A randomised trial of idarubicin dose escalation in consolidation therapy following intensive induction chemotherapy incorporating high dose cytarabine in patients with untreated adult acute myeloid leukaemia, to evaluate safety and improve remission rate.(AMLM12)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 42 patients Includes first Australian study conducted in AML using dose escalation therapy. Also investigates use of antiemetics and oral mucositis medication Demographic data, diagnostic data, treatment data, outcome data induction and consolidation treatment, including measurements for progression and clinical outcomes. Patients who underwent BMT were censored for this study
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Chemotherapy |

Source Study

Trial acronym


Trial ID





Phase 3


Commercial sector/Industry,Amgen Australia

Scientific enquiries

A/Prof Associate Professor Kenneth Bradstock

Brief Summary

Improvements in treatment results for adult acute myeloid leukaemia (AML) over the past 15 years have come mainly from the use of higher dose intensity of existing chemotherapy agents, rather than from the introduction of new classes of anti-leukaemic drugs. Increased dose intensity protocols have included the use of chemo-radiotherapy, Early intensification of treatment using the most effective drugs available for AML is a highly effective strategy, possibly through rapid elimination of potenti ....
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Key Inclusion Criteria

1. A morphological diagnosis of AML by WHO criteria, confirmed by special stains, immunophenotyping and cytogenetics. All clinico-pathological subtypes will be eligible, except for AML with t(15;17) or variants, or core-binding factor AML (t(8;21) or inv16 or variants). 2. ECOG performance status 0 to 3 inclusive. 3. Absence of serious cardiac, pulmonary, hepatic or renal disease. A serum creatinine <200 mmol/L and serum bilirubin < 2.5 times the upper limit of normal, unless medically correctab ....
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Key Exclusion Criteria

No exclusion criteria

Can healthy volunteers participate?




Sample Size    442

Min. age    15 Years

Max. age    60 Years

Sex    Both males and females

Condition category    Acute myeloid leukaemia

Condition code    Cancer


Intervention code Treatment: Drugs

Comparison of two dose levels of Idarubicin in the consolidation phase of chemotherapy for AML. All patients receive the same induction therapy with Idarubicin, high dose cytarabine, and etoposide. Complete responders are then randomised, and receive 2 courses of consolidation therapy with conventional dose cytarabine, etoposide, and Idarubicin at either standard dosage (9mg per square metre daily for 2 days) or in the experimental arm 9mg per square metre daily for 3 days.


Control group Active



Outcome: To study the effects of dose escalation of the anthracycline Idarubicin in consolidation treatment, following induction therapy incorporating high dose Cytarabine, on the rate of leukaemia â¿¿free survival at 3 years in younger patients with newly diagnosed de novo AML.
Timepoint: At 3 years.

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

De-identified IPD data, for all data collected during the trial

When will data be available?

Data available 3 months following publication, for an indefinite period

Available to whom?

Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.

Available for what types of analyses?

Any type of analysis Assessed on a case-by-case basis

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see