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A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission

Complete title: 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

Research Study Number       2616.00
    
Principal Investigator       Roland Walter, MD
    
Phase       I

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Research Study Description

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)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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).

Other eligibility criteria may apply.

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).

Other exclusion criteria may apply.



Research Study Number       2616.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Acute Myeloid Leukemia (AML); Hematologic Malignancies; Leukemia

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