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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014472
Receipt No. R000016837
Scientific Title Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin
Date of disclosure of the study information 2014/07/04
Last modified on 2014/07/03

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Basic information
Public title Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin
Acronym Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation
Scientific Title Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin
Scientific Title:Acronym Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation
Region
Japan

Condition
Condition Hematopoietic malignancy
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety of GVHD prophylaxis in Haploidentical hematopoietic stem cell transplantation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Engraftment and survival without grade III-IV acute GVHD at day60
Key secondary outcomes 1.1 year progression-free survival and overall survival
2.1 year non relapse mortarity
3.primary graft failure
4.secondary graft failure
5.acute and chronic GVHD

Base
Study type Interventional

Study design
Basic design Single arm
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 Conditioning regimen and GVHD prophylaxis
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
70 years-old >
Gender Male and Female
Key inclusion criteria patient with chemorefractory hematological malignancy, no HLA matched donner but HLA haploidentical donner
Key exclusion criteria Cases with a sufficient amount (2.0x106/kg CD34-positive cells) could not be harvested peripheral blood hematopoietic stem cells from donor
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Kohno
Organization Oita University Faculity of Medicine
Division name Department of Oncology and Hematology
Zip code
Address 1-1 Idaigaoka, Hasama, Yuhu-city, Oita, Japan
TEL 097-549-4411
Email kkohno@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Kohno
Organization Oita University Faculity of Medicine
Division name Department of Oncology and Hematology
Zip code
Address 1-1 Idaigaoka, Hasama, Yuhu-city, Oita, Japan
TEL 097-549-4411
Homepage URL
Email kkohno@oita-u.ac.jp

Sponsor
Institute Department of Oncology and Hematology, Oita University Faculity of Medicine
Institute
Department

Funding Source
Organization Department of Oncology and Hematology, Oita University Faculity of Medicine
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 大分大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 04 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
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 04 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
2014 Year 07 Month 03 Day
Last modified on
2014 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016837

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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