Overview

This trial is active, not recruiting.

Condition leukemia, myelogenous, chronic, breakpoint cluster region-abelson proto-oncogene (bcr-abl) positive
Treatments bosutinib, imatinib
Phase phase 3
Targets PDGF, BCR-ABL, KIT, SRC
Sponsor Avillion Development 1 Limited
Start date June 2014
End date August 2016
Trial size 530 participants
Trial identifier NCT02130557, AV001

Summary

Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Bosutinib, 400 mg, oral administration once a day
bosutinib
(Active Comparator)
Imatinib, 400 mg, oral administration once a day
imatinib

Primary Outcomes

Measure
The 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

Secondary Outcomes

Measure
The proportion of participants with MMR at 18 Months in the bosutinib treatment group with the imatinib treatment group
time frame: 18 Months
The duration of MMR in the bosutinib treatment group with the imatinib treatment group
time frame: 5 Years
The proportion of participants with Complete Cytogenetic Response (CCyR) by 12 Months in both treatment groups
time frame: 12 Months
The duration of CCyR in both treatment groups
time frame: 5 Years

Eligibility Criteria

Male or female participants at least 18 years old.

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, which are permitted for up to 6 months prior to study entry (signature of ICF) if suitably approved for use in the subject's region. 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, cirrhosis or evidence of decompensated liver disease. Patients with resolved Hepatitis B can be included. 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 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.

Additional Information

Official 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)
Description 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 approximately 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 approximately 5 years (240 weeks) after randomization.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Avillion Development 1 Limited.
Location data was received from the National Cancer Institute and was last updated in April 2016.