Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia

September 14, 2009 updated by: CSL Limited

Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by uncontrolled proliferation of the myeloid line of white blood cells and impaired production of normal blood cells. If untreated, patients die of infection or bleeding usually in a matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the cells that are thought to drive AML but that are not effectively killed by standard treatment. The aims of the study are to determine a biologically active dose of CSL360 and generate understanding of a rational schedule of administration for future studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Institute of Medical & Veterinary Science
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Peter Maccallum Cancer Institute
      • Melbourne, Victoria, Australia, 3052
        • Royal Melbourne Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of acute myeloid leukemia
  • Recent bone marrow biopsy
  • Prior treatment or medically unfit for standard therapy

Exclusion Criteria:

  • Peripheral blood blast count > 30 x 109/L, or rapidly progressive AML
  • Previous solid organ transplant
  • Active GvHD or immunosuppression
  • Concurrent treatment with other anti-cancer therapy
  • Active infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I
Treatment with CSL360
Drug: CSL360
Weekly IV Infusion. Dose escalation study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events, pharmacokinetics
Time Frame: September 2009
September 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose
Time Frame: September 2009
September 2009
Partial, complete and overall response
Time Frame: September 2009
September 2009
Biological activity
Time Frame: September 2009
September 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Limited

Investigators

  • Principal Investigator: Andrew Roberts, Dr, Melbourne Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

November 16, 2006

First Submitted That Met QC Criteria

November 16, 2006

First Posted (Estimate)

November 20, 2006

Study Record Updates

Last Update Posted (Estimate)

September 16, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSLCT-AML-06-26

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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