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Completed

NCT Number: NCT01632852

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

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.

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Key information

Conditions

Leukemia, Myeloid, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Melbourne Hospital, Parkville, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CSL362

Biological

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CSL Limited

Industry

Collaborators

  • Parexel

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
First posted
Jul 3, 2012
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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