Nilotinib Therapy After Reduced Intensity Conditioned Transplantation

• Research type

  Research Study

• Full title

  Phase I/II Study of the Adjunctive Use of Nilotinib in Patients Undergoing Reduced Intensity Allogeneic Transplantation for Imatinib Resistant or Intolerant Chronic Myeloid Leukaemia

• IRAS ID

  6270

• Sponsor organisation

  University of Birmingham

• Eudract number

  2007-006439-29

• ISRCTN Number

  Awaiting

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Allogeneic stem celltransplantation is one of the only curative treatment options for many patientswith Chronic Myeloid Leukaemia (CML). However, it can often be associated withsignificant toxicity and therefore excludes many patients who are unfit totolerate such a regimen from undergoing the procedure. The advent of ReducedIntensity Conditioned (RIC) transplantation has reduced the associated toxicityof a full intensity transplant, allowing this potentially curative procedure tobe extended to a larger number of patients in whom transplantation wouldnormally have been excluded. However, RIC transplantation is associated with ahigher risk of disease relapse. Disease relapse is normally treated byadministering immune cells from the original transplant donor, however whengiven within the first year post-transplant, they can result in significanttoxicity. The aim of this Phase 1/2 study is to administer a targeted agent forCML, Nilotinib, to control any persistent disease and prevent relapse until atime when it is safe to administer donor cells. Patients will receive Nilotinibtherapy at 35 days post-transplant at a starting dose of 200mg daily,increasing to 200mg twice daily after two weeks and increasing again to 400mgtwice daily until 12 months post-transplant. Dose increases will only occur ifpatients are tolerating the treatment. The primary objective of the study issafety which will be monitored by regular blood tests, electrocardiograms(ECGs) and recording of adverse events. Disease levels and the outcome of thetransplant will be monitored by blood tests every three months for one yearpost transplant. Blood samples will also be taken to investigate how Nilotinibis metabolised. Fifteen patients will be recruited to the trial from fourhospitals in England.Novartis Pharmaceuticals will provide Nilotinib free of charge and will supportthe trial management costs.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  08/H0304/91

• Date of REC Opinion

  24 Oct 2008

• REC opinion

  Further Information Favourable Opinion