A phase I/II study of a WT1-W10 immunotherapy against high-risk MDS and MDS overt AML.
Phase 1
- Conditions
- High-risk MDS and MDS overt AM
- Registration Number
- JPRN-UMIN000026023
- Lead Sponsor
- Department of Hematology and respiratory Medicine, School of Medicine, Kochi University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1)patients with infectious diseases including active Tuberculosis which are poorly controlled. 2)patients with serious comorbidities (generally those with grade 3 or higher by the NCI-CTC criteria ver 3.0) 3)pregnant women, Breast feeding mothers 4)patients with severe mental problems. 5)patients who have already been recruited in other clinical trials. 6)Patients who have dropped out after starting this clinical trials.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I : adverse events of grade 3 or higher, all adverse events by the CTCAE criteria Phase II : progression free survival
- Secondary Outcome Measures
Name Time Method Recurrence rate, survival rate, overall survival, maximal response, specific immune responses