Pediatric hematological malignancy
Conditions
Interventions
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.
Sponsors
Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Evaluation by NCI-CTCAE ver 4.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy 2. Immune responses to WT1 | — |
Countries
Japan
Contacts
Public ContactYoshiko Hashii
Osaka University Graduate School of Medicine Pediatrics
Outcome results
None listed