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

This study is currently recruiting participants.
Verified June 2013 by CSL Limited
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT01632852
First received: June 29, 2012
Last updated: June 12, 2013
Last verified: June 2013
History of Changes
  Purpose

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: Endpoint Classification: Safety Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: July 2012
Estimated Primary Completion Date: March 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632852

Contacts
Contact: Clinical Trial Registration Coordinator csl.clinicaltrials@csl.com.au

Locations
United States, Maryland
Sidney Kimmel Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Use Central Contact            
Principal Investigator: B. Douglas Smith            
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Use Central Contact            
Principal Investigator: Gail Roboz            
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Use Central Contact            
Principal Investigator: Roland B. Walter            
Australia, Victoria
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: Use Central Contact            
Principal Investigator: Andrew Roberts            
Sponsors and Collaborators
CSL Limited
Parexel
Investigators
Study Director: Dr. Mark DeWitte CSL Limited
  More Information

No publications provided

Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT01632852     History of Changes
Other Study ID Numbers: CSLCT-AML-11-73
Study First Received: June 29, 2012
Last Updated: June 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
 Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013