UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Hideo Harigae
Organization	Tohoku University Hospital
Division name	Hematology and Rheumatology
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	Hideo Harigae
Organization	Tohoku University Hospital
Division name	Hematology and Rheumatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032634