Clofarabine pre-conditioning with allogeneic transplant for AML

• Research type

  Research Study

• Full title

  A Pilot Study of Clofarabine Pre-Conditioning Prior to Full or Reduced Intensity Allogeneic Transplantation in the Treatment of High Risk Acute Myeloid Leukaemia and Myelodysplasia

• IRAS ID

  11581

• Contact name

  Doctor Deborah Susan Richardson

• Eudract number

  2008-007043-14

• Research summary

  Allogeneic (donor) stem cell transplantation is an established, potentially curative therapy for patients with Acute Myeloid Leukaemia (AML) but the outcome for patients with high risk disease, particularly those with leukaemia present at the time of transplantation, remains poor, even when using full intensity, total body irradiation-based transplant preparation (or conditioning) schedules. For patients with refractory leukaemia, who are not eligible for a full intensity transplant, there are few therapeutic options; the results of reduced intensity allogeneic transplantation in these patients with active leukaemia at the time of transplantation are especially poor.The mortality associated with attempting to achieve remission by giving further intensive chemotherapy in patients for whom initial chemotherapy fails, is high as it is associated with an extended period before blood count recovery, exposing the patient to significant risks from complications including severe infection, which may then preclude subsequent transplantation. The chemotherapy drug Clofarabine, has significant activity as a single agent for the treatment of AML and is well tolerated. These characteristics suggest that Clofarabine would be an ideal drug to use as pre-conditioning therapy, that is, to reduce the leukaemia burden before proceeding rapidly to stem cell transplantation, without waiting for blood count recovery. This study will evaluate the feasibility and safety of using Clofarabine in order to reduce disease burden, before proceeding to either full or reduced intensity allogeneic transplantation, in patients with high risk acute myeloid leukaemia or myelodysplasia (MDS).

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  10/S0501/51

• Date of REC Opinion

  13 Sep 2010

• REC opinion

  Favourable Opinion