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

Phase 1

Completed

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Biological: CSL362

• Registration Number: NCT01632852
• Lead Sponsor: CSL Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-29
• Study First Submitted QC: 2012-06-29
• Study Start: 2012-07
• Study First Posted: 2012-07-03
• Primary Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-08
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CSL362	CSL362	See Intervention Description

Primary Outcome Measures

Name	Time	Method
Frequency and Severity of Adverse Events (AEs)	From the first treatment (Day 1) up to approximately Day 106	Number of subjects reporting any AEs and the severity of those AEs.
Dose-limiting toxicity (DLT) evaluation	From the first treatment (Day 1) up to approximately Day 106	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) Parameters	Before each infusion and: at 6 time points within a week after infusion 1, at 1 time point within a week after infusions 2 to 5, at 5 time points within a week after infusion 6, and once at the final visit, approximately 5 weeks after infusion 6	PK Parameters comprise: * Area under the serum concentration time curve (AUC) from time point zero (before dosing): * to the time point at which the analyte first returns to baseline (AUC0-last); * to a meaningful time after infusion (AUC0-y); * extrapolated to infinity (AUC0-∞).; * The maximum observed serum concentration (Cmax).; * First time to reach maximum concentration in serum (Tmax).; * Terminal serum half-life (t 1/2)
Number of subjects developing antibodies against CSL362	From the first treatment (Day 1) up to approximately Day 106

Trial Locations

Locations (5)

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

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States