MEGO Therapy for Acute Myeloid Leukemia

Overseen By Linda Fukas, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Robert Redner, MD

Must not be taking: Mitoxantrone, Etoposide, GO

Disqualifiers: APL, Relapsed leukemia, Hepatitis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is an open-label, single arm phase II study which will examine the efficacy and toxicity of the combination therapy of GO, mitoxantrone and etoposide in patients who did not respond to first line induction therapy.

Research Team

Redner Robert, MD

Principal Investigator

UPMC Hillman Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Alanine aminotransferase (ALT) ≤ 2.5 x upper normal limit

Total bilirubin ≤ 2 x upper normal limit

Aspartate aminotransferase (AST) ≤ 2.5 x upper normal limit

Exclusion Criteria

My acute leukemia has returned after treatment.

My leukemia shows two types of cells.

I have previously been treated with mitoxantrone, etoposide, or GO.

Treatment Details

Interventions

• Etoposide
• Gemtuzumab Ozogamicin
• Mitoxantrone

Trial Overview 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.

Participant Groups

Group I: mitoxantrone + etoposide + gemtuzumab ozogamicin Experimental Treatment 1 Intervention

10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6

Etoposide is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Etoposide for:

• Testicular cancer
• Small cell lung cancer
• Non-Hodgkin lymphoma
• Acute myeloid leukemia

Approved in European Union as Etoposide for:

• Testicular cancer
• Small cell lung cancer
• Non-Hodgkin lymphoma
• Acute myeloid leukemia

Approved in Canada as Etoposide for:

• Testicular cancer
• Small cell lung cancer
• Non-Hodgkin lymphoma
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

Robert Redner, MD

Lead Sponsor

Trials

2

Recruited

50+

Konstantinos Lontos

Lead Sponsor

Trials

1

Recruited

20+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University