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Acute Myeloid LeukemiaPhase 1V-FASTNCT04075747

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

A Phase 1 study testing CPX-351, Venetoclax and Midostaurin in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
CPX-351, Venetoclax and Midostaurin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
10 sitesUnited States
Study dates
2 Dec 2019to 12 Sep 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)
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  • 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 (MUGA).
  • 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.

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke University

    Durham, North Carolina, 27710

  • University of Kansas Cancer Center

    Fairway, Kansas, 66205

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68105

  • Stanford University School of Medicine- Standford Cancer Institute

    Palo Alto, California, 94305

Other trials in United States

About this study

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

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.

Being tested
CPX-351, Venetoclax, Midostaurin, Enasidenib
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPX-351Drug

    Also called Vyxeos, JZP351

    Up to 2 induction and 2 consolidation courses will be offered

  • VenetoclaxDrug

    Also called Venclexta

    Will be administered over specified duration during induction and consolidation courses

  • MidostaurinDrug

    Also called Rydapt

    Will be administered over specified duration during induction and consolidation courses

  • EnasidenibDrug

    Also called Idhifa

    Will be administered over specified duration during induction and consolidation courses

Study groups in NCT04075747
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Drug: CPX-351; Drug: Venetoclax
Arm BExperimentalNot described
Receives: Drug: CPX-351; Drug: Midostaurin
Arm CExperimentalNot described
Receives: Drug: CPX-351; Drug: Enasidenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the Recommended Phase 2 Dose (RP2D)

    The RP2D will be determined by the specified dose de-escalation/dose escalation algorithm.

    Measured: Up to 30 months

  2. Safety and Tolerability of CPX-351 and Targeted Agents: incidence of adverse events (AEs) and dose limiting toxicities (DLTs)

    The safety and tolerability of CPX-351 and targeted agents when given in combination, based on the incidence of adverse events (AEs) and dose limiting toxicities (DLTs)

    Measured: Up to 30 months

Secondary outcomes (3)

  1. Proportion of subjects who have achieved CR, CRi, CRh, CR + CRi, CR + CRh, and morphologic leukemia-free state (MLFS)

    After up to 2 inductions

    Measured: Up to 30 months

  2. Proportion of subjects who have achieved CR / CRi with MRD negative status

    After up to 2 inductions

    Measured: Up to 30 months

  3. Proportion of subjects who have achieved CR / CRh with MRD negative status

    After up to 2 inductions

    Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2019
  2. Study start2 Dec 2019
  3. Primary completion7 Feb 2022
  4. Study completion12 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04075747
Sponsor's protocol ID
JZP025-101
Acronym
V-FAST
Status last verified
Oct 2023
First submitted
29 Aug 2019
Last updated
16 Oct 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pullarkat VA, Levis M, McCloskey J, Mannis GN, Strickland SA, Fathi AT, Lin TL, Bhatt VR, Vanniyasingam T, Chakravarthy D, Lutska Y, Faderl S, Cheung RS, Erba HP. V-FAST: a phase 1b master trial to investigate CPX-351 combined with targeted agents in adults with newly diagnosed AML. Blood Neoplasia. 2025 Jun 3;2(4):100123. doi: 10.1016/j.bneo.2025.100123. eCollection 2025 Nov.

    PubMed 40932876

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CPX-351, Venetoclax and Midostaurin in people with Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the Recommended Phase 2 Dose (RP2D) (time frame: Up to 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04075747, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.

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