A pilot study exploring high-dose lenalidomide maintenance therapy in adult acute myeloid leukaemia (AML) (AMLM15)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 45 patients Dose escalation study Lenalidomide commenced in maintenance phase Demographic data, diagnostic data, treatment data, outcome data, disease and disease response measurements Close monitoring of response to drug Pathology design data Clinical outcome measurements
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Chemotherapy |

Source Study

Trial acronym


Trial ID





Phase 1


Other Collaborative groups,Australasian Leukaemia and Lymphoma Group (ALLG)

Scientific enquiries

Andrew Wei

Brief Summary

Lenalidomide has a variety of reported mechanisms in blood malignancy, including activation of immune cells and anti-proliferative effects on tumor cells and modulation of the bone marrow microenvironment. Currently approved doses of lenalidomide use up to 25 mg for 21 days out of 28. A recent pilot study in older AML patients used higher and continuous doses of lenalidomide (50mg lenalidomide for 28 days x 2 cycles followed by 10 mg daily for 12 months). This resulted in a 30% complete response ....
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Key Inclusion Criteria

Subjects aged 15 - 65 years at screening. Newly diagnosed acute myeloid leukaemia (except APML) with morphology according to the World Health Organisation (WHO) criteria and confirmed by immunophenotyping. This can include de-novo and secondary/therapy related AML. The inclusion of patients with core binding factor AML and the presence of Fms-like tyrosine kinase 3 (FLT3) mutations will be allowable if patients are not enrolled for other studies targeting these disease groups. Has provided writt ....
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Key Exclusion Criteria

History of major non-compliance to medication. Evidence of known central nervous system (CNS) leukaemia. Currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that, in the nvestigator’s opinion, prevents the patient from absorbing or taking oral medication. Any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, ....
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Can healthy volunteers participate?




Sample Size    45

Min. age    15 Years

Max. age    65 Years

Sex    Both males and females

Condition category    Newly diagnosed acute myeloid leukaemia (except Acute promyelocytic leukaemia (APML))

Condition code    Cancer


Intervention code Treatment: Drugs

Daily oral lenalidomide maintenance therapy for consecutive 28 day cycles. The first two cycles will be 'high dose' lenalidomide (10-50mg depending on which of 5 cohorts is currently accruing patients), and then patients will complete up to 10 additional 28 day cycles of 10mg oral lenalidomide daily. Cohort 1: 10mg daily for first two cycles; then if approved by Trial Management Committee (TMC) Cohort 2: 25mg daily for first two cycles; then if approved by TMC Cohort 3: 30mg daily for first two ....
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Control group Uncontrolled



Outcome: Determination of maximum tolerated dose (MTD) from dose limiting toxicities (DLTs) occurring in the first cycle of lenalidomide maintenance therapy
Timepoint: Up to 28 days after the last evaluable patient from each cohort has completed 1 28 day cycles of 'high dose' lenalidomide therapy, the Trial management committee (TMC) will assess whether the next escalated dose cohort can commence accrual. The MTD will be the dose given to the cohort immediately preceding the ....

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Outcome: Adverse and serious adverse events during all cycles (up to 12 months) of Lenalidomide maintenance therapy as assessed by Common terminology criteria for Avderse Events (CTCAE) version 4 criteria
Timepoint: 12 months after final patient was accrued to the study.

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