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

Status:	Completed
Conditions:	Blood Cancer, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	July 2012

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

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.

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).

We found this trial at

sites

Weill-Cornell Medical College

New York, New York 10021

from

New York, NY