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A Strategy of High-Dose Lenalidomide in Combination with Epigenetic Therapies for Relapsed or Refractory Acute Myeloid Leukaemia (AML)- Phase I
Australasian Leukaemia and Lymphoma Group (ALLG)
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 initial study is to find a safe dose of romidepsin when delivered with high dose lenalidomide. This initial stage of the study will flow into a larger study comparing 3 different treatments in advanced AML, however if you participate in this Phase I study, you will not then be eligible for the following Phase II study.
Trial details: In this study you will receive the drug romidespin delivered intravenously (i.v) on days 1,8 and 15 of a 6-week treatment cycle at a dose of either 8, 10, 12 or 14mg/m^2, or on days 1 and 15 at 8mg/m^2. The actual dose will depend on what stage of the trial is currently open. At the same time as the romidespin treatment, you will also receive 50mg oral lenalidomide on a daily basis on days 8-28. The strength of the drug and your tolerance of it will be assessed after 2 cycles, and overall, your treatment should continue for at least 6-12 cycles. Beyond this time, the decision as to whether or not your treatment continues will be at the discretion of the study's Principal Investigator (PI).
Who is it for? This study is open to male or female patients aged 18-80 with either a diagnosis of Acute Myeloid Leukaemia (AML) and failing previous therapy, either primary refractory or relapsed after no more than 3 previous lines of chemotherapy OR a diagnosis of Myelodysplasia transformed to AML after previous treatment. The full details of this studyâ€™s inclusion and exclusion criteria can be found in the relevant sections within this record.