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

Completed · Phase 1

Conditions studied: Leukemia, Myeloid, Acute

In brief

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.

Key facts

Study ID

NCT01632852

Run by

CSL Limited

People needed

30

Starts

2012-07-01

Last updated by the study team

2015-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School — Chicago, Illinois, United States
• Sidney Kimmel Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Weill Cornell Medical College — New York, New York, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Royal Melbourne Hospital — Parkville, Victoria, Australia

Full record on ClinicalTrials.gov

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