0301 – Phase 3 study of ASP2215 vs salvage chemotherapy in AML patient

• Research type

  Research Study

• Full title

  A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FLT3 Mutation

• IRAS ID

  181796

• Contact name

  Eleni Tholouli

• Contact email

  eleni.tholouli@cmft.nhs.uk

• Sponsor organisation

  Astellas Pharma Global Development, Inc. (APGD)

• Eudract number

  2015-000140-42

• Duration of Study in the UK

  years, months, days

• Research summary

  This is an open-label, randomised study to compare ASP2215 therapy to salvage chemotherapy in participants with Acute Myeloid Leukaemia (AML).

  Participants will be adults according to local regulations with FLT3-mutated gene AML who are refractory (leukaemia cells resistant to treatment) or have relapsed (return of AML) after their first treatment for AML.

  The study drug to be investigated is ASP2215. Salvage chemotherapy options include LoDAC, azacitadine, MEC or FLAG-IDA. The study will compare the efficacy and safety of ASP22015 to salvage chemotherapy as shown by overall survival.

  369 participants will be recruited in approximately 125 global centres, including centres in UK and Ireland. Participants will be randomised in a 2:1 ratio to receive either ASP2215 or pre-selected salvage chemotherapy.

  Treatment will be administered over continuous 28-day cycles. ASP22015 is given orally and salvage chemotherapy as per local policy. Participants allocated to ASP22015/LoDAC/azacidadine will continue treatment until the participant requires treatment discontinuation. Those randomised to MEC/FLAG-IDA will receive 1 cycle of therapy and will be assessed for response after day 15. The participant will then receive a second treatment cycle or will be observed for recovery. Those with no response or progressive disease will discontinue study treatment. Participants may undergo a Stem Cell Transplant while on study, if appropriate.

  Participants will attend a minimum of 8 scheduled clinic visits, from screening to long-term follow up, plus further visits for additional treatment cycles. Procedures include physical exams, chest x-rays, ECGs, MUGA/ECHOs, bone marrow aspirates and/or biopsies, blood and urine samples and ophthalmologic assessments. PK samples will also be collected during the study. There is an optional genetic sub-study available to participants, which involves the collection of an extra blood sample and a cheek swab.

  The Sponsor is Astellas Pharma Global Development, Inc.

  Result Summary
  Summary results will be posted at the following links:

  Clinicaltrials.gov
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT02421939%2FNBTI%2Fb-m_AQ%2FAQ%2F267a9180-0adc-4f95-819c-ae513dc5849d%2F1%2FRcEM7ncVLH&data=05%7C02%7Cgmsouth.rec%40hra.nhs.uk%7Ca1b38ffc5c244578dab408ddcda5d82b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638892834363461469%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=xBEp40pAYMISoIOd%2FgSK6p90KkeDn%2B%2B33OPqUQMiyls%3D&reserved=0

  EudraCT:
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.clinicaltrialsregister.eu%252Fctr-search%252Fsearch%253Fquery%253D2015-000140-42%2FNBTI%2Fb-m_AQ%2FAQ%2F267a9180-0adc-4f95-819c-ae513dc5849d%2F2%2FFb3cZ5hosY&data=05%7C02%7Cgmsouth.rec%40hra.nhs.uk%7Ca1b38ffc5c244578dab408ddcda5d82b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638892834363512166%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=VSuJshEDr9JcQgEyO9r9wsGKu8ketzo5nBzXTnJ%2F1S0%3D&reserved=0
  

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  15/NW/0827

• Date of REC Opinion

  18 Dec 2015

• REC opinion

  Further Information Favourable Opinion