therapy is allowed. * Prior hypomethylating agents (HMA) therapy including azacitidine or decitabine when used for non-AML diagnoses is allowed. Most recent dose must have been ≥14 days prior to day 1 of study treatment. * Participants must have acceptable organ function * Adequate cardiac function defined as ejection fraction of ≥50% as determined by multigated acquisition scan (MUGA) or 2D echocardiogram. * Hydroxyurea is allowed for cytoreduction until day 1 of study treatment	* Prior treatment of AML except hydroxyurea and/or leukapheresis * Participants with acute promyelocytic leukemia (APL). * Known current and clinically active central nervous system (CNS) leukemia. * Severe liver disease (cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis) or patients with known Wilson's disease. * Participants with known active infection with hepatitis B or hepatitis C virus * Known allergic reactions to components of the CPX-351 (cytarabine or daunorubicin) or Gemtuzumab ozogamicin. * Patients with any prior anthracycline exposure plus any planned on-study anthracycline exposure cannot not exceed 550 mg/m2 of daunorubicin (or equivalent). For participants who have received radiation therapy to the mediastinum, the total cumulative dose of anthracycline should not exceed 400 mg/m2 of daunorubicin(or equivalent). * Hemodynamically unstable (subjects requiring vasopressor support will not be eligible). * Treatment with another investigational drug within 14 days. * Uncontrolled cardiac disease including congestive heart failure class III or IV by the NYHA, unstable angina (angina symptoms at rest), new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months. * Any disorder that compromises the subject's ability to give written informed consent and/or to comply with study procedures. * Any substance abuse, severe and/or uncontrolled medical, social or psychiatric conditions that may prevent the subject from completing the study, interfere with the evaluation of safety and/or efficacy, or interfere with the interpretation of the study results. * Female subject who is pregnant or breastfeeding. * Any patient with a known FLT3 ITD or FLT3 TKD mutation

Inclusion Criteria

Exclusion Criteria

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥18 and ≤70 years with newly diagnosed any risk AML as defined by ELN 2017 criteria
* For females of child-bearing potential: use of highly effective contraception upon enrollment and during study participation and for an additional 6 months after the end of CPX-351 and Gemtuzumab ozogamicin administration: A female of child-bearing potential is considered when a sexually mature female: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months
* The effects of CPX-351 and gemtuzumab ozogamicin on the developing human fetus are unknown. For this reason, women of child-bearing potential as defined above must have a negative serum or urine pregnancy test within 24 hours prior to beginning study treatment.
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
* Myeloblasts expressing CD33 as determined by flow cytometry or immunohistochemistry
* ECOG ≤ 2 and eligible to receive intensive chemotherapy as determined by the treating physician
* Prior malignancy is allowed providing it does not require concurrent therapy. Exception: Active hormonal therapy is allowed.
* Prior hypomethylating agents (HMA) therapy including azacitidine or decitabine when used for non-AML diagnoses is allowed. Most recent dose must have been ≥14 days prior to day 1 of study treatment.
* Participants must have acceptable organ function
* Adequate cardiac function defined as ejection fraction of ≥50% as determined by multigated acquisition scan (MUGA) or 2D echocardiogram.
* Hydroxyurea is allowed for cytoreduction until day 1 of study treatment

* Prior treatment of AML except hydroxyurea and/or leukapheresis
* Participants with acute promyelocytic leukemia (APL).
* Known current and clinically active central nervous system (CNS) leukemia.
* Severe liver disease (cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis) or patients with known Wilson's disease.
* Participants with known active infection with hepatitis B or hepatitis C virus
* Known allergic reactions to components of the CPX-351 (cytarabine or daunorubicin) or Gemtuzumab ozogamicin.
* Patients with any prior anthracycline exposure plus any planned on-study anthracycline exposure cannot not exceed 550 mg/m2 of daunorubicin (or equivalent). For participants who have received radiation therapy to the mediastinum, the total cumulative dose of anthracycline should not exceed 400 mg/m2 of daunorubicin(or equivalent).
* Hemodynamically unstable (subjects requiring vasopressor support will not be eligible).
* Treatment with another investigational drug within 14 days.
* Uncontrolled cardiac disease including congestive heart failure class III or IV by the NYHA, unstable angina (angina symptoms at rest), new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
* Any disorder that compromises the subject's ability to give written informed consent and/or to comply with study procedures.
* Any substance abuse, severe and/or uncontrolled medical, social or psychiatric conditions that may prevent the subject from completing the study, interfere with the evaluation of safety and/or efficacy, or interfere with the interpretation of the study results.
* Female subject who is pregnant or breastfeeding.
* Any patient with a known FLT3 ITD or FLT3 TKD mutation

Contacts and Locations

Study Contact

Lisa Nardelli

CONTACT

1-813-745-4731

Lisa.Nardelli@moffitt.org

Principal Investigator

Onyee Chan, MD

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Onyee Chan, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-16

Study Completion Date2025-11

Study Record Updates

Study Start Date2023-02-16

Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

Acute Myeloid Leukemia