A comparison of AZD1152 alone and in combination with LDAC in AML

• Research type

  Research Study

• Full title

  A randomised, open-label, multi-centre, 2-stage, parallel group study to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in patients aged = 60 with newly diagnosed acute myeloid leukaemia (AML) who are considered unsuitable to receive intensive induction chemotherapy regimens

• IRAS ID

  27614

• Sponsor organisation

  Astra Zeneca AB

• Eudract number

  2009-010114-30

• ISRCTN Number

  N/A

• Research summary

  This study will evaluate a new drug called AZD1152, which is being tested for the treatment of Acute Myeloid Leukaemia (AML). AZD1152 is thought to work by switching off the activity of some proteins that are present in leukaemia cells. This action stops the cells from dividing normally, which eventually leads to their death. Some AML patients are not able to have intensive chemotherapy (which aims to kill off all leukaemia cells), for example those who are elderly or less fit. These patients usually have less intensive treatment aimed at controlling the leukaemic cells rather than getting rid of them completely. Standard non-intensive treatment involves the use of a low dose of a drug called cytarabine (LDAC). Although this is effective in some patients, outcomes are generally poor. It is hoped that combining or replacing LDAC with new drugs in development such as AZD1152 will improve overall treatment results. This study will be in two parts. Stage 1 will look at the therapeutic effect of AZD1152 and how well people can tolerate the drug, compared with LDAC. Stage 2 will assess whether AZD1152, either alone or in combination with LDAC, is a better treatment for AML than LDAC alone. Participants will be >60 years and have newly diagnosed AML, and not be suitable for intensive chemotherapy. They will be allocated a treatment by chance. They will be expected to attend study visits whilst on study medication, at which various assessments will take place. Patients will need to remain in hospital for a number of days and nights. Participants will receive treatment in this study for a minimum of 3 months or until they or their study doctor feels it is their best interest to stop. They will then receive a follow-up phone call every month. This study is being funded by AstraZeneca.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  09/H1107/94

• Date of REC Opinion

  13 Oct 2009

• REC opinion

  Further Information Favourable Opinion