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Monoclonal Antibodies

Vyxeos + Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Onyee Chan, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Male or female, aged ≥18 and ≤70 years with newly diagnosed favorable or intermediate risk AML as defined by ELN 2017 criteria

Adequate cardiac function defined as ejection fraction of ≥50% as determined by multigated acquisition scan (MUGA) or 2D echocardiogram

Must not have

Patients with any prior anthracycline exposure plus any planned on-study anthracycline exposure cannot not exceed 550 mg/m2 of daunorubicin (or equivalent). For participants who have received radiation therapy to the mediastinum, the total cumulative dose of anthracycline should not exceed 400 mg/m2 of daunorubicin(or equivalent)

Participants with adverse risk AML as defined by ELN 2017 criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combining two drugs, to see if it is safe and effective.

Who is the study for?

Adults aged 18-70 with newly diagnosed AML that's not high-risk, who can undergo intensive chemo and have CD33-expressing myeloblasts. They must be willing to use effective contraception, have no severe liver disease or heart failure, and cannot be pregnant or breastfeeding. Prior treatment for non-AML conditions is okay if it was over two weeks ago.

What is being tested?

The trial tests combining Vyxeos (CPX-351) with Gemtuzumab Ozogamicin for treating AML. It aims to find the safest dose of GO when used with a fixed dose of CPX-351 and determine how well patients tolerate this combination therapy.

What are the potential side effects?

Potential side effects may include reactions related to infusion, impact on organ function including the heart and liver, blood disorders, increased risk of infections due to weakened immune system, fatigue, nausea, and potential harm to an unborn child.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 70 years old with a certain type of leukemia.

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My heart pumps well, with an ejection fraction of 50% or higher.

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My blood cancer cells test positive for CD33.

Exclusion Criteria

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

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My total anthracycline dose hasn't exceeded the limit, even with prior treatments.

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My AML is classified as high-risk according to ELN 2017.

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I have an active hepatitis B or C infection.

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I do not need medication to maintain my blood pressure.

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I have active leukemia in my brain or spinal cord.

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I do not have severe liver disease or Wilson's disease.

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I do not have severe heart problems like recent heart attacks or unstable chest pain.

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I am currently pregnant or breastfeeding.

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My cancer has a FLT3 mutation.

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I have received treatments for AML, but only hydroxyurea or leukapheresis.

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I am allergic to CPX-351 or Gemtuzumab ozogamicin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Maximum Tolerated Dose (MTD)

Secondary study objectives

Neoplasm, Residual

Overall Survival

Rate of Complete Remission

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment2 Interventions

Dose escalation to determine the maximum tolerated dose (MTD) of CPX-351 in combination with Gemtuzumab Ozogamicin in participants with newly diagnosed acute myeloid leukemia. Participants will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 3 dose levels will be used.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemtuzumab Ozogamicin

2006

Completed Phase 4

~460

0 / 14Eligibility criteria met