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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019421
Receipt No. R000022464
Scientific Title Short term tapering of Ruxolitinib prior conditioning therapy with allogeneic stem cell transplantation for primary myelofibrosis
Date of disclosure of the study information 2015/10/20
Last modified on 2017/10/21

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Basic information
Public title Short term tapering of Ruxolitinib prior conditioning therapy with allogeneic stem cell transplantation for primary myelofibrosis
Acronym Short term tapering of Ruxolitinib prior allo-SCT for primary MF
Scientific Title Short term tapering of Ruxolitinib prior conditioning therapy with allogeneic stem cell transplantation for primary myelofibrosis
Scientific Title:Acronym 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
1st name
Middle name
Last name Shiratori Souichi
Organization Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Division name Department of Hematology
Zip code
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
1st name
Middle name
Last name Shiratori Souichi
Organization Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Division name Department of Hematology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2015 Year 07 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000022464

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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