Extension study for Chronic Myeloid Leukaemia
Research type
Research Study
Full title
An Open-Label Bosutinib Treatment Extension Study for Subjects with Chronic Myeloid Leukaemia (CML) who have previously participated in Bosutinib Studies B1871006 or B1871008.
IRAS ID
132963
Contact name
Jane Apperley
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2013-000691-15
Research summary
CML classically follows a three phase course with most subjects being diagnosed in an initial, chronic phase that shows few or minor symptoms, then progressing into a more advanced accelerated phase and then can culminate in a blast phase, a treatment-resistant form of acute leukaemia.\n\nThe aim of this study is to allow long term bosutinib treatment in participants with chronic or advanced phase Philadelphia + CML who received bosutinib in a previous Pfizer sponsored CML study (studies B1871006 & B1871008) and who may have the potential to receive clinical benefit from continued treatment with bosutinib. This study will also collect long term survival follow up data for bosutinib subjects initially treated in studies B1871006 and B1871008 including those who have discontinued treatment and are in the long term follow-up phase of the prior studies and those who have completed the prior study.\n\nThere will be about 500 people enrolled in this study. The study is being done at about 125 different research sites in about 32 countries, 3 sites will be in the UK. Participants who are currently receiving bosutinib will be entered into the Treatment Group portion of this study. Participants who have discontinued bosutinib will be asked to consent to Long Term Follow-Up. The study duration is up to 10 years from the original start of bosutinib treatment to final follow-up. Participants will be expected to attend hospital for screening procedures and either an annual visit to the research site or a 6 monthly visit depending on which treatment they are receiving. Participants will also receive 3 monthly phone contact and a 3-month hospital visit to collect safety information.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0349
Date of REC Opinion
23 Dec 2013
REC opinion
Further Information Favourable Opinion