acute myeloid leukemia
Conditions
Interventions
Administer monocyte-derived dendritic cells intradermally every 2 weeks for 5 doses
Sponsors
Department of Hematology and Oncology, Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed as acute myeloid leukemia 2. More than 5 x 107 autologous leukemic cells have been stocked 3. Expression of WT1 in leukemic cells is confirmed by the following criteria 1) WT1 mRNA, more than 1,000 copy/microgram RNA for bone marrow 2) WT1 mRNA, more than 10 copy/microgram RNA for peripheral blood 4. Leukemic cells are detected after chemotherapy, based on the following criteria 1) 5% or more and less than 20% blasts on bone marrow smear 2) 0.1% or more and less than 20% leukemic cells on flow cytometry 3) WT1 mRNA, more than 1,000 copy/microgram RNA for bone marrow or more than 10 copy/microgram RNA for peripheral blood by real-time RT-PCR 4) pathologically diagnosed extramedullary lesions detected by physical examination of CT scan 5. Performance status (ECOG) 0-2 6. No chemotherapy has been performed within 4 weeks before informed consent 7. Meet the following criteria for organ functions 1) Serum creatinine less than 3 folds of the upper normal limit 2) Serum bilirubin less than 2.0 mg/dL 3) Serum AST/GOT less than 5 folds of the upper normal limit 4) Ejection fraction of cardiac left ventricle more than 40% by ultrasonography 5) Arterial oxygen saturation more than 93% in room air 8. Ineligible for hematopoietic stem cell transplantation, or the patient does not wish to receive it 9. Informed consent has been obtained
Exclusion criteria
Exclusion criteria: 1. There is deep seated active infection 2. There are other malignancies 3. There are leukemic lesions in the central nervous system 4. There is active autoimmune disease 5. Positive for HBs Ag, HCV Ab, HTLV-I Ab, HIV Ab, or serological test for syphilis 6. Responsible doctors judged the patient inappropriate for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity of NCI-CTC grade 1-4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Immunological monitoring 2. Complete remission rate 3. Partial remission rate | — |
Countries
Japan
Contacts
Public ContactNorimitsu Kadowaki
Kyoto University Hospital Department of Hematology and Oncology
Outcome results
None listed