UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Allogeneic stem cell transplantation from HLA completely mismatched family donor for posttransplant relapse
Title of the study (Brief title)	HLA comlpetely mismatched HSCT
Region	Japan

Condition
Condition	hematologic malignancies relapesd after allogeneic stem cell transplantation
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	to evaluate the safety and efficacy of stem cell transplantation from HLA fully mismatched family donor for hematologic malignancies relapsed after allogeneic transplantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Rate of donor cell engraftment (>90% of donor origin) on day 35
Key secondary outcomes	a) Incidence and severity of chronic GVHD b) transplantion-associated complications, especially TMA c) relapse rate within three months

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	HSCT from HLA fully mismatched family donor
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	cases with hematologic malignancies relapsed after allogeneic stem cell transplantation who fulfill the following (patient and spousal donor), [patient] 1) Written informed consent 2) no expectancy of cure with standard therapies including DLI [family donor] 1) healthy family member who desires to become the donor 2) no available or suitable donor in unrelate bank, cord blood bank, haploidentical relatives (confirmed by our conference) 3) If there is an aveilable spousal donor, the patient and the family can participate either in this protocol or in spousal transplantation protocol (spousal hematopoietic stem cell transplantation for posttransplant relapse UMIN000004132).
Key exclusion criteria	1) Cre > 2.0 mg/dl 2) EF < 40% 3) T-Bil > 2.0 mg/dl 4) AST and/or ALT > 200 U/L 5) SpO2 < 90% (room air) 6) PS (ECOG score) 3-4 Patients with these data due to original diseases are not excluded.
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroyasu Ogawa
Organization	Hyogo College of Medicine
Division name	Division of Hematology, Department of Internal Medicine
Address	1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL	+81-798-45-6886
Email	haplo@hyo-med.ac.jp

Public contact
Name of contact person	Kazuhiro Ikegame
Organization	Hyogo College of Medicine
Division name	Division of Hematology, Department of Internal Medicine
Address	1-1, Mukogawa-cho, Nishinomiya city, Hyogo
TEL	0798-45-6886
Homepage URL
Email	kame@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	兵庫医科大学　血液内科

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 05 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2016 Year 12 Month 01 Day
Date of closure to data entry	2016 Year 12 Month 01 Day
Date trial data considered complete	2016 Year 12 Month 01 Day
Date analysis concluded	2016 Year 12 Month 01 Day

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

Management information
Registered date	2012 Year 06 Month 07 Day
Last modified on	2016 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009554