Clinical trial · Interventional
A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission
A Phase 1 Study of CSL362 (Anti-IL3Rα / 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
NCT01632852CI-TRIAL-00019405completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CSL362 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CSL362
- description
- See Intervention Description
- interventionNames
- Biological: CSL362
Primary outcomes (2)
- measure
- Frequency and Severity of Adverse Events (AEs)
- timeFrame
- From the first treatment (Day 1) up to approximately Day 106
- description
- Number of subjects reporting any AEs and the severity of those AEs.
- measure
- Dose-limiting toxicity (DLT) evaluation
- timeFrame
- From the first treatment (Day 1) up to approximately Day 106
- description
- Number of participants with DLT. Dose-limiting toxicity (DLT) is defined as: * A non-hematological toxicity grade 3 or worse. * A hematological toxicity grade 3 that does not recover to baseline within 14 days. * A hematological toxicity grade 4 or worse according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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).
References
Publications (0)
Data not yet available
No reference posted for this study.