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

NCT02533115 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2017-08-22

No results posted yet for this study

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.

Conditions

  • Secondary AML

Interventions

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.

Sponsors & Collaborators

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02533115 on ClinicalTrials.gov