UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029196 |
|---|---|
| Receipt number | 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 10:41:54 |
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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
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
harigae@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university school of medicine, molecular medicine and therapy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032634
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