A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

Not Recruiting

Trial ID: NCT04075747


JZP025-101 is an open-label, multicenter, multi-arm, nonrandomized phase 1b master trial to determine the recommended phase 2 dose (RP2D) of CPX-351 when administered in combination with various targeted agents in previously untreated subjects with Acute Myeloid Leukemia (AML) who are fit to receive intensive chemotherapy (ICT). Subjects will be assigned to treatment arms based on results of AML mutation testing.

Official Title

V-FAST: A Phase 1b Master Trial to Investigate CPX-351 Combined With Various Targeted Agents in Subjects With Previously Untreated Acute Myeloid Leukemia

Stanford Investigator(s)

Gabriel Mannis
Gabriel Mannis

Associate Professor of Medicine (Hematology)


Inclusion Criteria:

   - Age ≥ 18 to ≤ 75 years at the time of informed consent.

   - Newly diagnosed AML according to World Health Organization (WHO) pathological criteria
   (with at least 20% blasts in the peripheral blood or bone marrow).

   - ECOG performance status of 0 to 2.

   - Laboratory values fulfilling the following:

      - Serum creatinine < 2.0 mg/dL.

      - Serum total bilirubin < 2.0 mg/dL. (For subjects with Gilbert's Syndrome and
      serum total bilirubin ≥ 2.0 mg/dL, the medical monitor should be contacted.)

      - Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3
      times the upper limit of normal (ULN). (Note: If elevated liver enzymes > ULN are
      related to disease, contact medical monitor to discuss.)

   - Cardiac ejection fraction ≥ 50% by echocardiography or multiple gated acquisition scan

   - Subjects with second malignancies in remission may be eligible if there is clinical
   evidence of disease stability for a period > 6 months off cytotoxic chemotherapy,
   documented by imaging, tumor marker studies, etc., at screening. Subjects maintained
   on long-term nonchemotherapy treatment (eg, hormonal therapy) are eligible.

Exclusion Criteria:

   - Acute promyelocytic leukemia [t(15;17)].

   - Subject has favorable risk cytogenetics ((t8;21), inv(16), t(16;16), or t15;17)
   karyotype abnormalities) as categorized by the National Comprehensive Cancer Network
   (NCCN) Guidelines Version 2.2014 for AML (NCCN 2014).

   - Clinical evidence of active central nervous system (CNS) leukemia.

   - Subjects with active (uncontrolled, metastatic) second malignancies.

   - Subjects who have received prior treatment intended for induction therapy of AML; only
   hydroxyurea is permitted for control of blood cell counts. (For example, a subject
   with myelodysplastic syndrome [MDS] who changes hypomethylating agent [HMA] dose and
   schedule after the diagnosis of AML is excluded. AML-type therapy, such as cytarabine
   alone [> 1g/m2/day] or cytarabine plus an anthracycline as well as prior HSCT are also
   excluded.) All-trans-retinoic acid (ATRA) used empirically is permitted.

   - Subjects receiving administration of any therapy for MDS (conventional or
   investigational) must be completed by 2 weeks prior to the first dose of study drug.
   In the event of rapidly proliferative disease, use of hydroxyurea is permitted until
   24 hours before the start of study treatment. Toxicities associated with prior MDS
   therapy must have recovered to Grade 1 or less prior to start of treatment.

   - Subjects with myocardial impairment of any cause (eg, 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).

   - Subjects with 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 hours.

   - Current evidence of invasive fungal infection (blood or tissue culture). Subjects with
   recent fungal infection must have a subsequent negative culture to be eligible.

   - Subjects with known human immunodeficiency virus (new testing not required) or
   evidence of active hepatitis B or C infection.

   - Subjects with known history of Wilson's disease or other known copper-metabolism

   - Subjects with other comorbidity that the investigator judges to be incompatible with
   conventional ICT, and / or the targeted agent.


drug: CPX-351

drug: Venetoclax

drug: Midostaurin

drug: Enasidenib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amishi Jobanputra

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