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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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 23, 2014
Last verified: June 2014
  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:


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: October 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
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 ClinicalTrials.gov identifier: NCT01632852

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

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School Recruiting
Chicago, Illinois, United States, 60611
Contact: Use Central Contact         
Principal Investigator: Jessica Altman         
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 23, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014