Chronic Myeloid Leukaemia Clinical Trial
Official title:
Phase II Study of Nilotinib Plus Pegylated Interferon Alfa-2b as First-line Therapy in Chronic Phase Chronic Myelogenous Leukaemia Aiming to Maximize Complete Molecular Response and Major Molecular Response.
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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