|- candidate number||20828|
|- NTR Number||NTR4868|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-okt-2014|
|- Secondary IDs||NCT02130557 NL48355.029.14|
|- Public 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)|
|- 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)|
|- ACRONYM||BFORE study|
|- hypothesis||To compare proportion of participants with Major Molecular Response (MMR) at 12 Months in the bosutinib arm with that of the imatinib arm|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||1. Molecular diagnosis of CP CML of < 6 months (from initial diagnosis) |
2. Adequate hepatic, renal and pancreatic function
3. Age > 18 years
|- Exclusion criteria||1. Any prior medical treatment for CML, including tyrosine kinase inhibitors (TKIs), with the exception of hydroxyurea and/or anagrelide treatment.|
2. Any past or current Central Nervous System (CNS) involvement, including leptomeningeal leukemia.
3. Extramedullary disease only.
4. Major surgery or radiotherapy within 14 days of randomization.
5. History of clinically significant or uncontrolled cardiac disease.
6. Known seropositivity to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface-antigen positive), hepatitis C or evidence of decompensated liver disease or cirrhosis.
7. Recent or ongoing clinically significant GI disorder, e.g. Crohn's Disease, Ulcerative Colitis, or prior total or partial gastrectomy.
8. History of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.
9. Current, or recent (within 6 months), participation in other clinical trials.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2014|
|- planned closingdate||1-aug-2016|
|- Target number of participants||530|
|- Interventions||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||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||• 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.
|- Timepoints||12 Months|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.J.W.M. Janssen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.J.W.M. Janssen|
|- Sponsor/Initiator ||Avillion LLP|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||29-okt-2014 - 26-nov-2014|