AT9283 in children and adolescents with acute leukaemia

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 7

Inclusion Criteria

1. Morhologically proven acute lymphoblastic or acute myeloid leukaemia
2. Life expectancy of at least 8 weeks
3. Karnofsky / Lansky scale score of > or = to 50%
4. Biochemical indices within ranges as specified in the protocol
5. Aged > 6 months to <19 years
6. Written informed consent

Exclusion Criteria

1. Chronic myeloid leukaemia
2. Cytotoxics, vincristine, anti-neoplastics within two weeks. One week for investigational medicinal products (except antibodies, for which a four week window must be observed), one week for protein kinase inhibitors and Intrathecal therapy before treatment
3. Central nervous system (CNS) disease
4. Ongoing toxic manifestations of previous treatments
5. Prior exposure to an aurora kinase inhibitor
6. Pregnant or lactating women
7. Fractional shortening of =29% on Echocardiogram
8. Previous anthracycline treatment with a cumulative dose equal to or greater than 450mg/m2 doxorubicin equivalent
9. Uncontrolled arterial hypertension defined as a systolic and / or diastolic blood pressure greater than or equal to the 95th percentile for age and height
10. Congenital heart disease, with the exception of patent foramen ovale or small muscular ventricular septal deficit (within the first year of life)
11. Active graft vs. host disease
12. Patients experiencing significant toxicity following Haematopoietic Stem Cell Transplant.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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