Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
Conditions
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 treatme
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
Sponsors
Avillion Development 1 Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Molecular diagnosis of CP CML of 18 years
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • 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. | — |
Contacts
Public ContactJ.J.W.M. Janssen
VU University Medical Center De Boelelaan 1117
Outcome results
None listed