UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018191 |
|---|---|
| Receipt number | 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 21:24:37 |
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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
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
moni5@mac.com
Sponsor or person
Institute
Tohoku University School of Medicine, Molecular Medicine and Therapy, Toshio Miyata
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021049
