UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II trial to reveal safety and efficacy of TM5509 in allogeneic stem cell transplantation with TBI regimen
Title of the study (Brief title)	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	Makoto Onizuka
Organization	Tokai University School of Medicine
Division name	Hematology/ Oncology
Address	Shimokasuya143, Isehara, Kanagawa
TEL	0463-93-1121
Email	moni5@mac.com

Public contact
Name of contact person	Makoto Onizuka
Organization	Tokai University School of Medicine
Division name	Hematology/ Oncology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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