Dasatinib in paediatric patients with Ph+ ALL

• Research type

  Research Study

• Full title

  A Phase 2 Multi-Center, Historically-Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

• IRAS ID

  87939

• Contact name

  Vaskar Saha

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2011-001123-20

• Clinicaltrials.gov Identifier

  NCT01460160

• Research summary

  Research Summary:
  Dasatinib in paediatric patients with Philadelphia positive (Ph) Acute Lymphoblastic Leukaemia (ALL): Leukaemia is a disease of the blood. There are different types of leukaemia depending on how quickly it develops and the type of cells affected. ALL is a fast-growing (acute) cancer that affects the white blood cells (lymphocytes). This study is looking at a specific type of ALL where an abnormal chromosome called the Philadelphia chromosome is present (Ph ALL). Leukaemia is the most common childhood cancer. ALL accounts for around 80% of all leukaemias diagnosed in children. Around 300 new cases of childhood ALL are diagnosed every year in Great Britain. The Philadelphia chromosome occurs in about 3-4% of children with ALL.There have been many advances in the treatment of childhood leukaemia over the last 2 decades, but there is still a need to improve treatments, particularly for those patients who don??t respond or relapse on current therapies. A type of drug called tyrosine kinase inhibitors, like dasatinib, target the Philadelphia chromosome and may have potential to help improve response rates. This study aims to find out if dasatinib, when added to standard chemotherapy, improves the response rate of treatment of children with Ph ALL. In this study 75 patients will receive standard chemotherapy treatment plus dasatinib for up to 2 years. The chemotherapy will be given in blocks according to a standard, predefined chemotherapy regimen. Patients will be followed for up to 5 years to see how they are doing after treatment. Patients will be carefully monitored throughout the study, they will undergo: physical examinations, multiple blood tests, chest x-rays, heart functions tests and bone marrow aspirations. The study is funded by Bristol-Myer Squibb. It has been developed in collaboration with the Children??s Oncology Group in America and the academic group EsPhALL in Europe.

  Summary of Resuts:
  https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdj8o1FpylFwbn362DUDJ-2Fz5HFDHrLBouSrjbKC-2FPJR3YdLd-2FbmBz-2BuRQHKwFtBwXaRGASq2-2F-2FZ0-2FDyDRnf-2By0MxDre_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKeyAalwpVAOl-2Fu9hdgsex7xqeDgaimqfrpJHyG8sFMmMODck8hNYHVNPz8ISkArHMHproZf85RnddhIlkPgZ9E199JQr1xCq415EclhCreP4Hx3RGO3siy2JALupBOWFWGm-2F2jU0bkXEoZ50LDdMZuPzJm4EBjRLBWR70FocNJpQ-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7Cee11022724ae482e460b08d9f06ed868%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637805181158798739%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=dt3rVcDmYHTLLRd5RuBkjwWb%2FUisBq3NDXn6gv0D4Jg%3D&reserved=0

• REC name

  Wales REC 3

• REC reference

  11/WA/0363

• Date of REC Opinion

  29 Feb 2012

• REC opinion

  Further Information Favourable Opinion