Unique ID issued by UMIN | UMIN000017431 |
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Receipt number | R000013659 |
Scientific Title | WT1 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with WT1-specific TCR gene" |
Date of disclosure of the study information | 2015/05/06 |
Last modified on | 2016/11/05 09:55:57 |
WT1 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with WT1-specific TCR gene"
WT1 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with WT1-specific TCR gene"
WT1 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with WT1-specific TCR gene"
WT1 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with WT1-specific TCR gene"
Japan |
Acute myelogeous lekemia, Myelodysplastic syndrome
Hematology and clinical oncology |
Malignancy
NO
To evaluate the safety and the immune reaction in the peptide vaccinated patients who have completed "adoptive transfer of lymphocytes transduced with WT1-specific TCR gene"
Safety
Safety
Immune reaction
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Vaccine |
subcutaneous injection of WT1 peptide, 300microgram mixed with Montanide ISA-51 VG
20 | years-old | <= |
Not applicable |
Male and Female
1.Patient who completed "adoptive transfer of lymphocytes transduced with WT1-specific TCR gene(UMIN000011519)"
2.adverse events whith grade 1 or 2 during the above study
3.Performance status(ECOG) 0 to 1
4.Having written informed consent
1.Having following serious complications
# Uncontrolled anigina pectoris, myocardial infarction, or heart failure
# Uncontrolled diabetes mellitus or hytertention
# Uncontrolled infection
# X-ray-proven interstitial pneumonia or pulmonary fibrosis
# Autoimmune disease
# Bleeding tendency; PT less than 50%, APTT more than 60sec, serum fibrinogen less than 100mg/dL, FDP more than 20ug/mL
Thrombosis tendency
2.History of serious hypersensitivity
3.Unctrolled pleural effusion, ascites, or pericardial effusion
4.Uncontrolled CNS metastasis
5.Systemic corticostoroid or immuno-suppressive therapy
6. Inappropriate for WT1 peptide administration, i.e. allergic to the peptide or adjuvant
7.Mental illness or drug dependency affecting informed consent
8.Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner, except having cryopreseved sperm
9. Lasting less than four weeks from the previous enrollment to clinical trials
11.Inappropriate for study entry judged by an attending physician
9
1st name | |
Middle name | |
Last name | Shinichi Kageyama |
Mie University Graduate School of Medicine
Immuno-Gene Therapy
2-174, Edobashi, Tsu, Mie 514-8507 Japan
059-231-5380
kageyama@clin.medic.mie-u.ac.jp
1st name | |
Middle name | |
Last name | Shinichi Kageyama |
Mie University Graduate School of Medicine
Immuno-Gene Therapy
2-174, Edobashi, Tsu, Mie 514-8507 Japan
059-231-5380
kageyama@clin.medic.mie-u.ac.jp
Mie University Graduate School of Medicine
Mie University
Other
NO
三重大学医学部附属病院
2015 | Year | 05 | Month | 06 | Day |
Unpublished
Terminated
2013 | Year | 09 | Month | 10 | Day |
2015 | Year | 05 | Month | 07 | Day |
2015 | Year | 05 | Month | 06 | Day |
2016 | Year | 11 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013659
Research Plan | |
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