Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
CSL Limited Identifier:
First received: June 29, 2012
Last updated: October 8, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Leukemia, Myeloid, Acute
Biological: CSL362
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • Frequency and Severity of Adverse Events (AEs) [ Time Frame: 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 [ Time Frame: 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:
  • Pharmacokinetic (PK) Parameters [ Time Frame: 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 [ Time Frame: From the first treatment (Day 1) up to approximately Day 106 ]

Enrollment: 30
Study Start Date: July 2012
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CSL362
See Intervention Description
Biological: CSL362

CSL362 is humanized monoclonal antibody that targets the alpha chain of the interleukin 3 receptor (IL3Rα; 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01632852

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School
Chicago, Illinois, United States, 60611
United States, Maryland
Sidney Kimmel Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
CSL Limited
Study Director: Dr. Mark DeWitte CSL Limited
  More Information

Responsible Party: CSL Limited Identifier: NCT01632852     History of Changes
Other Study ID Numbers: CSLCT-AML-11-73
Study First Received: June 29, 2012
Last Updated: October 8, 2015

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on April 21, 2017