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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032282
Receipt No. R000036813
Scientific Title A phase 2 study of BOsutinib Gradual Increase as a second or third line treatment for chronic myeloid leukemia in chronic phase
Date of disclosure of the study information 2018/04/18
Last modified on 2018/04/17

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Basic information
Public title A phase 2 study of BOsutinib Gradual Increase as a second or third line treatment for chronic myeloid leukemia in chronic phase
Acronym BOGI Trial
Scientific Title A phase 2 study of BOsutinib Gradual Increase as a second or third line treatment for chronic myeloid leukemia in chronic phase
Scientific Title:Acronym BOGI Trial
Region
Japan

Condition
Condition chronic myeloid leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 When the standard dose of bosutinib of 500mg QD is used as second or third line treatment for chronic myeloid leukemia in chronic phase (CML-CP) patients who have showed resistance or intolerance to prior ABL tyrosine kinase inhibitors (TKIs), severe diarrhea or liver failure occurs highly frequently, often requiring a dose interruption or discontinuation of treatment. We herein investigate whether gradual increase of bosutinib after starting at a low dose (200mg QD) can lower the dose interruption or discontinuation of treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Bosutinib treatment drop-out rate due to AEs by 12 months after initiation of bosutinib

Key secondary outcomes 1.Rate of treatment interruptions

2.Mean bosutinib doses at 12 months after initiation of bosutinib

3.Administration period of bosutinib and its median dose intensity/relative dose intensity up to 12 months after initiation of bosutinib

4.Cumulative complete cytogenetic response (CCyR) maintenance rate at 6 and 12 months after initiation of bosutinib

5.Cumulative major molecular response (MMR) rate and cumulative deep molecular response (DMR rate) at 3, 6, 9 and 12 months after initiation of bosutinib

6.Incidence of all grades or grade 3 or 4 adverse events (AE)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral bosutinib is introduced at 200mg QD for the initial dose. If all AEs are more than grade 2, the dose is gradually titrated by 100mg/day every two weeks. If any AEs are less than grade 3, the administration is suspended until the relevant AE returns to more than grade 1 and once it does, the administration is restarted from the decreased dose. If any of the AEs are more than grade 3 at the initial dose of 200mg QD, the administration will restart at the same dose when the AE lowers to less than grade 1. When all AEs are maintained at more than grade 2, it is titrated again by 100mg/day every two weeks. This method of titration is continued until the daily dose reaches 500mg. When the same more than grade 3 AE is observed for two consecutive administrations at the same dose, a decreased dose is given for treatment as the maintenance dose. If the patient cannot take more than 300mg QD 3 months after initiation of bosutinib, this protocol is terminated. Furthermore, the protocol is terminated if a more than grade 3 AE cannot be improved to less than grade 1 for more than four weeks despite withdrawal, and is switched to method of treatment other than bosutinib.If it is judged as fail based on European LeukemiaNet diagnosis criteria at 3, 6 and 12 months after starting treatment, this protocol is terminated and the treatment is switched to something other than bosutinib.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients of major BCR-ABL-positive CML-CP

2)Patients aged 18 or above at the time of pre-enrollment

3)Patients who exhibited resistance or intolerance to 1 or 2 other TKI

4)Patients with ECOG performance status 0-2

5)Patients whose function of the principal organs (liver, kidneys lungs) are maintained according to criteria by each institution

6)Patients whose written consent was obtained (the consent of parents or guardians required in the case of minors)
Key exclusion criteria 1)Patients who have history of taking anti-cancer drugs other than hydroxyurea for CML

2)Patients who are newly diagnosed CML

3)Patients who have progress to AP or BP

4)Patients with severe or uncontrollable complications

5)Patients with complications of inflammatory bowel disease

6)Pregnant and breastfeeding women, patients who wish to get pregnant within 12 months

7)Patients who are participating in another clinical trial

8)Patients with known T315I or V299L mutation

9)Concomitant medications known to be strong inducers or inhibitors of P450 isoenzyme CYP3A4

10)Known HIV and/or active viral hepatitis (hepatitis B or C)

11)Impaired cardiac function, including any of the following:
a. History of or presence of complete left bundle branch block, right bundle branch block plus left anterior hemiblock, bifascicular block in screening ECG
b. ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads in screening ECG
c. Congenital long QT syndrome
d. QTc > 450 msec in the screening ECG
e. QT-prolonging concomitant medication
f. History of or presence of significant ventricular or atrial tachyarrhythmias in screening ECG
g. Myocardial infarction within 6 months prior to inclusion
h. Unstable angina diagnosed or treated during the past 12 months
i. uncontrolled hypertension, history of labile hypertension
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Kimura
Organization Faculty of Medicine, Saga University
Division name Hematology, Respiratory Medicine and Oncology
Zip code
Address 5-1-1, Nabeshima, 849-8501 Saga, Japan
TEL 81-(0)952-34-2366
Email shkimu@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Kimura
Organization Faculty of Medicine, Saga University
Division name Hematology, Respiratory Medicine and Oncology
Zip code
Address 5-1-1, Nabeshima, 849-8501 Saga, Japan
TEL 81-(0)952-34-2366
Homepage URL
Email shkimu@cc.saga-u.ac.jp

Sponsor
Institute Division of Hematology, Respiratory diseases and Oncology, Faculty of Medicine, Saga University
Institute
Department

Funding Source
Organization Pfizer. Co. Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Faculty of Medicine, Akita University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 佐賀大学医学部附属病院、秋田大学医学部附属病院、福島県立医科大学附属病院、広島大学附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 18 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 06 Month 01 Day
Date trial data considered complete
2020 Year 06 Month 01 Day
Date analysis concluded
2020 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 17 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036813

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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