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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014073
Receipt No. R000015907
Scientific Title Foscarnet therapy (90 mg/kg) to prevent HHV-6 encephalitis in umbilical cord blood transplant recipients
Date of disclosure of the study information 2014/06/01
Last modified on 2016/05/26

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Basic information
Public title Foscarnet therapy (90 mg/kg) to prevent HHV-6 encephalitis in umbilical cord blood transplant recipients
Acronym Foscarnet to prevent HHV-6 encephalitis for CBT recipients
Scientific Title Foscarnet therapy (90 mg/kg) to prevent HHV-6 encephalitis in umbilical cord blood transplant recipients
Scientific Title:Acronym Foscarnet to prevent HHV-6 encephalitis for CBT recipients
Region
Japan

Condition
Condition The patients 16 years or older who receive umbilical cord blood transplant as the first allogeneic hematopoietic cell transplantation for the treatment of hematologic malignancies (blood cancers) .
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For patients who receive cord blood transplantation for the treatment of hematologic malignancies, foscarnet (90 mg/kg/day) is administrated for 21 days to prevent the development of HHV-6 encephalitis. Efficacy and safety are evaluated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Cumulative incidence of plasma HHV-6 DNA>=10,000 copies/ml at 60 days after transplantation.
Key secondary outcomes 1. Safety
2. Incidence of HHV-6 encephalitis and possible HHV-6 encephalitis within 60 days after transplantation
3. Overall survival at 60 days after transplantation
4. Cumulative incidence of non-repapse mortality, relapse, acute GVHD
5. Relationship between HHV-6 reactivation and administration period of foscarnet
6. Incidence of plasma HHV-6 DNA>=10,000 copies/ml in patients who complete 21 days administration of foscarnet.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Foscarnet administration
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who receive umbilical cord blood transplantation as the first allogeneic stem cell transplantation for the treatment of hematologic malignancies (blood cancers).
2. Patient 16 years or older.
3. Written informed consent. If patient is less than 20 years, written informed consent from both patient and patient's parent/guardian is required.
Key exclusion criteria 1. Patient who have allergy against foscarnet.
2. Patient whose creatinine clearance <0.8 mL/min/kg
3. Patient who is judged as inappropriate to participate this study by any reasons. Medical doctor participating this study make this decision.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Ogata
Organization Oita University Faculty of Medicine
Division name Department of Medical Oncology and Hematology
Zip code
Address Hasama-machi, Yufu-city, Oita, Japan
TEL 097-586-6275
Email mogata@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Kurihara
Organization Non-profit organization Japan Clinical research Support Unit
Division name Research support section for Pediatrics/Hematology
Zip code
Address Yujima 1-10-5, Bunkyo-ku, Tokyo, Japan
TEL 03-5297-6258
Homepage URL
Email Info@crsu.org

Sponsor
Institute Research team to establish the efficacy of allogeneic stem cell transplantation for adult T cell leukemia, and optimize the treatment based on genome analysis.
JSHCT
Institute
Department

Funding Source
Organization research team to establish the efficacy of allogeneic stem cell transplantation for the treatment of adult T cell leukemia, and optimize the treatment based on genome analysis
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
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 国立がん研究センター中央病院、大分大学病院、長野赤十字病院、新潟大学附属病院、北海道大学附属病院、大分県立病院、神戸大学附属病院、松下記念病院、大阪赤十字病院、佐賀大学附属病院、済生会前橋病院 

Other administrative information
Date of disclosure of the study information
2014 Year 06 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
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
2014 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 15 Day
Last follow-up date
2016 Year 05 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 26 Day
Last modified on
2016 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015907

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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