WT1 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with WT1-specific TCR gene"

UMIN ID: UMIN000017431

Registered date:06/05/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Acute myelogeous lekemia, Myelodysplastic syndrome
• Date of first enrollment: 2015/05/07
• Target sample size: 9
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): subcutaneous injection of WT1 peptide, 300microgram mixed with Montanide ISA-51 VG

Outcome(s)

• Primary Outcome: Safety Immune reaction

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 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

Related Information

• Primary Sponsor: Mie University Graduate School of Medicine
• Source(s) of Monetary Support: Mie University