NCT01632852

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2015

Enrollment Period

3.1 years

First QC Date

June 29, 2012

Last Update Submit

October 8, 2015

Conditions

Leukemia, Myeloid, Acute

Outcome Measures

Primary Outcomes (2)

  • Frequency and Severity of Adverse Events (AEs)

    Number of subjects reporting any AEs and the severity of those AEs.

    From the first treatment (Day 1) up to approximately Day 106

  • Dose-limiting toxicity (DLT) evaluation

    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.

    From the first treatment (Day 1) up to approximately Day 106

Secondary Outcomes (2)

  • Pharmacokinetic (PK) Parameters

    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

  • Number of subjects developing antibodies against CSL362

    From the first treatment (Day 1) up to approximately Day 106

Study Arms (1)

CSL362

EXPERIMENTAL

See Intervention Description

Biological: CSL362

Interventions

CSL362BIOLOGICAL

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.

CSL362

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Robert H. Lurie Comprehensive Cancer Center of Northwestern University Medical School

Chicago, Illinois, 60611, United States

Location

Sidney Kimmel Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Dr. Mark DeWitte

    CSL Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2012

First Posted

July 3, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2015

Last Updated

October 9, 2015

Record last verified: 2015-10

Locations

US(4)AU(1)