Clinical Trial 21450

• Overview

  Study Title:

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

  Summary:

  The purpose of this 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

  Objective:

  1. To determine the safety of combining gemtuzumab ozogamicin (GO) with CPX-351 and to determine maximal tolerated dose (MTD)/Recommended phase 2 dose (RP2D) of gemtuzumab ozogamicin with fixed dose of CPX-351; 2. To determine the rate of complete remission (CR) plus CR with incomplete count recovery (CRi); 3. To determine the rate of measurable residual disease via RT-PCR for core binding factor leukemia as well as NPM1 mutated AML; 4. To determine overall survival; 5. To determine relapse free survival.

• Treatments

  Therapies:

  Chemotherapy (NOS); Therapy (NOS)

  Medications:

  Cytarabine (Cytosine Arabinoside); Daunomycin (daunorubicin); Gemtuzumab Ozogamicin (); Mylotarg (Gemtuzumab Ozogamicin); daunorubicin ()

• 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 & > 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 > 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

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