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

Primary Purpose

Acute Myeloid Leukemia (AML)

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
CSL360
Sponsored by
CSL Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Westmead Hospital
  • Royal Brisbane and Women's Hospital
  • Princess Alexandra Hospital
  • Institute of Medical & Veterinary Science
  • Peter MacCallum Cancer Institute
  • Royal Melbourne Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I

Arm Description

Treatment with CSL360

Outcomes

Primary Outcome Measures

Adverse events, pharmacokinetics

Secondary Outcome Measures

Maximum tolerated dose
Partial, complete and overall response
Biological activity

Full Information

First Posted
November 16, 2006
Last Updated
September 14, 2009
Sponsor
CSL Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00401739
Brief Title
Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia
Official Title
Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CSL Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia (AML)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Treatment with CSL360
Intervention Type
Drug
Intervention Name(s)
CSL360
Intervention Description
Weekly IV Infusion. Dose escalation study.
Primary Outcome Measure Information:
Title
Adverse events, pharmacokinetics
Time Frame
September 2009
Secondary Outcome Measure Information:
Title
Maximum tolerated dose
Time Frame
September 2009
Title
Partial, complete and overall response
Time Frame
September 2009
Title
Biological activity
Time Frame
September 2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Roberts, Dr
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Institute of Medical & Veterinary Science
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Peter MacCallum Cancer Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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