Unique ID issued by UMIN | UMIN000014054 |
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Receipt number | R000016364 |
Scientific Title | Safety test of long-term administration of WT1 peptide-based immunotherapy for pediatric patients after stem cell transplantation |
Date of disclosure of the study information | 2014/07/09 |
Last modified on | 2014/05/23 19:59:27 |
Safety test of long-term administration of WT1 peptide-based immunotherapy for pediatric patients after stem cell transplantation
Safety test of long-term administration of WT1 peptide-based immunotherapy for pediatric patients after stem cell
Safety test of long-term administration of WT1 peptide-based immunotherapy for pediatric patients after stem cell transplantation
Safety test of long-term administration of WT1 peptide-based immunotherapy for pediatric patients after stem cell
Japan |
Pediatric hematological malignancy
Pediatrics |
Malignancy
YES
Evaluation of safety and antitumor effects on long-term administration of WT1 peptide vaccination
Safety
Phase I
Safety
Evaluation by NCI-CTCAE ver 4.0
1. Efficacy
2. Immune responses to WT1
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
The patient is intradermally injected with the WT1 peptide emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was scheduled to be performed every two or four weeks.
0 | years-old | <= |
20 | years-old | >= |
Male and Female
1 HLA-A2402 and or A0201 positive
2 Judged as having clinical effects due to previous WT1 vaccine
3 Meet the following criteria for organ functions
4 Neutrophil more than 1,000/microliter, Platelet more than 25,000/microliter, Hemoglobin more than 6.5g/dl
1 HLA-A2402 and or A0201 positive
2 Judged as having clinical effects due to previous WT1 vaccine
3 Meet the following criteria for organ functions
4 Neutrophil more than 1,000/microliter, Platelet more than 25,000/microliter, Hemoglobin more than 6.5g/dl
5 Serum creatinine less than age-specific normal level 3 times
6 Serum bilirubin less than less than age-specific normal level 2 times
7 Serum AST/GOT less than 4 folds of the upper normal limit
8 Arterial oxygen saturation more than 95% in room air
9 Age 0-20
10 Performance status (ECOG) 0-2
11 Informed consent has been obtained
12 No severe GVHD
13 in CCR
1. There is deep-seated active infection.
2. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis. Patients who have complications that are considered inappropriate for the trial.
3. Responsible doctors judged the patient inappropriate for the trial
12
1st name | |
Middle name | |
Last name | Takako Miyamura |
Osaka University Graduate School of Medicine
Pediatrics
2-2, Yamada-oka, Suita-city, Osaka, Japan
06-6879-3932
miyamur@ped.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshiko Hashii |
Osaka University Graduate School of Medicine
Pediatrics
2-2, Yamada-oka, Suita-city, Osaka, Japan
06-6879-3932
yhashii@ped.med.osaka-u.ac.jp
Osaka University Graduate School of Medicine
Ministry of Education, Culture, Sports, Science and Technology
NO
2014 | Year | 07 | Month | 09 | Day |
Unpublished
Preinitiation
2014 | Year | 07 | Month | 01 | Day |
2014 | Year | 08 | Month | 01 | Day |
2014 | Year | 05 | Month | 23 | Day |
2014 | Year | 05 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016364
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