UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Short term tapering of Ruxolitinib prior conditioning therapy with allogeneic stem cell transplantation for primary myelofibrosis
Title of the study (Brief title)	Short term tapering of Ruxolitinib prior allo-SCT for primary MF
Region	Japan

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

Objectives
Narrative objectives1	To confirm the safety of short term tapering of Ruxolitinib prior conditioning therapy with allogeneic stem cell transplantation for primary myelofibrosis
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1.Engraftment and survival at 4 weeks after allo-SCT 2.Analysis of cytokine and growth factor during Allo-SCt
Key secondary outcomes	1.Survival at 12 weeks after allo-SCT 2.Disease status at 4 and 12 weeks after Allo-SCT 3.Acute GVHD 4.Infection 5.Adverse event (CTCAE ver.4 Grade3 or more) 6.Analysis of lymphocyte subsets and immunoglobulin at 4, 8 and 12 weeks after allo-SCT

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	6 days taparing off of Ruxolitinib prior conditioning therapy with allogeneic stem cell transplantation
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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1.More than Intermediate-2 (DIPSS plus) of primary myelofibrosis 2.HLA-A,-B,-DR antigen fullmatch or 1 locus mismatch related or unrelated donor 3.0 to 2 of ECOG performance status 4.More than 40% of Ejection Fraction in cardiac ultrasonography 5.More than 94% of SpO2 in room air 6.More than 70% of vital capacity and more than 70% of FEV1/FVC 7..Less than 2.0mg/dl of serum bilirubin and less than 5-fold ULN of AST 8.More than 40ml/min of eGFR
Key exclusion criteria	1.Positive of HBs antigen, HCV antibody, HIV antibody or HTLV-1 antibody 2.Uncontrollable psychiatric symptom 3.Pregnant woman or lactating 4.Active other cancers 5.Uncontrollable active infection 6.Hepatic cirrhosis 7.More than BMI 35 8.Others
Target sample size	2

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

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

Sponsor
Institute	Department of Internal Medicine, Hakodate Municipal Hospital, Hakodate, Japan
Institute
Department

Funding Source
Organization	Hakodate Municipal Hospital, Hakodate, Japan
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	2015 Year 10 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 08 Month 20 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 05 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 20 Day
Last modified on	2017 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022464