WT1 Peptide Vaccination in Acute Myeloid Leukemia (AML)
Phase 2
- Conditions
- Acute Myeloid LeukemiaMyelodysplastic Syndrome
- Registration Number
- NCT00153582
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
In this trial, HLA-A2+ patients with active AML are vaccinated with a peptide from the leukemia-associated antigen WT1 together with immunological adjuvants keyhole limpet hemocyanin (KLH) as T-helper protein and granulocyte macrophage colony stimulating factor (GM-CSF) 4 times bi-weekly, then monthly.
- Detailed Description
In this phase II trial HLA-A2+ patients with active AML without curative treatment option are vaccinated with WT1 126-134 peptide mixed with adjuvant KLH as T-helper protein and GM-CSF 4 times bi-weekly, then monthly.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- AML or myelodysplastic syndromes (MDS)
- Partial response (PR) or complete response (CR) or smoldering course without option for allogeneic stem cell transplantation
- HLA-A2+
- WT1-expression in bone marrow
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Generation of T cell response
- Secondary Outcome Measures
Name Time Method Clinical outcome Safety
Trial Locations
- Locations (1)
Hematology&Oncology Charité CBF
🇩🇪Berlin, Germany