UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Posttransplant Vorinostat therapy for the prevention of early relapse after allogeneic stem cell transplantation against mycosis fungoides/Sezary syndrome
Title of the study (Brief title)	Posttransplant Vorinostat therapy against mycosis fungoides/Sezary syndrome
Region	Japan

Condition
Condition	mycosis fungoides/Sezary syndrome
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To validate the safty of Vorinostat therapy after allogeneic stem cell tansplantation against more than Stage IIB of mycosis fungoides/Sezary syndrome
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	More than grade 4 (NCI-CTCAE version 4.0) of non-hematological toxicity within day 180 after allogeneic stem cell transplantation
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	100mg of Vorinostat is added from day 28 posttransplantation. If the adverse effect etc is permissive in initial 2 weeks, the dose of Vorinostat is increased up to 200mg thereafter. Vorinostat is continued until day 180.
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	All patients must have more than Stage IIB of mycosis fungoides/Sezary syndrome (1)Patients who have an appropriate related or unrelated donor described in the protocol. (2)From 16 to 65 years old (3)ECOG performance status of 0, 1 or 2 (4)Good major organ functions (lung, kidney, liver, heart) (5)Suitable to receive a reduced intensity transplant regimen in this trial (6)Patients who agree with this trial by informed consent form (in cases under age, getting agreement also by (legal) representative)
Key exclusion criteria	(1)Diabetes uncontrollable (2)Uncontrollable hypertension. (3)Current active infection. (4)Hepatitis B virus antigen (HBsAg), Hepatitis C virus RNA, or HIV antibody- positive. (5)Current active cancer. (6)Pregnant or nursing women or women who may be pregnant. (7)Uncontrollable mental illness. (8)Other unsuitable reasons
Target sample size	6

Research contact person
Name of lead principal investigator	Souichi Shiratori
Organization	Hokkaido university hospital
Division name	Department of Hematology
Address	Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-7214
Email	s.shiratori@med.hokudai.ac.jp

Public contact
Name of contact person	Souichi Shiratori
Organization	Hokkaido university hospital
Division name	Department of Hematology
Address	Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-7214
Homepage URL
Email	s.shiratori@med.hokudai.ac.jp

Sponsor
Institute	North Japan Hematology Study Group
Institute
Department

Funding Source
Organization	North Japan Hematology Study Group
Organization
Division
Category of Funding Organization	Other
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	2013 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 19 Day
Anticipated trial start date	2013 Year 06 Month 01 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 05 Month 21 Day
Last modified on	2016 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012563