Dendritic Cell Vaccination for Patients With Acute Myeloid Leukemia in Remission (CCRG 05-001)

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring AML in remission Read More

Inclusion Criteria:

1. Tumor type: Acute Myeloid Leukemia (AML) according to the WHO criteria (ea at least 20% blasts in the marrow). All FAB subtypes except M3. Patients with Myelodysplastic Syndrome, category of Refractory Anemia with Excess Blasts (RAEB): RAEB I (WHO: medullary blast count ≤ 10% and a peripheral blast count ≤ 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.
3. Overexpression of WT1 RNA (>50 copies of WT1 per 1000 copies ABL in bone marrow or >2 copy/1000 copies ABL in peripheral blood) as assessed by quantitative RT-PCR at the time of presentation.
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: ≥ 18 years

6. High risk of relapse because of (and/or)

   • Age > 60 years (if <60 y, no sibling allotransplant donor available)
   • Poor risk cytogenetic or molecular markers at presentation
   • Hyperleukocytosis at presentation
   • Second complete remission after relapse
7. Performance status: WHO PS grade 0-1 (Appendix B)
8. Objectively assessable parameters of life expectancy: more than 3 months
9. Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV
10. No concomitant use of immunosuppressive drugs
11. Adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
12. 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
13. Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation

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
4. Age < 18 years