Pegylated Interferon Alfa-2b and Nilotinib for Augmentation of Complete Molecular Response in Chronic Myeloid Leukaemia
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The treatment of CML and the expected survival has been revolutionised since the introduction
of tyrosine kinase inhibitors (TKIs) such as nilotinib. Despite their effectiveness, these
drugs will never totally remove CML affected cells from the body. In order to achieve this
goal, and potentially enable CML patients to live without the daily need for TKIs, other
features of the patient's immune system may need to be harnessed. One possibility is using
externally administered interferon (IFN) to augment the response induced by the TKI.
This study will assess the response in terms of length of survival, detection of minimal
disease levels and time until disease worsens in patients with chronic phase CML who are
taking nilotinib and pegylated Interferon. Patients will commence taking nilotinib for 3
months, and once tolerated, will simultaneously be treated with injected pegIFN for up to 2
years. Patients can continue taking nilotinib beyond this time providing they are receiving
benefit. Options are available for patients to decrease or increase their dose or to switch
to another TKI, imatinib, to ensure a balance between drug effectiveness and minimal side
effects is achieved.