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

C

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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