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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029196
Receipt No. R000032634
Scientific Title TM5614 IN COMBINATION WITH TYROSINE KINASE INHIBITORS IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN MAJOR MOLECULAR RESPONSE WITHOUT ACHIEVING A DEEP MOLECULAR RESPONSE.
Date of disclosure of the study information 2017/09/19
Last modified on 2018/09/21

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Basic information
Public title TM5614 IN COMBINATION WITH TYROSINE KINASE INHIBITORS IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN MAJOR MOLECULAR RESPONSE WITHOUT ACHIEVING A DEEP MOLECULAR RESPONSE.
Acronym Phase 2 study of TM5614
Scientific Title TM5614 IN COMBINATION WITH TYROSINE KINASE INHIBITORS IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN MAJOR MOLECULAR RESPONSE WITHOUT ACHIEVING A DEEP MOLECULAR RESPONSE.
Scientific Title:Acronym Phase 2 study of TM5614
Region
Japan

Condition
Condition Chronic myelogenous leukaemia in chronic phase
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To determine the efficacy of TM5614 in combination with TKI (imatinib, nilotinib, or bosutinib) potentially able to produce a 25% increase in the Cumulative Incidence of DMR by 12 weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The cumulative incidence of patients achieving DMR defined by MR4.5 or deeper (BCR-ABLIS below 0.0032 %) by 12 weeks
Key secondary outcomes The transition of BCR-ABLIS in 12 weeks

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TM5614 (120mg, once a day after breakfast for 4 weeks)
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. Patient aged 18y or more
2. Signed informed consent
3. Patient with chronic phase CML and Major BCR-ABL1 transcript positivity
4. Treatment with tyrosine kinase inhibitors (TKIs) for more than 2 years overall
5. No switch between TKIs within the last 12 weeks
6. No dose modification of TKI within the last 12 weeks
7. BCR-ABLIS below 0.1%
8. BCR-ABLIS above 0.0032%
9. ECOG grade 0 to 2
10. AST and ALT below 2.5 N
11. Bilirubin in serum below 2.5 N
12. Men and Women of childbearing potential must be using an adequate method of contraception
Key exclusion criteria 1. Pregnant or lactating women
2. Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment
3. Prior history of hematopoietic stem cell transplantation (autologous or allogenic)
4. Cardiovascular disease:
- Stage II to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure
- Myocardial infarction within the previous 6 months
- Symptomatic cardiac arrhythmia requiring treatment
- QTc above 480msec
5. Known T315I BCR-ABL kinase domain mutation
6. Patients who take Dasatinib within the last 12 weeks
7. Patients who start to take pioglitazone within the last 12 weeks
8. CML patient not in chronic phase at diagnosis
9. Individuals with an active malignancy
10. Known HIV-positivity
11. Individuals with bleeding tendency
12. Other patients whom a lead investigator or the patient's primary physician deems are not appropriate for this study
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Harigae
Organization Tohoku University Hospital
Division name Hematology and Rheumatology
Zip code
Address 1-1 Seiryomachi Sendai Aoba-ku, Miyagi, Japan
TEL 022-717-7000
Email harigae@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Harigae
Organization Tohoku University Hospital
Division name Hematology and Rheumatology
Zip code
Address 1-1 Seiryomachi Sendai Aoba-ku, Miyagi, Japan
TEL 022-717-7000
Homepage URL
Email harigae@med.tohoku.ac.jp

Sponsor
Institute Tohoku university school of medicine, molecular medicine and therapy
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 19 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 08 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 19 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 19 Day
Last modified on
2018 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032634

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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