Vyxeos for Acute Myeloid Leukemia

Recruiting at 1 trial location

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ohio State University Comprehensive Cancer Center

Must be taking: Cytarabine, Daunorubicin

Must not be taking: Investigational agents

Disqualifiers: Acute promyelocytic leukemia, TP53 mutations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

28 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects and how well Vyxeos works in treating patients with intermediate and high-risk acute myeloid leukemia who have failed an initial cycle of standard cytarabine and daunorubicin chemotherapy. Vyxeos is a combination of both chemotherapy drugs cytarabine and daunorubicin contained in a liposome. Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cytarabine and daunorubicin given together in liposomes may have fewer side effects and work better than cytarabine and daunorubicin given alone in patients with acute myeloid leukemia.

Research Team

Gregory K Behbehani, MD, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Aspartate aminotransferase (AST) < 5 x upper limit of normal (ULN) for the local laboratory

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

My doctor thinks I won't fully recover without more treatment.

Exclusion Criteria

I am not pregnant, can use effective birth control for 6 months, and won't breastfeed for 14 days after my last Vyxeos dose.

Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Weekly visits

Long-term Follow-up

Participants are monitored monthly for progression-free survival and overall survival

Up to 2 years

Monthly visits

Treatment Details

Interventions

• Liposome-encapsulated Daunorubicin-Cytarabine

Trial Overview 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.

Participant Groups

Group I: Treatment (liposome-encapsulated daunorubicin-cytarabine) Experimental Treatment 1 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.

Liposome-encapsulated Daunorubicin-Cytarabine is already approved in United States for the following indications:

Approved in United States as Vyxeos for:

• Acute Myeloid Leukemia with myelodysplasia-related changes (AML-MRC)
• Therapy-related AML (t-AML)

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+