Expanded Access Program for CPX-351 (VYXEOS) in Patients Aged 60-75 with Secondary Acute Myeloid Leukemia (AML)

Sponsor: Jazz Pharmaceuticals

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02533115

Provider View

This study offers access to CPX-351, a treatment for secondary acute myeloid leukemia (AML), for patients aged 60-75 who are eligible for intensive chemotherapy. The trial aims to evaluate the safety and effectiveness of CPX-351 in these patients.

Patient Parameters

Program Overview

This study provides access to CPX-351, a treatment for secondary acute myeloid leukemia (AML), for patients aged 60-75 who are suitable for intensive chemotherapy. The study is designed to see if CPX-351 is safe and effective for these patients. It is based on earlier research that showed promising results in improving survival for patients with secondary AML. Participants can receive up to two initial treatment cycles and four follow-up cycles. The study will monitor participants for safety and any serious side effects during the treatment and for 30 days after the last dose. Enrollment will continue until CPX-351 becomes commercially available.

Description

This study is part of an Expanded Access Program (EAP) for CPX-351, a treatment for secondary acute myeloid leukemia (AML) in patients aged 60-75 who can undergo intensive chemotherapy. Previous research showed that CPX-351 might improve survival in patients with secondary AML. While a larger study is ongoing, this program allows patients to access CPX-351 until it becomes commercially available or more information is available.

Participants in this study will receive CPX-351 in a single-arm, open-label format, meaning all participants receive the same treatment and know what they are receiving. They may undergo up to two initial treatment cycles and four additional cycles to consolidate the treatment's effects. Throughout the study, participants will be closely monitored for safety, including any serious side effects or adverse events. Monitoring will continue for 30 days after the last dose of CPX-351. Enrollment will remain open until CPX-351 is commercially available.

Eligibility Criteria

Inclusion Criteria

  • Ability to understand and voluntarily give informed consent
  • Aged between 60 and 75 years
  • Diagnosed with acute myeloid leukemia (AML) with at least 20% abnormal cells in the blood or bone marrow
  • Have one of the following:
    • Therapy-related AML with a history of previous cancer treatment
    • AML with a history of myelodysplasia
    • AML with a history of chronic myelomonocytic leukemia (CMMoL)
    • Newly diagnosed AML with specific genetic changes
  • Good overall health with an ECOG performance status of 0-2
  • Meet specific laboratory test criteria:
    • Serum creatinine less than 2.0 mg/dL
    • Serum total bilirubin less than 2.0 mg/dL
    • Liver enzymes (ALT/AST) less than 3 times the upper limit of normal, unless related to disease
  • Heart function with an ejection fraction of 50% or higher

Exclusion Criteria

  • History of certain blood disorders, except for CMMoL
  • Specific types of leukemia with known genetic markers
  • Active leukemia in the central nervous system
  • Active, uncontrolled, or metastatic second cancers
  • Recent major surgery or radiation therapy within four weeks
  • Previous high exposure to anthracycline drugs
  • Serious medical conditions or psychiatric illnesses that prevent informed consent
  • Heart failure or significant heart disease
  • Active or uncontrolled infections
  • Current or recent invasive fungal infections
  • Known HIV or active hepatitis B or C infections
  • Allergies to study drugs or similar products
  • History of Wilson's disease or other copper metabolism disorders

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