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

NCT02533115 | Unknown

• 1 other identifier: CLTR0314-401
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

VYXEOS

Interventions

CPX-351 DRUG

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.

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and voluntarily give informed consent
• Age 60- 75 years
• Pathological diagnosis of AML according to WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow)
• Confirmation of:
• Therapy related AML: t-AML must have a history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated disease
• AML with a history of myelodysplasia
• AML with a history of CMMoL
• De novo AML with karyotypic abnormalities characteristic of MDS per WHO (see table)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Laboratory values fulfilling the following:
• Serum creatinine \< 2.0 mg/dL
• Serum total bilirubin \< 2.0 mg/dL
• Serum alanine aminotransferase or aspartate aminotransferase \< 3 times the ULN Note: If elevated liver enzymes above the ULN are related to disease, higher levels of ALT and AST may be considered.
• Cardiac ejection fraction ≥ 50% by echocardiography or MUGA

You may not qualify if:

• Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
• Acute promyelocytic leukemia \[t(15;17)\] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of registration.
• Clinical evidence of active CNS leukemia
• Patients with active (uncontrolled, metastatic) second malignancies are excluded.
• In the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment.
• Any major surgery or radiation therapy within four weeks.
• Patients with prior cumulative anthracycline exposure of greater than 368 mg/mP2P daunorubicin (or equivalent).
• Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
• Patients with myocardial impairment of any cause (e.g. 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)
• Active or uncontrolled infection. Patients 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 hrs.
• Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have post treatment negative culture(s) to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values)
• Hypersensitivity to cytarabine, daunorubicin or liposomal products
• History of Wilson's disease or other copper-metabolism disorder

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (6)

UCLA Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

The University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Weill Cornell Medical College- NY Presbyterian Hospital

New York, New York, 10021, United States

Location

Related Publications (1)

• Roboz GJ, Larson ML, Rubenstein SE, Solomon SR, Schiller GJ, An Q, Chiarella M, Louie AC, Lin TL. Final safety and efficacy results from the CPX-351 early access program for older patients with high-risk or secondary acute myeloid leukemia. Leuk Lymphoma. 2020 May;61(5):1188-1194. doi: 10.1080/10428194.2020.1725503. Epub 2020 Feb 26.

  PMID: 32102577 DERIVED

MeSH Terms

Interventions

CPX-351

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 26, 2015
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (6)