SGI-110 versus TreatmentChoice in Adults with Previously Untreated AML

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 versus Treatment Choice (TC) in Adults with Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy

• IRAS ID

  178539

• Contact name

  Ghulam Mufti

• Contact email

  ghulam.mufti@nhs.net

• Sponsor organisation

  Astex Pharmaceuticals, Inc.

• Eudract number

  2014-001233-89

• Clinicaltrials.gov Identifier

  NCT02348489

• Duration of Study in the UK

  2 years, 5 months, 1 days

• Research summary

  This study will investigate the efficacy of a new medication called SGI-110 in treating patients with previously untreated acute myeloid leukaemia (AML) who are not considered candidates for intensive remission induced chemotherapy, by comparing SGI-110 to current treatment choice / standard of care.
  Leukaemia begins in bone marrow cells (the soft inner part of some bones) and spreads into the blood system. AML is one of the most common types of leukaemia in adults, yet continues to have the lowest survival rate of all leukaemias. AML is fast growing and if left untreated will be fatal.

  After diagnosis, young AML patients will immediately be treated to reduce the amount of leukaemia cells as quickly as possible, which is called intensive remission induction therapy. The goal is complete removal of the cancer and to maintain this disease-free state. Yet for elderly AML patients, intensive chemotherapy is often inappropriate due to disease factors that cause resistance to the treatment, or because they are suffering from additional medical conditions that, if undergoing this treatment, would lead to serious side effects.
  No standard therapy exists for patients with previously untreated AML who are not candidates for intensive remission induction chemotherapy.

  The study medication SGI-110 has been specifically designed to protect and to gradually release the active substance, decitabine. Prolonged exposure time is predicted to increase efficiency of decitabine to treat AML.
  This study will compare SGI-110 with the available treatment choices. We are interested in whether SGI-110 may be more effective and whether it may have fewer side effects.
  The only way we can address these questions with confidence and without bias, is by conducting a large clinical trial in which consenting patients are randomly allocated to two treatment groups, and their outcome of these two different approaches studied and compared across time.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  15/ES/0076

• Date of REC Opinion

  16 Jul 2015

• REC opinion

  Further Information Favourable Opinion