acute myeloid leukemia
Conditions
Interventions
4 intradermal vaccinations with autologous dendritic cells loaded with mRNA coding for the WT1 protein.
Sponsors
Antwerp University Hospital, Antwerp, Belgium
Eligibility
Inclusion criteria
Inclusion criteria: 1. Tumor type: Acute Myeloid Leukemia (AML) according to the WHO criteria (ea at least 20% blasts in the marrow). This % should be assessed on a BM aspiration or, in case of dry tap, on a BM biopsy. All FAB subtypes except M3. Patients with Myelodysplastic Syndrome, category of Refractory Anemia with Excess Blasts (RAEB): RAEB I (WHO: medullary blast count ¡Ü 10% and a peripheral blast count ¡Ü 5%) and RAEB II (WHO: medullary blast count > 10% and/or > 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities. 2. Extent of disease: remission (partial or complete) or smouldering course. Complete remission (CR) is defined as no blasts in the peripheral blood and no more than 5% blasts in the bone marrow. This definition is related to the hematological remission if it is not specified. Partial remission (PR) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate. Smouldering course is defined as a relatively low marrow blast count and slowly progressive disease. WBC count at registration 1 copy of WT1 per 1000 copies ABL) in peripheral blood as assessed by quantitative RT-PCR at the time of diagnosis. 4. Prior treatments: Patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment and/or 6 months past allogeneic/autologous stem cell transplantation. 5. Age: ¡Ý 18 years. 6. Performance status: WHO PS grade 0-1 (Appendix B); 7. Objectively assessable parameters of life expectancy: more than 3 months; 8. Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV; 9. No concomitant use of immunosuppressive drugs; 10. Adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal; 11. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; 12. Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation.
Exclusion criteria
Exclusion criteria: 1. Subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix); 2. Subjects who are pregnant; 3. Subjects who have sensitivity to drugs that provide local anesthesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of multiple DC injections. Assessment of acute toxicity and/or auto-immunity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection of WT1-specific T cell immunity by: 1. IFN-gamma ELISPOT; 2. WT1 Tetramer analysis (if patient is HLA*A0201 positive); 3. DTH skin test; Clinical response as evidenced by decreased WT1 RNA levels in peripheral blood measured by quantitative RT-PCR. | — |
Contacts
Public ContactZwi Berneman
Antwerp University Hospital, Department of Hematology Wilrijkstraat 10,
Outcome results
None listed