JPRN-UMIN000002089RecruitingPhase 1
Phase 1 study of WT1 peptide vaccine therapy for high risk leukemia patients after hematopoietic stem cell transplantation - WT1 vaccine for high risk leukemia after HSCT - Phase 1
ational Cancer Research Center Hospital0 sites18 target enrollmentStarted: June 18, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion 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.
Investigators
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