A Strategy of High-Dose Lenalidomide in Combination with Epigenetic Therapies for Relapsed or Refractory Acute Myeloid Leukaemia (AML)- Phase II (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 2


Other Collaborative groups,Australasian Leukaemia and Lymphoma Group

Scientific enquiries

A/Prof 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 compare various chemtherapy combinations, comprising romidepsin and high dose lenalidomide, azacitidine and lenalidomide and high dose lnealiodmide alone in the treatment of advanced AML. The study plans to treat 120 patients in a number of sites throughout Australia and New Zealand. This st ....
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Key Inclusion Criteria

1. Male or female patients with one of the following diagnoses: a. AML failing previous therapy who are not eligible for transplant or who failed to be salvaged by standard therapy. Patients may be 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 hy ....
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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 ventricular ejection fraction (LVEF) <45% as determined by Multi-gated Acquisition (MUGA) scan or echocardiogram (ECHO) b. Complete left bundle branch block or right bu ....
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Can healthy volunteers participate?




Sample Size    120

Min. age    18 Years

Max. age    80 Years

Sex    Both males and females

Condition category    relapsed and refractory acute myeloid leukaemia

Condition code    Cancer


Intervention code Treatment: Drugs

The Phase II follows on from a separate Phase I study that was designed to find the maximum tolerated dose (MTD) of intravenous (i.v) romidespin when delivered in conjunction with oral lenalidomide. The Phase I study can be found here The Phase II is a randomised study (1:1:1) comparing 50mg oral lenalidomide daily days 1-28 with either 50mg oral lenalidomide daily days 8-28 in combination with 75mg/m^2 subcutaneous (s.c) Azacitidine on days 1-5 ....
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Control group Active

The Phase II study will compare romidepsin and high dose lenalidomide with high dose lenalidomide alone (control) or high dose lenalidomide in combination with azacitidine


Outcome: To investigate the efficacy of two novel treatments (high dose lenalidomide + azacitidine and high dose lenalidomide + romidepsin) compared with a control treatment (high dose lenalidomide alone) in patients with relapsed or refractory AML as measured by the complete remission (CR) rate following two cycles of therapy. Complete remission will be measured by clinical investigations conducted at usual physician appointments.
Timepoint: After all patients have complete ....

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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