Acute Myeloid Leukemia, Myelodysplastic Syndrome
Conditions
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.
Interventions
BIOLOGICALWT1 126-134 peptide
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Generation of T cell response | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcome | — |
| Safety | — |
Countries
Germany
Contacts
Primary ContactCarmen Scheibenbogen, MD
Outcome results
None listed