CSL362 for CD123+ Acute Myeloid Leukemia Currently in Remission
A Phase 1 Study of CSL362 (Anti-IL3Ra / Anti-CD123 Monoclonal Antibody) in Patients with CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission with Incomplete Platelet Recovery at High Risk for Early Relapse
|Closed||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.
Eligibility Criteria (must meet the following to participate in this study)
- 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).
Exclusions (conditions that would prevent participation in this study)
- 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).
Last UpdatedAugust 25, 2015
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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