← Back to Search

Anti-tumor antibiotic, Anti-metabolites

Ruxolitinib + CPX-351 for Acute Myeloid Leukemia

Phase 1 & 2

Recruiting

Led By Ronan T Swords

Research Sponsored by Uma Borate

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Participants eligible for this study have either MPN in accelerated phase (AP) or blast phase (BP), defined as:

Must not have

Isolated myeloid sarcoma (i.e., participants must have blood or marrow involvement with AML to enter the study)

Acute promyelocytic leukemia (French-American-British [FAB] M3 classification)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date of first documented response (alr-c) to date of documented relapse, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the combination of two drugs, ruxolitinib and CPX-351, to treat patients with a specific type of leukemia.

Who is the study for?

This trial is for patients with advanced myeloproliferative neoplasms, including those previously diagnosed with conditions like polycythemia vera or essential thrombocythemia. Participants must be able to perform daily activities (ECOG status 0-2), have a heart function within normal limits, and agree to use contraception. Exclusions include ongoing participation in another clinical trial, certain leukemia types, uncontrolled infections or illnesses, known drug hypersensitivity, and recent surgery.

What is being tested?

The study is testing the combination of Ruxolitinib (a drug that blocks enzymes needed for cancer cell growth) with CPX-351 (chemotherapy encapsulated in fat particles designed to better target cancer cells). The goal is to determine the best dose and effectiveness of this combination treatment for secondary acute myeloid leukemia compared to CPX-351 alone.

What are the potential side effects?

Potential side effects may include risks associated with chemotherapy such as nausea, fatigue, increased risk of infection due to low blood counts; organ inflammation from Ruxolitinib; allergic reactions; liver issues indicated by elevated bilirubin levels; and digestive disturbances.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

My condition is in the accelerated or blast phase.

Select...

My blood or bone marrow has 10% to 19% blast cells.

Select...

I was previously diagnosed with PV, ET, or PMF.

Select...

I am eligible for strong chemotherapy to start my cancer treatment.

Select...

My kidney function, measured by creatinine or filtration rate, is within the required range.

Select...

My blood levels of potassium, magnesium, and calcium are normal or can be normalized with supplements.

Exclusion Criteria

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

Select...

My leukemia affects my blood or bone marrow.

Select...

I have a specific type of leukemia (FAB M3).

Select...

My leukemia has spread to my brain or spinal cord.

Select...

I don't have lasting side effects from cancer treatment worse than mild.

Select...

I have a blood clotting disorder with active bleeding or signs of clotting.

Select...

My disease is quickly worsening, or my organs are too weak for treatment.

Select...

I am allergic to ruxolitinib, cytarabine, daunorubicin, or liposomal products.

Select...

I have a history of Wilson's disease or a similar copper metabolism disorder.

Select...

I have received a high dose of a specific chemotherapy drug.

Select...

I will stop taking blood thinners before starting the study drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of first documented response (alr-c) to date of documented relapse, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of first documented response (alr-c) to date of documented relapse, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of first documented response (alr-c) to date of documented relapse, 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

Dose limiting toxicity (DLT) (Phase I)

Proportion of participants that achieve at least an Acute Leukemia Response-Partial response (>= ALR-P, per 2012 myeloproliferative neoplasm - blast phase [MPN-BP] criteria) (Phase 2)

Secondary study objectives

Event-free survival (EFS)

Incidence of adverse events as assessed by CTCAE version 5.0

Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

+4 more

Other study objectives

Proportion of participants who have an MRD negative status

Proportion of participants who have an minimal residual disease (MRD) negative status