Deutsches Leukämie-Studienregister
Studie: BFORE (AV001)

Gesamtübersicht
Öffentlicher Titel Phase 3 Studie zu Bosutinib versus Imatinib in Erwachsenen mit de novo CP-CML
Wissenschaftl. Titel 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)
Kurztitel BFORE (AV001)
Studiengruppe NN
Studienart multizentrisch, randomisiert, offen, zweiarmig
Erkrankung Chronische myeloische Leukämie (CML) - Chronische Phase
Molekularer Marker BCR-ABL
Alter >= 18 Jahre
Status Rekrutierung beendet
Beginn der Rekrutierung 01.09.2014
Studienleiter/in Brümmendorf, Prof. Dr. med., Tim H.
Ansprechpartner

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

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

Principal Investigator
Saußele, Prof. Dr. med., Susanne
Tel: +49 (0)621 383-6966
Fax: +49 (0)621 383-4201
E-Mail: susanne.saussele@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
E-Mail: dietger@medizin.uni-leipzig.de

Kurzprotokoll Kurzprotokoll
Anmerkung 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.
erstellt 24.09.2014 Hanna Ebert
geändert 14.11.2016 Eva-Maria Ableidinger
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