Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome or High-Risk Myeloproliferative Neoplasm
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome
- Myeloproliferative Neoplasm
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 2 years and 125 years
- Gender
- Both males and females
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 o...
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.
Tracking Information
- NCT #
- NCT03737955
- Collaborators
- National Cancer Institute (NCI)
- Pfizer
- Investigators
- Principal Investigator: Mary-Elizabeth Percival Fred Hutch/University of Washington Cancer Consortium