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OncoMatch/Clinical Trials/NCT03737955

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

Is NCT03737955 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Gemtuzumab Ozogamicin for acute myeloid leukemia.

Phase 2RecruitingUniversity of WashingtonNCT03737955Data as of May 2026

Treatment: Gemtuzumab OzogamicinThis 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: CD33 expression

Patient's AML blasts must have CD33 expression.

Performance status

ECOG 0–3(Limited self-care)

Prior therapy

Min 1 prior line

Must have received: cytotoxic chemotherapy — induction

Patients must have received at least 1 cycle of standard induction chemotherapy prior to enrollment on the study.

Cannot have received: chemotherapy

Exception: within 14 days prior to entering the study

Subjects who have had chemotherapy or radiation therapy within 14 days prior to entering the study.

Cannot have received: radiation therapy

Exception: within 14 days prior to entering the study

Subjects who have had chemotherapy or radiation therapy within 14 days prior to entering the study.

Cannot have received: investigational agent

Subjects may not be receiving other investigational agents.

Lab requirements

Kidney function

Serum creatinine <= 2.0 mg/dL

Liver function

Total bilirubin <= 2 x institutional upper limit of normal for age (unless known history of Gilbert's disease); AST and ALT < 2.5 x institutional upper limit of normal for age (unless thought to be related to resolving infectious complications)

Serum creatinine <= 2.0 mg/dL. Total bilirubin <= 2 x institutional upper limit of normal for age (unless known history of Gilbert's disease). AST and ALT < 2.5 x institutional upper limit of normal for age (unless thought to be related to resolving infectious complications).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Fred Hutchinson Cancer Center/University of Washington Cancer Consortium · Seattle, Washington

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