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

CSL Limited

Status and phase: Completed; Phase 1

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Drug: CSL360

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401739

CSLCT-AML-06-26

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

I

Experimental group

Description:

Treatment with CSL360

Treatment:

Drug: CSL360