UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study which assess the safety and efficiacy of haploidentical hematopoietic stem cell transplantation using posttransplant cyclophosphamide for adult T cell leukemia/lymphoma
Title of the study (Brief title)	Haplo for ATL
Region	Japan

Condition
Condition	aggressive adult T cell leukemia/lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess the safety and efficacy of haploidentical hematopoietic stem cell transplantation using posttransplantation cyclophosphamide and reduced-intensity conditioning regimen for ATL
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 hematopoietic stem cell transplantation using posttransplant cyclophosphamide for adult T cell leukemia/lymphoma
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients are considered eligible when all criteria are met (1) acute or lymphoma type (2) no HLA identical or HLA 1 locus-mismatched related or unrelated donor, or need urgent HSCT (3) HLA haploidentical related donor is available (4) age: 18-65 (5) ECOG PS 0 or 1 (6) disease status: CR, PR, SD (7) written consent is obtained (8) are expected to survive at least 3 months or longer
Key exclusion criteria	Patients who meet any criteria below are ineligible (1) severe organ failure (2) uncontrolled hypertension (3) HIV infection (4) uncontrolled infection (5) uncontrolled CNS invasion (6) pregnant/lactating (7) psychological disorder (8) known allergy for drugs used as GVHD prophylaxis or conditioning regimen (9) history of administration of anti-CCR4 antibody (10) high titer of anti-donor specific HLA antibody (11) the physician considers inappropriate for this study
Target sample size	17

Research contact person
Name of lead principal investigator	Takahiro Fukuda
Organization	National Cancer Center Hospital
Division name	Department of hematopoietic stem cell transplantation
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	tafukuda@ncc.go.jp

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

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	AMED
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 05 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 12 Month 22 Day
Anticipated trial start date	2016 Year 04 Month 05 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	2016 Year 04 Month 05 Day
Last modified on	2016 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025124