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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000030647
Date of registration:	31/12/2017
Prospective Registration:	No
Primary sponsor:	National Center for Child Health and Development
Public title:	Reduced intensity conditioning allogeneic stem cell transplantation with dose-adjusted busulfan and anti-thymocyte globulin for chronic granulomatous disease: a multicenter phase II trial (CGD-RIST2)
Scientific title:	Reduced intensity conditioning allogeneic stem cell transplantation with dose-adjusted busulfan and anti-thymocyte globulin for chronic granulomatous disease: a multicenter phase II trial (CGD-RIST2) - A phase II study of RIC-SCT for CGD
Date of first enrolment:	2017/12/30
Target sample size:	22
Recruitment status:	Recruiting
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034992
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Motohiro Kato
Address:	2-10-1, Okura, Setagaya, Tokyo Japan
Telephone:	03-3416-1811
Email:	kato-mt@ncchd.go.jp
Affiliation:	National Center for Child Health and Development Children's Cancer Center

Name:	Motohiro Kato
Address:	2-10-1, Okura, Setagaya, Tokyo Japan
Telephone:	03-3416-1811
Email:	kato-mt@ncchd.go.jp
Affiliation:	National Center for Child Health and Development Children's Cancer Center

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1. Intracranial hemorrhage 2. Severe psychological disorders 3. Pregnant or suspected pregnancy 4. Not eligible for this study at the discretion of the investigator.

Age minimum: Not applicable
Age maximum: 25years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Chronic granulomatous disease

Intervention(s)

Conditioning regimen with targeted-busulfan and fludarabin Total body irradiation (3Gy) at day -1 Stem cell transplantation at day 0

Primary Outcome(s)

Event free survival at day 100

Secondary Outcome(s)

1. Engraftment probability at day 30 2. Mortality at day 100 3. Incidence of infectious disease at week 8 4. Reconstruction of immune status 5. Time from transplantation to onset of acute GVHD 6. Reconstruction of neutrophil function

Secondary ID(s)

Source(s) of Monetary Support

National Center for Child Health and Development

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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