UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of haploidentical hematopoietic stem-cell transplantation followed by post-transplant high-dose cyclophosphamide (RIC)
Acronym	Tsukuba-Haplo RIC
Scientific Title	Safety and efficacy of haploidentical hematopoietic stem-cell transplantation followed by post-transplant high-dose cyclophosphamide (RIC)
Scientific Title:Acronym	Tsukuba-Haplo RIC
Region	Japan

Condition
Condition	hematological malignancy
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the safety and efficacy of haploidentical hematopoietic stem-cell transplantation with reduced-intensity conditioning and post-transplant high-dose cyclophosphamide
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	disease-free survival on day 100
Key secondary outcomes	overall survival, nonrelapse mortality, GVHD and relapse.

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	HLA-haploidentical hematopoietic stem-cell transplantation post-transplant high-dose cyclophosphamide
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients with hematological malignancy 2) Patients 16 to 65 years of age 3) Patients who do not have HLA antigen-matched (6/6) appropriate related donors 4) Patients who do not have HLA allele-matched (8/8) unrelated donors. 5) Patients with ECOG of 0, 1, or 2 6) Patients without severe dysfunction in the heart, the lung, the liver, and the kidney 7) Patients who gave written informed consent
Key exclusion criteria	1) Patients with anti-HLA antibody 2) Patients with uncontrollable psychological complications 3) Patients with active double cancer 4) Patients with uncontrollable active infection 5) Pregnant women 6) Patients who are judged inappropriate by investigators
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Shigeru Middle name Last name Chiba
Organization	University of Tsukuba
Division name	Department of Hematology
Zip code	305-8575
Address	Tennodai 1-1-1, Tsukuba, Ibaraki
TEL	029-853-3127
Email	schiba-tky@umin.net

Public contact
Name of contact person	1st name Naoki Middle name Last name Kurita
Organization	University of Tsukuba
Division name	Department of Hematology
Zip code	305-8575
Address	Tennodai 1-1-1, Tsukuba, Ibaraki
TEL	029-853-3127
Homepage URL
Email	n-kurita@umin.ac.jp

Sponsor
Institute	University of Tsukuba, Department of Hematology
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	IRB, University of Tsukba
Address	Amakubo 2-1-1, Tsukuba, Ibaraki
Tel	029-853-3914
Email	chiken@un.tsukuba.ac.jp

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	2015 Year 01 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	10
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 12 Month 01 Day
Date of IRB	2014 Year 11 Month 17 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2019 Year 04 Month 20 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 11 Month 14 Day
Last modified on	2020 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018240