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

CSL Limited

Status and phase

Completed

Phase 1

Conditions

Leukemia, Myeloid, Acute

Treatments

Biological: CSL362

Study type

Interventional

Funder types

Industry

Identifiers

NCT01632852

CSLCT-AML-11-73

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).