European Leukemia Trial Registry
Trial: BFORE (AV001)

More Details
Title Phase 3 study of Bosutinib versus Imatinib in adult patients with de novo CP-CML
Scientific Title A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase (CP) Chronic Myelogenous Leukemia (CML)
Short Title BFORE (AV001)
Trialgroup NN
Type of Trial multicentric, randomized, open-label, double-group
Disease Chronic myeloid leukemia(CML) Chronic Phase
Age >= 18 years
Status No longer recruiting
Start of Recruitment 01.09.2014
Leader Brümmendorf, Prof. Dr. med., Tim H.
Contactperson

Principal Investigator
Brümmendorf, Prof. Dr. med., Tim H.
Tel: +49 (0)241 80-89805
Fax: +49 (0)241 80-82449
Email: tbruemmendorf@ukaachen.de

Principal Investigator
Hochhaus, Prof. Dr. med., Andreas
Tel: +49 (0)3641 932 4201
Fax: +49 (0)3641 932 4202
Email: andreas.hochhaus@med.uni-jena.de

Principal Investigator
Saußele, Prof. Dr. med., Susanne
Tel: +49 (0)621 383-6966
Fax: +49 (0)621 383-73 1500
Email: studien.haematologie@medma.uni-heidelberg.de

Principal Investigator
Niederwieser, Prof. Dr. med. Dr. h.c., Dietger
Tel: +49 (0)341 971 3050
Fax: +49 (0)341 971 3059
Email: dietger@medizin.uni-leipzig.de

Shortprotocol Shortprotocol
Remark The study will be open for enrollment until the planned number of approximately 500 Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+ patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All patients will be treated and/or followed for 5 years (240 weeks) after randomization until the study has closed. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to 5 years (240 weeks) after randomization. Primary Outcome Measures: Compare proportion of participants with Major Molecular Response (MMR) at 12 Months in the bosutinib arm with that of the imatinib arm [ Time Frame: 12 Months ] [ Designated as safety issue: No ] MMR is defined as <0.1%Bcr-Abl1 on the International Scale (IS) by Real Time Quantitative Polymerase Chain Reaction (RT-PCR) Secondary Outcome Measures: Compare proportion of participants with MMR at 18 Months in the bosutinib treatment group with the imatinib treatment group [ Time Frame: 18 Months ] [ Designated as safety issue: No ] To determine the duration of MMR in the bosutinib treatment group with the imatinib treatment group [ Time Frame: 5 Years ] [ Designated as safety issue: No ] Duration of MMR is measured only for participants who initially respond to study medication. To determine the proportion of participants with Complete Cytogenetic Response (CCyR) by 12 Months in both treatment groups [ Time Frame: 12 Months ] [ Designated as safety issue: No ] CCyR is defined as absence of detectable Ph chromosomes in bone marrow aspirate To determine the duration of CCyR in both treatment groups [ Time Frame: 5 Years ] [ Designated as safety issue: No ] Duration of response is measured only for participants who initially respond to study medication.
created 24.09.2014 Hanna Ebert
changed 14.11.2016 Eva-Maria Ableidinger
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