UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of CMV specific CTL generated from third party for treatment of antiviral drug-resistant CMV infection after allogeneic stem cell transplantation
Title of the study (Brief title)	Phase I study of CMV specific CTL generated from third party for treatment of antiviral drug-resistant CMV infection after allogeneic stem cell transplantation
Region	Japan

Condition
Condition	Antiviral drug-resistant CMV infection 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 CMV specific CTL generated from third party for the treatment of antiviral drug-resistant CMV infection 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 CMV reactivation (quantitative PCR and CMV antigenemia) and CMV specific CTL in peripheral blood Clinical course of CMV 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 CMV 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. After allogeneic hematopoietic stem cell transplantation 2. HLA-A0201/0206 or HLA-A2402 3. Antiviral drug (ganciclovir, valgancyclovir, foscarnet)-resistant CMV infection or CMV infection with difficulty in administering antiviral drugs. 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 CMV) 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	Hitoshi Kiyoi
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Hematology and Oncology
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL	052-744-2141
Email	kiyoi@med.nagoya-u.ac.jp

Public contact
Name of contact person	Tetsuya Nishida
Organization	Nagoya University Hospital
Division name	Hematology
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL	052-744-2145
Homepage URL
Email	tnishida@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine, Department of Hematology and Oncology
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)

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 10 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 10 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 28 Day
Last modified on	2018 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018055