UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004904
Receipt No. R000005841
Scientific Title HLA haploidentical stem cell transplantation using myeloablative regimen including ATG
Date of disclosure of the study information 2011/01/20
Last modified on 2017/04/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title HLA haploidentical stem cell transplantation using myeloablative regimen including ATG
Acronym haplo-full with ATG
Scientific Title HLA haploidentical stem cell transplantation using myeloablative regimen including ATG
Scientific Title:Acronym haplo-full with ATG
Region
Japan

Condition
Condition hematologic malignancies
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and efficacy of haploidentical stem cell transplantation using myeloablative regimen including ATG
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes survival on day 100
Key secondary outcomes acute GVHD, complications, relapse 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 HLA haploidentical stem cell transplantation using myeloablative regimen including ATG
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
45 years-old >=
Gender Male and Female
Key inclusion criteria 1) Written informed consent.
2) Unavailability of HLA (A, B, DR)-matched or -one antigen mismatched-related donor.
3) Unavailability of HLA (A, B, DR)-matched or one allele of HLA-DRB1 mismatched-unrelated donor or needs urgent transplantation.
4) Availability of HLA 2-3 antigen mismatched related donor.
5) In case of hematologic malignancy in an advanced stage, patients could choose an HLA 2-3 antigen-mismatched donor, even if they have an HLA-matched or -1 antigen-mismatched donor.
6) Sufficient organ function
6-1) Ejection Fraction >= 50%
6-2) serum total billirubin is needed to be less than 2.5 times the normal upper limit
6-3) serum creatinine level <= 1.5* upper limit of institution
Key exclusion criteria 1) Allergy for the agents used in conditioning or GVHD prophylaxis
2) Patients who are considered as inappropriate with other reasons
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
2011 Year 01 Month 20 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
2011 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2016 Year 02 Month 01 Day
Date of closure to data entry
2016 Year 02 Month 01 Day
Date trial data considered complete
2016 Year 02 Month 01 Day
Date analysis concluded
2016 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 19 Day
Last modified on
2017 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005841

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.