UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin Phase I study
Title of the study (Brief title)	Post-CY haploHSCT with ATG (MAC)
Region	Japan

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

Objectives
Narrative objectives1	To determine the dose of ATG-G in combination with posttransplant cyclophosphamide for haploidentical hematopoietic stem cell transplantation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Day 60 engraftment and survival without grade III-IV acute GVHD
Key secondary outcomes	(1) 1-year OS and PFS (2) 1-year NRM (3) graft failure (4) engraftment rate (5) acute and chronic GVHD (6) regimen-related toxicity (CTCAE ver 4.0) (7) relapse rate (8) infectious disease (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	Conditioning regimen and GVHD prophylaxis for allogeneic HSCT
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	55 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) High risk hematological malignancy including AML, ALL, CML, HL, NHL, MDS (2) Those who do not have HLA-matched or 1-locus mismatched related donor/unrelated donor (3) Those who have HLA-haploidentical related donor (4) Age >=18, <=55 (5) ECOG PS 0 or 1 (6) Those who agree to the participation (7) Those who are expected to survive longer than 3 months
Key exclusion criteria	(1) Organ dysfunction (2) Uncontrolled hypertension (3) HIV positive (4) Uncontrolled active infection (5) Uncontrolled CNS invasion (6) Pregnant (7) Psychiatric disorder (8) Allergy to drugs used for HSCT (9) Other reason which physicians think the patient is inappropriate for the study
Target sample size	15

Research contact person
Name of lead principal investigator	Shigeo Fuji
Organization	National Cancer Center Hospital
Division name	Division of Hematopoietic Stem Cell Transplantation
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	Division of Hematopoietic Stem Cell Transplantation
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	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	東京都中央区築地5-1-1

Other administrative information
Date of disclosure of the study information	2012 Year 11 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 21 Day
Anticipated trial start date	2012 Year 11 Month 21 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	2012 Year 11 Month 21 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=R000011010