Phase I in Leukaemia/Lymphoma Patients NO21279 version E

• Research type

  Research Study

• Full title

  A multi-centre, open-label, Phase I study of single agent RO5045337 administered orally in patients with acute myelogenous leukaemia (AML), acute lymphocytic leukaemia (ALL), chronic myelogenous leukaemia (CML) in blast phase, or refractory chronic lymphocytic leukaemia/small cell lymphocytic lymphoma (CLL / SCLL)

• IRAS ID

  23153

• Contact name

  Peter Hillmen

• Sponsor organisation

  Roche Products Limited

• Eudract number

  2009-010591-20

• ISRCTN Number

  n/a

• Research summary

  This clinical research study is being sponsored by Roche Products Ltd and is under the direction of Professor Peter Hillmen and his study staff. The purpose of this research is to find out the safest dose of the medication RO5045337 which can be administered to patients with leukaemia/lymphoma. If the first dose is safe each new group of patients will receive a higher dose of the drug than the previous group. We are doing this to understand what dose can be given without serious side effects. Once the highest dose(s) which is tolerated has been established then additional patients will be treated at this dose(s).

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/78

• Date of REC Opinion

  1 Sep 2009

• REC opinion

  Further Information Favourable Opinion