UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010774 |
|---|---|
| Receipt number | R000012563 |
| Scientific Title | Posttransplant Vorinostat therapy for the prevention of early relapse after allogeneic stem cell transplantation against mycosis fungoides/Sezary syndrome |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2016/11/22 13:16:46 |
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Basic information
Public title
Posttransplant Vorinostat therapy for the prevention of early relapse after allogeneic stem cell transplantation against mycosis fungoides/Sezary syndrome
Acronym
Posttransplant Vorinostat therapy against mycosis fungoides/Sezary syndrome
Scientific Title
Posttransplant Vorinostat therapy for the prevention of early relapse after allogeneic stem cell transplantation against mycosis fungoides/Sezary syndrome
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Souichi Shiratori |
Organization
Hokkaido university hospital
Division name
Department of Hematology
Zip code
Address
Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7214
s.shiratori@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Souichi Shiratori |
Organization
Hokkaido university hospital
Division name
Department of Hematology
Zip code
Address
Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-7214
Homepage URL
s.shiratori@med.hokudai.ac.jp
Sponsor or person
Institute
North Japan Hematology Study Group
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 19 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012563
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
