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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004132
Receipt No. R000004962
Scientific Title spousal hematopoietic stem cell transplantation for posttransplant relapse
Date of disclosure of the study information 2010/09/01
Last modified on 2016/08/08

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Basic information
Public title spousal hematopoietic stem cell transplantation for posttransplant relapse
Acronym spousal hematopoietic stem cell transplantation
Scientific Title spousal hematopoietic stem cell transplantation for posttransplant relapse
Scientific Title:Acronym spousal hematopoietic stem cell transplantation
Region
Japan

Condition
Condition hematologic malignancies relapesd after allogeneic stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 to evaluate the safety and efficacy of spousal stem cell transplantation for hematologic malignancies relapsed after allogeneic transplantation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Rate of donor cell engraftment (>90% of donor origin) on day 35
Key secondary outcomes a) Incidence and severity of chronic GVHD
b) transplantion-associated complications, especially TMA
c) relapse rate
within three months

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 spousal stem cell transplantation
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria cases with hematologic malignancies relapsed after allogeneic stem cell transplantation who fulfill the following (patient and spousal donor),
[patient]
1) Written informed consent
2) no expectancy of cure with standard therapies including DLI
[spousal donor]
1) healthy spouse who desires to become the donor
2) within HLA three antigen mismatch in GVH direction
3) no available or suitable donor in unrelate bank, cord blood bank, haploidentical relatives (confirmed by our conference)
Key exclusion criteria 1) Cre > 2.0 mg/dl
2) EF < 40%
3) T-Bil > 2.0 mg/dl
4) AST and/or ALT > 200 U/L
5) SpO2 < 90% (room air)
6) PS (ECOG score) 3-4
Patients with these data due to original diseases are not excluded.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Ogawa
Organization Hyogo College of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL 0798-45-6886
Email haplo@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Ikegame
Organization Hyogo College of Medicine
Division name Division of Hematology, Department of Internal Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL 0798-45-6886
Homepage URL
Email kame@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 兵庫医科大学 血液内科

Other administrative information
Date of disclosure of the study information
2010 Year 09 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 Completed
Date of protocol fixation
2008 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2016 Year 12 Month 01 Day
Date of closure to data entry
2016 Year 12 Month 01 Day
Date trial data considered complete
2016 Year 12 Month 01 Day
Date analysis concluded
2016 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 30 Day
Last modified on
2016 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004962

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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