VYxeoS Liposomal Italian Observational Study iN the Real Practice (VYSION)

Jazz Pharmaceuticals

Status: Active, not recruiting

Conditions: Therapy-Related Acute Myeloid Leukemia; Acute Myeloid Leukemia With Myelodysplasia-Related Changes; Acute Myeloid Leukemia (AML)

Treatments: Drug: Vyxeos liposomal

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06143839

JZP351-501

Details and patient eligibility

About

The study is a prospective, single-arm, non-experimental, observational study in patients in Italy with Acute Myeloid Leukaemia (AML) with myelodysplastic-related changes or therapy related AML initiating treatment with JZP351 (Vyxeos liposomal) in their normal clinical practice.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients newly diagnosed with AML-MRC (Acute myeloid leukemia with myelodysplasia-related changes) or t-related AML (Therapy related Acute myeloid leukemia) following 2016 World Health Organization (WHO) classification.
• Age ≥ 18 years old.
• Patients considered eligible for intensive chemotherapy in the opinion of the treating physician.
• Patients who will initiate the treatment with commercially JZP351 treatment after the Informed Consent Form (ICF) signature. The decision to prescribe JZP351 treatment must have been made prior and regardless of the enrollment of the patient in the study.
• Cardiac ejection fraction ≥ 50% by echocardiography or MUGA (Multi-Gated Acquisition).

Exclusion criteria

• Prior treatment intended for induction therapy of AML (Acute Myeloid Leukemia).
• Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
• Clinical evidence of active CNS (Central Nervous System) leukemia.
• Patients with active (uncontrolled, metastatic) second malignancies.

Trial design

112 participants in 1 patient group

Acute Myeloid Leukemia (AML)

Description:

Participants with newly diagnosed AML-MRC (Acute myeloid leukemia with myelodysplasia-related changes) or t-related AML (Therapy related Acute myeloid leukemia) receiving Vyxeos liposomal as part of their standard of care treatment.

Treatment:

Drug: Vyxeos liposomal