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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028779
Receipt No. R000032937
Scientific Title Phase I/II study of HSCT from HLA-matched donor using post-transplant cyclophosphamide
Date of disclosure of the study information 2017/11/01
Last modified on 2017/08/22

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Basic information
Public title Phase I/II study of HSCT from HLA-matched donor using post-transplant cyclophosphamide
Acronym Tsukuba PTCY for MRD/MUD
Scientific Title Phase I/II study of HSCT from HLA-matched donor using post-transplant cyclophosphamide
Scientific Title:Acronym Tsukuba PTCY for MRD/MUD
Region
Japan

Condition
Condition AML, ALL, NHL. MDS
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy of HSCT from MRD/MUD using post-transplant cyclophosphamide
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Success rate at 6 months.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 50 mg/kg of cyclophosphamide on day 3, 4
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
16 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1) AML, ALL, NHL, MDS
2) age 16-60
3) PS =< 2
4) EF >= 40%
5) SpO2 >= 90%
6) Bil =< 2.0 mg/dl
7) Ccr >= 30 ml/min
Key exclusion criteria 1) positive for HBs Ag
2) positive for HIV Ag
3) depression
4) pregnancy
5) coexisting active cancer
6) active infection
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chigeru Chiba
Organization University of Tsukuba
Division name Department of Hematology, Faculty of Medicine
Zip code
Address 1-1-1, Tennodai, Tsukuba, Ibaraki
TEL 029-853-3127
Email schiba-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Kurita
Organization University of Tsukuba
Division name Department of Hematology, Faculty of Medicine
Zip code
Address 1-1-1, Tennodai, Tsukuba, Ibaraki
TEL 029-853-3127
Homepage URL
Email kuripon@mvb.biglobe.ne.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba Hospital
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 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
2017 Year 08 Month 22 Day
Last modified on
2017 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032937

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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