NCT02533115

EAP of CPX-351 (VYXEOS) for Patients 60-75 Years of Age With Secondary AML

Expanded Access Protocol of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection for Patients 60-75 Years of Age With Secondary AML

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: —

Summary

This study is a Phase IV Expanded Access Protocol (EAP) of CPX-351 in patients with secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy.

Detailed description

The hypothesis that CPX-351 treatment may be safe and efficacious in patients with newly diagnosed secondary AML comes from a single randomized Phase II study which observed significant improvement in survival in a 52-patient subset of patients with secondary AML. A Phase III confirmatory study has recently completed accrual and final results are not expected until mid-2016. Therefore, the sponsor has chosen to make CPX-351 available to secondary AML patients through this expanded access protocol until commercialization of CPX-351 or more information about the clinical utility is known. This study is a Phase IV multicenter, single-arm open-label Expanded Access Protocol (EAP) of CPX-351 in patients with secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy. Patients may receive up to two inductions and four consolidation courses. Patients will be monitored for safety (early deaths, serious adverse events, grade 3 and 4 adverse events, etc.) while on the study and for SAEs for 30 days after the last dose of CPX-351. Study enrollment will be available through commercialization of CPX-351.

Conditions

• Secondary AML

Interventions

Type	Name	Description
DRUG	CPX-351	CPX-351 (cytarabine:daunorubicin) Liposome for Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio shown to act synergistically in pre-clinical studies. The liposome membrane is composed of distearoylphosphatidylcholine, distearoylphosphatidylglycerol and cholesterol in a 7:2:1 molar ratio. CPX-351 is provided as a sterile, pyrogen-free, purple, lyophilized product in 50 mL glass, single-use vials. Each 50 mL vial after reconstitution contains 20 mL of CPX-351 (5 units/mL). Each unit (u) contains 1 mg cytarabine and 0.44 mg daunorubicin base in liposomes suspended in sucrose. Product is stored at 5˚ ± 3PoPC.

Timeline

• First posted: 2015-08-26
• Last updated: 2017-08-22

Locations

6 sites across 1 country: United States