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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018191
Receipt No. R000021049
Scientific Title A phase II trial to reveal safety and efficacy of TM5509 in allogeneic stem cell transplantation with TBI regimen
Date of disclosure of the study information 2015/07/10
Last modified on 2016/11/28

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Basic information
Public title A phase II trial to reveal safety and efficacy of TM5509 in allogeneic stem cell transplantation with TBI regimen
Acronym TM5509-5
Scientific Title A phase II trial to reveal safety and efficacy of TM5509 in allogeneic stem cell transplantation with TBI regimen
Scientific Title:Acronym TM5509-5
Region
Japan

Condition
Condition Hematologic Malignancy
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether TM5509 reduces toxicity of irradiation or promotes engraftment after bone marrow transplantation with TBI (total body irradiation) regimen.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 1) OAG (oral assessment guide) score until engraftment
2) Engraftment rate at day14
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design expanded access
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 TM5509 60mg/day for 7 days
TM5509 120mg/day for 7 days
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
20 years-old <=
Age-upper limit
55 years-old >=
Gender Male and Female
Key inclusion criteria (1) Conditioning regimen; CY+TBI12Gy
(2) Allogeneic stem cell transplantation
(3) Expectation of life for 3 months
(4) Without bleeding disease at starting conditioning regimen
(5) HCT-CI less than 6
(6) PS (ECOG) 0 or 1
(7) From 20 to 55 year-old
(8) Patient written consent by themselves is given before starting conditioning regimen
Key exclusion criteria (1) History of ICH
(2) Un-controrable infection
(3) Un-controrable hypertension
(4) Known active chronic hepatitis B (HBs Ag+) or C (HCV Ab+)
(5) Liver disfunction; T-Bil, AST, ALT, gGTP or ALP > 2x upper limit of normal range
(6) Renal failure; GFR less than 50ml/min
(7) Sever complication with cardiovascular, pulmonary or gastrointestinal system
(8) Plural of cancer
(9) Under using Pentostatin
(10) Known allergy against Cyclophosphamide, Mesna, other thiol-compounds, Dexamethasone or Methylprednisolone or Granisetron.
(11) Male patients who do not agree with contraception during the study period.
(12) Candidate mother, lactation or hope for pregnancy while the study period
(13) Patient who had registered and medicated in the other clinical trial within 12 weeks before consent.
(14) Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Onizuka
Organization Tokai University School of Medicine
Division name Hematology/ Oncology
Zip code
Address Shimokasuya143, Isehara, Kanagawa
TEL 0463-93-1121
Email moni5@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Onizuka
Organization Tokai University School of Medicine
Division name Hematology/ Oncology
Zip code
Address Shimokasuya143, Isehara, Kanagawa
TEL 0463-93-1121
Homepage URL
Email moni5@mac.com

Sponsor
Institute Tohoku University School of Medicine, Molecular Medicine and Therapy, Toshio Miyata
Institute
Department

Funding Source
Organization MHLW (Japan)
Organization
Division
Category of Funding Organization
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 東海大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 10 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
2015 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 04 Day
Last modified on
2016 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021049

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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