|Recruiting||Acute Myeloid Leukemia||Phase I||
This is a first in human, prospective, multicenter, nonrandomized, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of repeat doses of CSL362.
- Male or female aged 18 years or older.
- Previous diagnosis of CD123+ acute myeloid leukemia (AML), de novo or secondary.
- Completed and recovered from all planned induction and consolidation therapy according to the institution's standard of care, and achieved a complete remission (CR)/CR with incomplete platelet recovery (CRp); either first or second CR.
- Has factors conferring high risk of relapse.
- No plans for additional post-remission chemotherapy.
- Not currently a candidate for allogeneic hematopoietic stem cell transplant (HSCT).
- Diagnosis of acute promyelocytic leukemia (APL).
- Known leukemic involvement of the central nervous system.
- Life expectancy 4 months or less as estimated by the investigator.
- Concurrent treatment or planned treatment with other anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy).
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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