EWALL-Ph-03

• Research type

  Research Study

• Full title

  An open label, 2-arm, Randomised phase II study to Compare the Safety and Efficacy of Ponatinib plus Chemotherapy with Imatinib plus Chemotherapy as front-line therapy for patients aged 55 years and over with Philadelphia chromosome positive (Ph+ or BCR-ABL+) acute lymphoblastic leukemia (ALL)

• IRAS ID

  251520

• Contact name

  Oliver Ottmann

• Contact email

  OttmannO@cardiff.ac.uk

• Sponsor organisation

  Cardiff University

• Eudract number

  2018-003350-25

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT00000000

• Duration of Study in the UK

  6 years, 11 months, 30 days

• Research summary

  The main purpose of this trial is to determine whether ponatinib is superior to imatinib when combined with the same chemotherapy that is considered a standard for elderly patients with Ph+ ALL. This will be done by randomly assigning patients in a 1:1 ratio to treatment with the same chemotherapy regimen combined with either imatinib (standard treatment) or ponatinib.
  Overall duration of study treatment will be 2 years, followed by treatment with a tyrosine kinase inhibitor. The study hypothesis is that a greater proportion of patients in the ponatinib arm will achieve a deep (molecular) response, and that survival without relapse will be superior. The side effects, safety and tolerability of the two treatment regimens will also be compared.

• REC name

  Wales REC 3

• REC reference

  19/WA/0194

• Date of REC Opinion

  30 Jul 2019

• REC opinion

  Further Information Favourable Opinion