UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

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

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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　

Date of disclosure of the study information

2014

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

05

Month

26

Day

Last modified on

2016

Year

05

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015907