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

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 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


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

Value
https://center6.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