UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024634 |
|---|---|
| Receipt number | 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 | 2023/05/10 00:24:03 |
* 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 12 months.
2)Refractory to standard anti-viral therapies for ADV, BKV, CMV, EBV, HHV6
3)Acute GVHD is grade I 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).
5)No noninfectious pulmonary complications (NIPCs)
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)SpO2 on room air < 90%
8)Patients with any of the following pulmonary function tests (PFT) results:
i) FEV1/vital capacity < 70% for 16 years and older, and < 80% for age between 6 years and 15 years.
ii) %VC <80%
iii) FEV1 <75% of predicted with 10% decline compared before HCT.
9)Incidence of bronchiolitis obliterans (BO), or bronchiolitis obliterans syndrome (BOS) on high-resolution computed tomography.
10)KL-6 >500U/mL for patients 16 years and older, and >250U/mL for patients 15 years and under
11)Smoking after HSCT
12)Ejection fraction less than 40%
13)Patient judged not eligible for this study by the investigator.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Morio |
Organization
Medical Hospital, Tokyo Medical and Dental University
Division name
Department of Pediatrics
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5249
tmorio.ped@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Morio |
Organization
Medical Hospital, Tokyo Medical and Dental University
Division name
Department of Pediatrics
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5249
Homepage URL
tmorio.ped@tmd.ac.jp
Sponsor or person
Institute
Medical Hospital, Tokyo Medical and Dental University
Institute
Department
Personal name
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
Tokyo Medical and Dental University Certified Review Board
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, JAPAN
Tel
03-5803-5249
tiken.crc@tmd.ac.jp
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
3
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
| 2016 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 30 | 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
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026429
