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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01632852
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : October 9, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Biological: CSL362 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2012
Actual Primary Completion Date : August 2015

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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)

  2. Number of subjects developing antibodies against CSL362 [ Time Frame: From the first treatment (Day 1) up to approximately Day 106 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01632852

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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
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Study Director: Dr. Mark DeWitte CSL Limited
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Responsible Party: CSL Limited Identifier: NCT01632852    
Other Study ID Numbers: CSLCT-AML-11-73
First Posted: July 3, 2012    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type