Unique ID issued by UMIN | UMIN000019421 |
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Receipt number | 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 13:25:48 |
Short term tapering of Ruxolitinib prior conditioning therapy with allogeneic stem cell transplantation for primary myelofibrosis
Short term tapering of Ruxolitinib prior allo-SCT for primary MF
Short term tapering of Ruxolitinib prior conditioning therapy with allogeneic stem cell transplantation for primary myelofibrosis
Short term tapering of Ruxolitinib prior allo-SCT for primary MF
Japan |
Primary myelofibrosis
Hematology and clinical oncology |
Malignancy
NO
To confirm the safety of short term tapering of Ruxolitinib prior conditioning therapy with allogeneic stem cell transplantation for primary myelofibrosis
Safety
Confirmatory
Not applicable
1.Engraftment and survival at 4 weeks after allo-SCT
2.Analysis of cytokine and growth factor during Allo-SCt
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
6 days taparing off of Ruxolitinib prior conditioning therapy with allogeneic stem cell transplantation
20 | years-old | <= |
70 | years-old | >= |
Male and Female
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
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
2
1st name | |
Middle name | |
Last name | Shiratori Souichi |
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Department of Hematology
Kita-14 Nishi-5, Kita-ku, Sapporo, Hokkaido, Japan
011-706-7214
s.shiratori@med.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Shiratori Souichi |
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Department of Hematology
Kita-14 Nishi-5, Kita-ku, Sapporo, Hokkaido, Japan
011-706-7214
s.shiratori@med.hokudai.ac.jp
Department of Internal Medicine, Hakodate Municipal Hospital, Hakodate, Japan
Hakodate Municipal Hospital, Hakodate, Japan
Other
NO
2015 | Year | 10 | Month | 20 | Day |
Unpublished
Completed
2015 | Year | 07 | Month | 01 | Day |
2015 | Year | 08 | Month | 20 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 05 | Month | 13 | Day |
2015 | Year | 10 | Month | 20 | Day |
2017 | Year | 10 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022464
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