ALLG AMLM17
ACTRN12612000312842
Treatment
Phase 2
Other Collaborative groups,Australasian Leukaemia and Lymphoma Group
A/Prof Andrew Wei
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 .... Read more
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 .... Read more
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 .... Read more
No
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 http://www.anzctr.org.au/trial_view.aspx?ID=343451 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 .... Read more
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 .... Read more
yes
De-identified IPD data for all data collected during the trial
Data available 3 months following publication, for an indefinite period
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.
Any type of analysis Assessed on a case-by-case basis