Spots Global Cancer Trial Database for Pegylated Interferon Alfa-2b and Nilotinib for Augmentation of Complete Molecular Response in Chronic Myeloid Leukaemia
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Trial Identification
Brief Title: Pegylated Interferon Alfa-2b and Nilotinib for Augmentation of Complete Molecular Response in Chronic Myeloid Leukaemia
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.
Study ID: NCT02001818
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Contact Details
Name: Tim Hughes, MBBS, MD, FRACP, FRCPA
Affiliation: Royal Adelaide Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Andrew Grigg, MBBS, MD, FRACP, FRCPA
Affiliation: Austin Hospital, Melbourne Australia
Role: PRINCIPAL_INVESTIGATOR
Name: David Yeung, BSc(Med), MBBS(Hons),FRACP
Affiliation: SA Pathology
Role: PRINCIPAL_INVESTIGATOR
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