coiaward2010

CHOICES = Imatinib Mesylate With or Without Hydroxychloroquine in Treating Patients With Chronic Myeloid Leukemia

Study title

CHOICES = Imatinib Mesylate With or Without Hydroxychloroquine to Eliminate Malignant Stem Cells in Patients With Chronic Myeloid Leukemia [Europe]

Scientific title

A Randomized Phase II Trial of Imatinib (IM) Versus Hydroxychloroquine (HCQ) and IM for Patients With Chronic Myeloid Leukemia (CML) in Major Cytogenetic Response (MCyR) With Residual Disease Detectable by Quantitative Polymerase Chain Reaction (Q-PCR) (EudraCT 2009-014373-41, ClinicalTrials.gov NCT01227135)

Indication and most important inclusion criteria

Chronic myeloid leukemia (CML) in chronic phase (CP)
Potential participants should have received imatinib mesylate for at least 1 year, and received a stable dose for at least 6 months. They should have achieved at least major cytogenetic response (MCyR) and continue to be BCR/ABL-positive by quantitative polymerase chain reaction (Q-PCR).

Short description of intervention

This trial is conducted to analyze the benefits and side effects of giving imatinib mesylate with or without hydroxychloroquine in patients with chronic myeloid leukemia. Patients will receive treatment for up to 12 months during the study period and possibly for up to 12 months during the follow-up period.

Type of study

Treatment optimization trial

Current status

No longer recruiting

Study sponsor

NHS Greater Glasgow and Clyde
Funded by Medical Research Council and supported by Cancer Research UK Trials unit Glasgow

Scientific lead / contact

Lynn McMahon
University of Glasgow

Principal investigator

Holyoake, Prof. Dr. Tessa
Gartnavel General Hospital
Institut of Cancer Sciences

Additional information

Patient Information Sheet

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Short protocol in European LeukemiaNet

Study centers / principal investigators


United Kingdom


Glasgow
Gartnavel General Hospital
Institut of Cancer Sciences
Prof Dr Tessa Holyoake

Leeds
St James University Hospital Leeds
Dr Graeme Smith

Liverpool
Royal Liverpool University Hospital
Prof Richard E. Clark

London
Addenbrookes Hospital
Dr Brian Huntley

Imperial College London
Dr David Marin

Nottingham
Nottingham University Hospital
Dr Jenny Byrne


France

Lyon
Hospices Civils de Lyon
Dr Franck Nicolini


Germany


Uniklinik RWTH Aachen
Klinik für Onkologie, Hämatologie und SZT
Prof. Dr. med. Steffen Koschmieder

Universitätsklinik Hamburg-Eppendorf
PD Dr. med. Philippe Schafhausen