Phase 3 study of Azacitidine vs conventional care for AML patients

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Open-label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

• IRAS ID

  53147

• Contact name

  Michael Potter

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2009-012346-23

• Clinicaltrials.gov Identifier

  NCT01074047

• Research summary

  This phase 3, multicentre, randomised, open-label study compares Azacitidine (Vidaza©) with conventional care regimens for the treatment of older patients with newly diagnosed acute myeloid leukaemia (AML).AML is a fast-growing cancer of the blood and bone marrow. In AML, the bone marrow makes many unformed cells called blasts. Blasts normally develop into white blood cells that fight infection. However, the blasts are abnormal in AML. They do not develop and cannot fight infections. The bone marrow may also make abnormal red blood cells and platelets. The number of abnormal cells (or leukaemia cells) grows quickly. They crowd out the normal red blood cells, white blood cells and platelets the body needs. In this study we will compare the drug Azacitidine with currently available treatments to see if azacitidine is effective and safe for use in older people (65 years and older) who have newly diagnosed AML with greater than 30% bone marrow blasts. Azacitidine is an anti-cancer drug that belongs to a group of drugs known as DNA demethylating agents. These drugs change how diseased cells in the blood and bone marrow grow. Azacitidine is approved in the US, Canada, and the EU for the treatment of patients with myelodysplastic syndromes (another cancer of the blood and bone marrow) and for patients suffering from AML with 20% to 30% blasts in their bone marrow. It has not been approved for patients suffering from AML with greater than 30% blasts in their bone marrow and is experimental (being tested) in this study. Approximately 480 participants worldwide will participate in this study (240 on the Azacitidine arm and 240 on the conventional care regimen arm). There are 3 conventional care regimen options which will be assigned by the investigator before randomisation: Intensive chemotherapy; low dose cytarabine or; best supportive care only.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/60

• Date of REC Opinion

  9 Sep 2010

• REC opinion

  Further Information Favourable Opinion