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Topoisomerase II inhibitors

MEGO Therapy for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Konstantinos Lontos, MD
Research Sponsored by Robert Redner, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: ≥18 and ≤75 years-old
Patients with newly diagnosed AML based on the World Health Organization classification who have persistent disease after their first course treatment with an anthracycline and cytarabine
Must not have
Patients with a diagnosis of Acute Promyelocytic Leukemia (APL) as defined by the World Health Organization
Relapsed acute leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to five years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination therapy for leukemia patients who didn't respond to initial treatment.

Who is the study for?
This trial is for adults aged 18-75 with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who didn't respond to initial therapy. They must have certain blood and organ function levels, not be pregnant, agree to use contraception, and can't have other active cancers or severe diseases.
What is being tested?
The study tests a combination of drugs: mitoxantrone, etoposide, and gemtuzumab ozogamicin (MEGO), in patients whose AML/MDS did not improve after first-line treatment. It's an open-label phase II trial focusing on the effectiveness and safety of this regimen.
What are the potential side effects?
Potential side effects may include heart problems due to mitoxantrone, hair loss and nausea from etoposide, and liver toxicity from gemtuzumab ozogamicin. There could also be general effects like fatigue, infection risk increase, bleeding complications.

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 75 years old.
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My AML did not respond to the first treatment with anthracycline and cytarabine.
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My leukemia cells show high CD33 levels.
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I can take care of myself and am up and about more than half of the day.
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My kidneys are functioning well enough to clear waste.
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I have MDS and my treatment with anthracycline and cytarabine didn't work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Acute Promyelocytic Leukemia.
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My acute leukemia has returned after treatment.
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I have another active cancer besides the one being treated.
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My leukemia shows two types of cells.
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I am not pregnant or breastfeeding.
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I have previously been treated with mitoxantrone, etoposide, or GO.
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I am receiving my first treatment for acute myeloid leukemia with CPX-351.
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I have a serious illness that is not under control.
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I have had a stem cell transplant from a donor.
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I have a severe infection that isn't getting better with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five 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
Complete Remission Rate
Secondary study objectives
Cytogenetic Status
Overall Survival (OS)
Percent of Blasts
+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: mitoxantrone + etoposide + gemtuzumab ozogamicinExperimental Treatment1 Intervention
10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,658 Previous Clinical Trials
17,877,267 Total Patients Enrolled
Robert Redner, MDLead Sponsor
1 Previous Clinical Trials
29 Total Patients Enrolled
Konstantinos LontosLead Sponsor
~2 spots leftby Nov 2025
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