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

Trial Title: CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML

NCT ID: NCT05558124

Condition: Acute Myeloid Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Daunorubicin
Gemtuzumab

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Vyxeos
Description: Fixed dose of Vyxeos (44 mg/m2 daunorubicin and 100 mg/m2 cytarabine) (Day 1, 3, and 5) in combination with various dose schedules of Gemtuzumab Ozogamicin (GO)
Arm group label: Dose Escalation

Other name: daunorubicin-cytarabine

Other name: CPX-351

Intervention type: Drug
Intervention name: Gemtuzumab Ozogamicin
Description: Participants will be treated at the following dose levels: Dose Level 1 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1 Dose Level 2 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1 and 4 Dose Level 3 - Gemtuzumab Ozogamicin will administered 3mg/m2 on Day 1, 4, 7
Arm group label: Dose Escalation

Other name: Mylotarg

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion 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 Exclusion Criteria: - 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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Moffitt Cancer Center

Address:
City: Tampa
Zip: 33612
Country: United States

Status: Recruiting

Contact:
Last name: Lisa Nardelli

Phone: 813-745-4731
Email: lisa.nardelli@moffitt.org

Contact backup:
Last name: Onyee Chan

Phone: 1-813-745-2069
Email: Onyee.Chan@moffitt.org

Investigator:
Last name: Onyee Chan, MD
Email: Principal Investigator

Start date: February 16, 2023

Completion date: November 2025

Lead sponsor:
Agency: H. Lee Moffitt Cancer Center and Research Institute
Agency class: Other

Collaborator:
Agency: Jazz Pharmaceuticals
Agency class: Industry

Source: H. Lee Moffitt Cancer Center and Research Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05558124
https://moffitt.org/clinical-trials-research/clinical-trials/?gclid=EAIaIQobChMImIymzIa-9gIVAZ2GCh3uzAWJEAAYASAAEgI0ovD_BwE