Efficacy of Dendritic Cell Therapy for Myeloid Leukemia and Myeloma

Inclusion Criteria:

• Acute Myeloid Leukemia (AML): all FAB subtypes except M3. Extent of disease:

  • clinical remission after at least one course of polychemotherapy
  • high risk of relapse due to age (> 60 years) or poor risk cytogenetic/molecular markers or hyperleukocytosis at presentation or previous relapse
• Chronic myeloid leukemia (CML): patients in chronic phase under therapy with tyrosinase kinase inhibitors who have sub-optimal response or failure and who are not eligible for hematopoietic stem cell transplantation.

• Multiple Myeloma (MM): symptomatic with active disease, independent of earlier and/or concomitant treatment:

  • Presence of serum/urine M protein (> 3 g/dl)
  • Bone marrow plasmacytosis (>10-30%)
  • Anemia, renal failure, hypercalcemia, and/or lytic bone lesions
• Overexpression of WT1 RNA in peripheral blood and or bone marrow as assessed by quantitative RT-PCR at the time of presentation.For CML: residual molecular disease as demonstrated by BCR-ABL RT-PCR
• Prior treatments: Patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment.
• Age: ≥ 18 years
• Performance status: WHO PS grade 0-1 (Appendix B)
• Objectively assessable parameters of life expectancy: more than 3 months
• Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV
• No concomitant use of immunosuppressive drugs
• adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
• 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
• Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

• Subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix)
• Subjects who are pregnant
• Subjects who have sensitivity to drugs that provide local anesthesia
• Subjects needing corticosteroids 1 mg/kg during vaccination; corticosteroids are allowed as part of their treatment when taken ≥ 30 days before the start of vaccination.