UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin (RIC version) Phase I
Title of the study (Brief title)	Post-haploSCT CY protocol (RIC version)
Region	Japan

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

Objectives
Narrative objectives1	To optimize the dose of ATG-G in haploidentical HSCT using posttransplant CY in combination with RIC
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Day 60 survival with engraftment without grade III-IV acute GVHD
Key secondary outcomes	(1) 1-year OS and PFS (2) 1-year NRM (3) graft failure (4) time to engraftment and complete donor chimerism (5) acute/chronic GVHD (6) regimen-related toxicity (CTCAE ver 4.0) (7) relapse (8) infection (bacterial, fungal, viral) (9) immune reconstitution

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	Medicine
Interventions/Control_1	Haploidentical HSCT with a RIC regimen using posttransplant CY as GVHD prophylaxis
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	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) high-risk hematological malignancy (2) patients who do not have an HLA matched related donor or unrelated donor (3) patients who have an HLA haploidentical related donor (4) Age: >=18, <=65 years old (5) ECOG PS 0 or 1 (6) patients with informed consent (7) patients who are expected to survival at least 3 months (8) patients who are ineligible for a myeloablative conditioning regimen
Key exclusion criteria	(1) severe organ dysfunction (2) uncontrolled hypertenstion (3) HIV (4) uncontrolled active infection (5) uncontrolled CNS disease (6) pregnant (7) uncontrolled mental disorder (8) allergy to drugs used as conditioning regimen or GVHD prophylaxis (9) recent high-dose chemotherapy (10) patients whom the physician regard as inappropriate for this study
Target sample size	12

Research contact person
Name of lead principal investigator	Shigeo Fuji
Organization	National Cancer Center Hospital
Division name	Hematopoietic Cell Transplantation Division
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	sfuji@ncc.go.jp

Public contact
Name of contact person	Shigeo Fuji
Organization	National Cancer Center Hospital
Division name	Hematopoietic Cell Transplantation Division
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	sfuji@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	MHLW(Japan)
Organization
Division
Category of Funding Organization
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	国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 19 Day
Anticipated trial start date	2013 Year 06 Month 20 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	2013 Year 06 Month 19 Day
Last modified on	2018 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012877