AML 18 Pilot Trial

• Research type

  Research Study

• Full title

  To establish the feasibility of combining either the tyrosine kinase inhibitor AC220 or the CXCR4 inhibitor Plerixafor with chemotherapy in older patients with Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.

• IRAS ID

  58555

• Contact name

  Alan K Burnett

• Sponsor organisation

  Cardiff University, Research and Commercial Division

• Eudract number

  2010-021444-18

• ISRCTN Number

  n/a

• Research summary

  The AML18 Pilot Trial will evaluate the feasibility of two interventions that are planned to be included in the NCRI AML18 Trial. One intervention will be to evaluate combining the tyrosine kinase inhibitor AC220 with three courses of standard ADE (Ara-C, Daunorubicin, Etoposide). AC220 will be given following each treatment course, daily by mouth for 21 days. AC220 will be evaluated at two dose levels (90mg and 135mg). The second intervention to be tested is the combination of the CXCR4 inhibitor Plerixafor with up to three courses of the chemotherapy combination of DClo (Daunorubicin, Clofarabine). Patients/investigators will be able to choose which intervention to enter.

• REC name

  Wales REC 3

• REC reference

  10/MRE09/27

• Date of REC Opinion

  12 Oct 2010

• REC opinion

  Further Information Favourable Opinion