A Phase 2 Trial of Fractionated Gemtuzumab Ozogamicin to Eradicate Measurable Residual Disease in Acute Myeloid Leukemia Patients (GO for MRD)
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.
Detailed description
OUTLINE: Patients receive gemtuzumab ozogamicin intravenously (IV) on days 1, 4, 7. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Responders and non-responders, without significant adverse events during the first course, may receive a second course of gemtuzumab ozogamicin within 60 days after course 1. After completion of study treatment, patients are followed up for 6 months.
Arms & interventions
- DrugGemtuzumab Ozogamicin
Receive IV
- OtherQuality-of-Life Assessment
Ancillary studies
Outcome measures
Primary
Clinical response rate
Measured by clearance of measurable residual disease (MRD) with bone marrow evaluation after one or two cycles of therapy and compare responses (rate of eradication of MRD) based on CD33 single nucleotide polymorphism rs12459419 genotype.
Time frame: Up to 70 days
Secondary
Rate of sinusoidal obstructive syndrome (SOS)
Time frame: Up to 6 months
Rate of allogeneic hematopoietic cell transplantation (HCT)
Time frame: Up to 6 Months
Eligibility criteria
Study locations (1)
Fred Hutchinson Cancer Center/University of Washington Cancer Consortium
Seattle, Washington, 98109