UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001749 |
|---|---|
| Receipt number | 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 21:10:43 |
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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
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
ytakaha@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics,
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002105
