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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Myeloid Leukemia (AML)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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I

Treatment with CSL360

Group Type EXPERIMENTAL

CSL360

Intervention Type DRUG

Weekly IV Infusion. Dose escalation study.

Interventions

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CSL360

Weekly IV Infusion. Dose escalation study.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No