A Strategy of High-Dose Lenalidomide in Combination with Epigenetic Therapies for Relapsed or Refractory Acute Myeloid Leukaemia (AML)- Phase I (AMLM17)

Australasian Leukaemia and Lymphoma Group (ALLG)

Dataset description

Dataset includes: Data for 20 refractory AML patients Lenalidomide given at relapse of disease Demographic data, diagnostic, 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

Scientific enquiries

Dr Andrew Wei

Brief Summary

The outcome in patients with Acute Myeloid Leukaemia (AML) who fail to respond to treatment or relapse after treatment is extremely poor. There is no standard treatment for these patients. This study aims to investigate the appropriate dose of the drug romidepsin (a type of chemotherapy) delivered with high dose lenalidomide (a type of chemotherapy) in the treatment of advanced AML. The study plans to treat up to 18 patients in a number of sites throughout Australia. The primary aim of this init ....
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Key Inclusion Criteria

1.Male or female patients with one of the following diagnoses: a. AML failing previous therapy, either primary refractory (failure to achieve greater than or equal to 50% blast reduction to 10-25% marrow blasts) or relapsed (greater than or equal to 50% increase in blasts to greater than or equal to 10% bone marrow blasts) after no more than 3 previous lines of chemotherapy, which may include hypomethylating agents OR b.Myelodysplasia transformed to AML with greater than or equal to 20% bone mar ....
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Key Exclusion Criteria

1.History of major non-compliance to medication 2.Post allogeneic-stem cell transplant patients on immunosuppression therapy greater than or equal to 5mg prednisolone/day or equivalent 3.Evidence of central nervous system (CNS) leukaemia 4.Impaired cardiac function or clinically significant cardiac disease as follows: a. Left Ventricle Ejection Fraction (LVEF) <45% as determined by Multi-gated Acquisition (MUGA) scan or echocardiogram (ECHO) b. Complete left bundle branch block or right bundle b ....
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Can healthy volunteers participate?




Sample Size    20

Min. age    18 Years

Max. age    80 Years

Sex    Both males and females

Condition category    Relapsed or refractory Acute Myeloid Leukaemia (AML)

Condition code    Blood , Cancer


Intervention code Treatment: Drugs

The Phase I study aims to find the maximum tolerated dose (MTD) of intravenous (i.v) romidespin when delivered in combination with 50mg oral lenalidomide daily on days 8-28. Romidepsin will be delivered on days 1,8 and 15 at either 8, 10, 12 or 14mg/m^2, or on days 1 and 15 at 8mg/m^2. The actual dose administered depends on which dose cohort is currently open- for more information see 'other design features'. Cycles are 6 weeks and are continuous unless toxicity warrants withholding dose. Provi ....
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Control group Uncontrolled



Outcome: To determine the maximum tolerated dose of romidepsin when used in combination with lenalidomide for the treatment of patients with relapsed or refractory AML using information obtained from clinical investigations
Timepoint: 55 days following the first dose of treatment for the final accrued evaluable patient

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