RecruitingPhase 2NCT03737955

Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia

A Phase 2 Trial of Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)


Sponsor

University of Washington

Enrollment

36 participants

Start Date

Nov 30, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies the how well fractionated gemtuzumab ozogamicin works in treating measurable residual disease in patients with acute myeloid leukemia. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a chemotherapy drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers a chemotherapy known as calicheamicin to kill them.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a drug called gemtuzumab ozogamicin (GO) to treat a very small amount of remaining leukemia — called measurable residual disease (MRD) — in patients with acute myeloid leukemia (AML) who are otherwise in remission. **You may be eligible if...** - You have been diagnosed with AML (a type of blood cancer) - You are technically in remission (less than 5% abnormal cells in bone marrow) but a very sensitive test still detects residual leukemia cells - Your leukemia has the CD33 protein marker on its surface - You are in generally good health with acceptable organ function - You are 18 years or older **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL) or mixed-cell leukemia - You have active, measurable leukemia (not just MRD) - You have had a prior severe reaction to GO - You have serious liver disease or other organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemtuzumab Ozogamicin

Receive IV

OTHERQuality-of-Life Assessment

Ancillary studies


Locations(1)

Fred Hutchinson Cancer Center/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT03737955


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