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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 (Jun 2026). This Phase 2 trial studies Gemtuzumab Ozogamicin for acute myeloid leukemia.

Phase 2RecruitingUniversity of WashingtonNCT03737955Data as of Jun 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

Treatments studied

Targeted therapy

Gemtuzumab Ozogamicin

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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Frequently asked questions

Is NCT03737955 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chemotherapy, radiation therapy, investigational agent disqualifies patients from enrollment.

Does this trial require CD33?

Yes, CD33 expression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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