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Anti-tumor antibiotic

Vyxeos for Acute Myeloid Leukemia

Phase 1 & 2

Recruiting

Led By Gregory K Behbehani, MD, PhD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) functional status of 0, 1, or 2

Normal left ventricular ejection fraction (>= 50% by echocardiography or multi-gated acquisition radionuclide angiocardiography [MUGA]) and lifetime daunorubicin dose of less than 418 mg/m^2 (including recent course of 7+3)

Must not have

Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities

Total lifetime daunorubicin dose of more than 418 mg/m^2 (including recent course of 7+3) or equivalent total doses of other anthracycline medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This trial is testing Vyxeos, a combination of two chemotherapy drugs, to see if it is effective and has fewer side effects than the standard treatment for acute myeloid leukemia.

Who is the study for?

This trial is for adults with acute myeloid leukemia who didn't respond to initial chemo. They must be fit enough for intensive treatment, have proper heart function and organ health, and not exceed a lifetime dose of certain chemo drugs. Participants need to use effective contraception and cannot be pregnant or breastfeeding.

What is being tested?

The study tests Vyxeos, a liposome-encapsulated combo of chemotherapy drugs cytarabine and daunorubicin, in patients whose leukemia persisted after standard treatment. It aims to see if this approach has fewer side effects while being more effective.

What are the potential side effects?

Vyxeos may cause typical chemotherapy-related side effects such as fatigue, nausea, hair loss, increased risk of infection due to low blood cell counts, heart problems (rare), liver changes, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My heart pumps well and I've had limited exposure to a specific chemotherapy drug.

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My kidney function, measured by creatinine clearance or serum creatinine, is within the required range.

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I am a woman who can have children and agree to use two forms of birth control until 6 months after my last treatment dose. I also have a negative pregnancy test.

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I have been diagnosed with acute myeloid leukemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe heart conditions or recent heart attacks.

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I have received a high dose of daunorubicin or similar drugs.

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I have been diagnosed with acute promyelocytic leukemia.

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My AML is caused by a specific genetic change.

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My cancer has specific genetic changes related to TP53 or lacks p53 protein activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Calculation rate of complete response (CR) and complete response with incomplete hematologic recovery (CRi)

Incidence of adverse events

Secondary study objectives

Overall survival

Progression-free survival

Other study objectives

Efficacy of blast cell and leukemia stem/repopulating cell (LSC) elimination

Measurement of blast cell cycle fraction

Number of patients proceeding to stem cell transplantation following Vyxeos treatment

+1 more

Side effects data

From 2020 Phase 2 trial • 56 Patients • NCT02286726

25%

Febrile Neutropenia

21%

Neutropenic Fever

17%

Lung Infection

17%

Sepsis

13%

Insomnia

Pericardial Effusion

Infection

Hypertension

Pleural Effusion

Pancreatitis

Intracranial Hemorrhage

Cardiac Disorders

Fever

Joint Effusion

Alanine aminotransferase Increase

Anxiety

Blood Bilirubin Increase

Acute Coronary Syndrome

Respiratory Failure

Multi-Organ Failure

100%

80%

60%

40%

20%

Study treatment Arm

Arm II (Intermediate-dose (75 Units/m^2) CPX-351)

Arm III (Standard-dose (100 Units/m^2) CPX-351)

Arm I (Lower-dose (50 Units/m^2) CPX-351)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (liposome-encapsulated daunorubicin-cytarabine)Experimental Treatment1 Intervention

Within 14-33 days after the start of previous cycle of chemotherapy, patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daunorubicin

FDA approved

0 / 10Eligibility criteria met