UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Allogeneic hematopoietic stem cell transpalntation using Thymoglobulin for patients with T-cell malignancy
Title of the study (Brief title)	AlloHSCT with ATG for T-cell malignancy
Region	Japan

Condition
Condition	T-cell malignancy
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety of allogeneic HSCT using Thymoglobulin against T-cell malignancy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Probability of survival with engraftment at 60 days after allogeneic HSCT
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	Medicine
Interventions/Control_1	Conditioning regimen using Thymoglobulin
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) HSCT using a HLA matched related donor, or HLA at least 6/8 matched unrelated donor (2) T-cell malignancy, including B-cell lymphoma expressing T cell marker (3) Disease status no complete remission (4) 18<=age<=70 (5) ECOG PS 0 or 1 (6) informed consent (7) those who are expected to survive at least 3 months
Key exclusion criteria	(1) severe organ failure (2) uncontrolled hypertension (3) HIV infection (4) uncontrolled active infection (5) uncontrolled CNS invasion (6) pregnancy (7) psychological disorder (8) allergy to drugs used in this study (9) if the physician consider as inappropriate
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	MHLW
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

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 01 Day
Anticipated trial start date	2014 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	2014 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=R000018313