Therapeutic Efficacy of Wilms Tumor Gene (WT1) mRNA-electroporated Autologous Dendritic Cell Vaccination in Patients With Myeloid Malignancies and Multiple Myeloma: A Phase II Trial
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.