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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001749
Receipt No. R000002105
Scientific Title Phase I study of CMV specific CTL for treatment of refractory CMV infection after allogeneic hematopoietic stem cell transplantation
Date of disclosure of the study information 2009/03/03
Last modified on 2013/08/08

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Basic information
Public title Phase I study of CMV specific CTL for treatment of refractory CMV infection after allogeneic hematopoietic stem cell transplantation
Acronym Phase I study of CMV specific CTL for treatment of refractory CMV infection after allogeneic hematopoietic stem cell transplantation
Scientific Title Phase I study of CMV specific CTL for treatment of refractory CMV infection after allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym Phase I study of CMV specific CTL for treatment of refractory CMV infection after allogeneic hematopoietic stem cell transplantation
Region
Japan

Condition
Condition Refractory CMV infection after allogeneic hematopoietic 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 for the treatment of refractory CMV infection after allogeneic hematopoietic stem cell transplantation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Adverse events
Key secondary outcomes Monitoring of CMV reactivation (quantitative PCR and CMV antigenemia) and CMV specific CTL in peripheral blood

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
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. CMV infection resistant to ganciclovir and/or foscarnet after allogeneic hematopoietic stem cell transplantation
2. Fulfill all of the following criteria: Performance status 0-3, GOT /GPT =< 20 x upper normal limit, total bilirubin < 6 mg/dl, serum creatinine =< 3 x upper normal limit, PaO2 >= 60mmHg, PaCO2 =< 60mmHg, No evidence of heart failure, Ejection Fraction >= 50%
3. Written informed consent from patient or person in parental authority
4. donor peripheral blood available


Key exclusion criteria 1. Severe or uncontrollable bacterial, fungal, and viral (except CMV) infection
2. Uncontrollable acute and chronic GVHD
3. Psychoses
4. History of allergic reaction to albumin
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Kojima
Organization Nagoya University Graduate School of Medcine
Division name Department of Pediatrics
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Takahashi
Organization Nagoya University Graduate School of Medcine
Division name Department of Pediatrics
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
Homepage URL
Email ytakaha@med.nagoya-u.ac.jp

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

Funding Source
Organization Department of Pediatrics,
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Hematology and Oncology,
Nagoya University Graduate School of Medicine
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
2009 Year 03 Month 03 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
2008 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 03 Day
Last modified on
2013 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002105

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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