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

Leukemia, Myeloid, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632852
• Other study ID #: CSLCT-AML-11-73
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2012
• Last updated: October 8, 2015
• Start date: July 2012

Study information

• Verified date: October 2015
• Source: CSL Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• CSL362
CSL362 is humanized monoclonal antibody that targets the alpha chain of the interleukin 3 receptor (IL3Ra; also known as CD123) and is optimised for enhanced activation of antibody-dependent cell-mediated cytotoxicity (ADCC) via natural killer cells. CSL362 is a sterile solution for injection and will be administered by intravenous infusion to subjects in sequential, escalating dose level cohorts, at doses up to 12.0 mg/kg. CSL362 will be administered every 14 days for a total of 6 infusions per subject. The 6 infusions for each individual subject will contain the same dose of CSL362.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
CSL Limited	Parexel

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and Severity of Adverse Events (AEs)	Number of subjects reporting any AEs and the severity of those AEs.	From the first treatment (Day 1) up to approximately Day 106	Yes
Primary	Dose-limiting toxicity (DLT) evaluation	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.	From the first treatment (Day 1) up to approximately Day 106	Yes
Secondary	Pharmacokinetic (PK) Parameters	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 (AUC0-8).; The maximum observed serum concentration (Cmax).; First time to reach maximum concentration in serum (Tmax).; Terminal serum half-life (t 1/2)	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	No
Secondary	Number of subjects developing antibodies against CSL362		From the first treatment (Day 1) up to approximately Day 106	No