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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015634
Receipt No. R000018170
Scientific Title Phase I study of EBV specific CTL generated from third party for treatment of EBV associated lymphoproliferative disorder after allogeneic stem cell transplantation
Date of disclosure of the study information 2014/11/07
Last modified on 2017/11/09

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Basic information
Public title Phase I study of EBV specific CTL generated from third party for treatment of EBV associated lymphoproliferative disorder after allogeneic stem cell transplantation
Acronym EBV specific CTL for treatment of EBV associated LPD after stem cell transplant
Scientific Title Phase I study of EBV specific CTL generated from third party for treatment of EBV associated lymphoproliferative disorder after allogeneic stem cell transplantation
Scientific Title:Acronym EBV specific CTL for treatment of EBV associated LPD after stem cell transplant
Region
Japan

Condition
Condition EBV associated lymphoproliferative disorder after allogeneic stem cell transplantation
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of EBV specific CTL generated from third party for the treatment of EBV associated lymphoproliferative disorder after allogeneic stem cell transplantation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Incidence of adverse events and graft-versus-host disease
Key secondary outcomes Monitoring of EBV viral load and EBV specific CTL in peripheral blood
Clinical course of EBV infection

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
Maneuver
Interventions/Control_1 Administration of EBV specific CTL induced and expanded from donor peripheral blood of third party
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 1. Prior allogeneic hematopoietic stem cell transplantation
2. HLA-A0201/0206, HLA-A2402 or HLA-1101
3. Rituximab resistant, difficulty in administering rituximab or CD20 negative EBV associated lymphoproliferative disorder
4. Written informed consent from patient or legal representative
5. Fulfill all of the following criteria:
Performance status 0-3, GOT /GPT =<10 x upper normal limit (UNL), total bilirubin =<3 x UNL,
serum creatinine =<3 x UNL, SpO2>=90% (room air)
Key exclusion criteria 1. Severe or uncontrollable bacterial, fungal,and viral (except EBV) infection
2. Uncontrollable GVHD
3. Uncontrollable heart failure
4. Psychoses
5.History of allergic reaction to albumin
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Takahashi
Organization Nagoya University Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL 052-744-2942
Email ytakaha@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiro Nishio
Organization Nagoya University Hospital
Division name Center for Advanced Medicine and Clinical Research
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL 052-744-2942
Homepage URL
Email nnishio@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine,
Department of Pediatrics
Institute
Department

Funding Source
Organization Nagoya University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 07 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 Open public recruiting
Date of protocol fixation
2014 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 10 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 11 Month 07 Day
Last modified on
2017 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018170

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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