UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024634
Receipt No. R000026429
Scientific Title Multi-virus (Cytomegalovirus, EB virus, Adenovirus, BK virus, and HHV-6) specific Cytotoxic T-Lymphocytes from HLA-haploidentical or more HLA-matched relative donor to persistent viral infection after hematopoietic cell transplantation (multi-center, prospective phase I/II study)
Date of disclosure of the study information 2016/11/01
Last modified on 2018/07/24

* 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 Multi-virus (Cytomegalovirus, EB virus, Adenovirus, BK virus, and HHV-6) specific Cytotoxic T-Lymphocytes from HLA-haploidentical or more HLA-matched relative donor to persistent viral infection after hematopoietic cell transplantation (multi-center, prospective phase I/II study)
Acronym Multi-virus specific CTL from HLA-haploidentical or more HLA-matched relative donor to persistent viral infection after HCT.
Scientific Title Multi-virus (Cytomegalovirus, EB virus, Adenovirus, BK virus, and HHV-6) specific Cytotoxic T-Lymphocytes from HLA-haploidentical or more HLA-matched relative donor to persistent viral infection after hematopoietic cell transplantation (multi-center, prospective phase I/II study)
Scientific Title:Acronym Multi-virus specific CTL from HLA-haploidentical or more HLA-matched relative donor to persistent viral infection after HCT.
Region
Japan

Condition
Condition Persistent viral infection after Hematopoietic cell transplanation
Classification by specialty
Hematology and clinical oncology Adult Child
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the feasibility, safety and efficacy of multi-virus (Cytomegalovirus, EB virus, Adenovirus, BK virus, and HHV-6) specific Cytotoxic T-Lymphocytes from HLA--haploidentical or more matched related donor to persistent viral infection after hematopoietic cell transplantation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Adverse event rate (during the 30 days after the final intervention, >=CTCAev4.0 Grade3)
Acute GVHD (Grade III-IV) rate (during the 45 days after the final intervention)


Key secondary outcomes 1) Determination of recommended cell dose of transfusion
2) Chronic GVHD rate (during the 1 year after the final intervention)
3) Improvement of clinical symptoms and reduction rate of viral load(during the 30 days after the final intervention)
4) Count of Virus-specific T-cells(at 2, 4, 12 weeks after the intervention)
5) Improvement of clinical symptoms (at 6 and 12 weeks after the final intervention)
6) Overall survival rate (at 6 months and 12 months after the final intervention)


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
Other
Interventions/Control_1 Multi-virus specific CTL to persistent viral infection after hematopoietic 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 Inclusion criteria for case

1)Time post hematopoietic cell transplantation is between 30 days and 36 months.
2)Refractory to standard anti-viral therapies for ADV, BKV, CMV, EBV, HHV6
3)Acute GVHD is grade II and under or chronic GVHD is moderate and under, with steroid (prednisolone) less than 0.5mg/kg/day
4)Obtained informed consent from a patient (20 years old and over) and/or a guardian of the patient (under-20 years old).

Inclusion criteria for donor

1)Cognate parents or sibling or child with age between 10 and 69 years old
2)Related donor of allogenic hematopoietic cell transplantation for the recipient or HLA-haploidentical or more HLA-matched relative donor
3)Meeting the eligibility criterion for blood donation of Japanese Red Cross Society
4)Obtained informed consent from a patient (20 years old and over) and/or a guardian of the patient (under-20 years old) and inform assent (10 years old and over)
5)Not applicable for the following criteria
(1) Poor physical condition at the day of donation
(2) Dental therapy with bleeding within 3 days before the donation
(3) Cancer under treatment or within one year after treatment
(4) Hematological disorder
(5) Primary immunological disorder
(6) Collagen disease
(7) Autoimmune disorder
(8) Recipient of organ transplantation
(9) Carrier (or be suspected) for viruses such as HIV or hepatitis virus
(10) Creutzfeldt-Jakob disease (CJD) or suspected for CJD
(11) On immunosuppressant
(12) Piercing or tattooed within 6 months
Key exclusion criteria 1)ATG, Campath-1H or other anti-T cell monoclonal antibodies within 28 days before the entry.
2)Severe infectious diseases except for ADV, BKV, CMV, EBV, or HHV6 infection.
3)Donor lymphocyte infusion within 28 days before the entry
4)Uncontrollable acute GVHD (grade III-IV) despite standard immunosuppressive therapy (for example; prednisolone up to 0.5mg/kg/day)
5)Relapse of hematological malignancy that is considered as an indication for HSCT
6)History of malignancy, except for (1) the patients malignancy that is to be treated with HCT, (2) malignancy in remission for more than 5 years or (3) totally resected GI or skin cancer
7)Ejection fraction less than 40%
8)Patient judged not eligible for this study by the investigator.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro Morio
Organization Medical Hospital, Tokyo Medical and Dental University
Division name Department of Pediatrics
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5803-5249
Email tmorio.ped@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Morio
Organization Medical Hospital, Tokyo Medical and Dental University
Division name Department of Pediatrics
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5803-5249
Homepage URL
Email tmorio.ped@tmd.ac.jp

Sponsor
Institute Medical Hospital, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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 東京医科歯科大学医学部附属病院(東京)
東京大学医科学研究所附属病院(東京)

Other administrative information
Date of disclosure of the study information
2016 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2018 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 30 Day
Last modified on
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026429

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.