UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032282 |
|---|---|
| Receipt number | 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 | 2024/03/29 15:12:03 |
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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
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
shkimu@cc.saga-u.ac.jp
Sponsor or person
Institute
Division of Hematology, Respiratory diseases and Oncology, Faculty of Medicine, Saga University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 22 | Day |
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
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036813
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