UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cell immunotherapy infusing HLA-haploidentical lymphocytes from a family member of non-HSCT donor
Title of the study (Brief title)	HLA-haploidentical lymphocyte infusion from a family member of non-HSCT donor
Region	Japan

Condition
Condition	Relapsed malignancies or refractory viral diseases after allogeneic hematopoietic stem cell transplantation
Classification by specialty	Hematology and clinical oncology Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Verification of safety and efficacy of lymphocyte infusion
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maximum tolerable dose of T-cell infusion
Key secondary outcomes

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	Other
Interventions/Control_1	Cell immunotherapy
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	20 years-old >
Gender	Male and Female
Key inclusion criteria	1. Fulfilling the criteria mentioned above. 2. Written consent was obtained.
Key exclusion criteria	1. Acute GVHD Grade II or above. 2. Extensive chronic GVHD. 3. Physician's decision.
Target sample size	15

Research contact person
Name of lead principal investigator	Masami Inoue
Organization	Osaka medical center and research institute for maternal and child health
Division name	Hematology/Oncology
Address	840 Murodo, Izumi City, Osaka 594-1101, Japan
TEL	0725-56-1220
Email	pedino@mch.pref.osaka.jp

Public contact
Name of contact person	Akihisa Sawada
Organization	Osaka medical center and research institute for maternal and child health
Division name	Hematology/Oncology
Address	840 Murodo, Izumi City, Osaka 594-1101, Japan
TEL	0725-56-1220
Homepage URL
Email	asawada@mch.pref.osaka.jp

Sponsor
Institute	Osaka Women's and Children's Hospital
Institute
Department

Funding Source
Organization	Advanced Clinical Research Organization (ACRO)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 12 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 07 Month 23 Day
Anticipated trial start date	2013 Year 07 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 11 Day
Last modified on	2018 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016558