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A Randomised phase II trial of Imatinib (IM) versus hydroxycholorquine (HCQ) and IM for patients with Chronic Myloid Leukaemia (CML) in Major Cytogenetic Response (MCyR) with residual disease detectable by quantitative polymerase chain reaction (Q-PCR).
Recruitment period: 
1 January 2012 to 19 December 2014
Trial period: 
1 January 2012 to 19 December 2014


For newly diagnosed patients: 

This trial has been completed

UK Multi centre

Chief Investigator: Prof Tessa Holyoake
Closure Date: 9/30/2014
Global Sample Size 66

Research Summary

This is a randomised phase 2 trial with a safety run-in, designed to study the safety and efficacy of HCQ in combination with Imatinib. CML CP patients who are in MCyR after >1 and <3 years of Imatinib treatment and tolerating Imatinib well will be randomised between Imatinib alone and Imatinib and HCQ 800mg/day. Imatinib will be given at the patient’s current stable dose. Treatment will be given continuously. Treatment with IM + HCQ will be continued for 12 cycles to further study tolerance and to study the efficacy of the combination to reduce or eliminate BCR/ABL+ cells. 33 patients will be randomised to each treatment to a total of 66 patients, recruited in 3 centres. Time required for accrual of all patients is anticipated to be 24 months. Time on study IM + HCQ treatment for each patient is 12 months. Follow-up assessments for each patient continue to 24 months. All patients will continue on their daily dose of Imatinib treatment that they were receiving prior to entry in the trial.