Phase 1 study of WT1 peptide vaccine therapy for high risk leukemia patients after hematopoietic stem cell transplantation

UMIN ID: UMIN000002089

Registered date:18/06/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute myeloid leukemia, Acute lymphoblastic leukemia, Chronic myeloid leukemia blastic phase, Myelodysplastic syndrome with high risk of relapse and/or excess blasts
• Date of first enrollment: 2009/02/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): WT1 peptide vaccine

Outcome(s)

• Primary Outcome: Safety and the immunological optimal dose of WT1 vaccine.
• Secondary Outcome: Efficacy, Over all survival, Progression free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients with any one of the criteria are ineligible. 1. Patients with active acute GVHD or extended chronic GVHD (including bronchiolitis obliterans or bronchiolitis obliterans organizing pneumonia). 2. Patients receiving over permitted dose of immunosuppressive drugs or corticosteroids . 3. Patients with active infection including positive cytomegalovirus antigenemia which requires treatment. 4. Patients with positive HBs antigen, or HCV antibody. Patients with active hepatitis or cirrhosis. 5. Pregnant or breast feeding patients. Patients who have a possibility of pregnancy or desire for baby. 6. Patients with active autoimmune disease (including hypothyroidism, idiopathic thrombocytopenic purpura, autoimmune hepatitis) or with a history of those diseases. 7. Patients with active interstitial pneumonia or its history. 8. Patients with a history of allergy or severe adverse reaction against biological agents. 9. Patients with a severe psychological disorder and considered unable to obtain informed consent for the study. 10. Patients with uncontrollable central nervous invasion. 11. Patients participating in other clinical trials*. * If the safety and anti-tumor effect of vaccine therapy is obviously not considered to be affected by the other clinical trials, the patient doesn't need to be excluded. 12. Patients who are considered ineligible for the study.

Related Information

• Primary Sponsor: National Cancer Research Center Hospital
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare