EUCTR2009-015720-28-BE进行中（未招募）不适用
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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 = 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.)
- •Chronic myeloid leukemia (CML): patients in chronic phase under therapy with tyrosinase kinase inhibitors who have sub-optimal response or failure according to the European Leukemianet guidelines (Baccarani et al. Blood 2006) and who are not eligible for hematopoietic stem cell transplantation
- •Multiple Myeloma (MM): symptomatic with active disease:
- •o Presence of serum/urine M protein (> 3 g/dl)
- •o Bone marrow plasmacytosis (>10-30%)
- •o Anemia, renal failure, hypercalcemia, and/or lytic bone lesions
- •2. Extent of disease:
- •i. clinical remission after at least one course of polychemotherapy
- •ii. high risk of relapse defined as (and/or):
- •1. Age > 60 years (if <60 y, no sibling allotransplant donor available)
- •2. Poor risk cytogenetic or molecular markers
- •3. Hyperleukocytosis at presentation
- •4. Previous relapse
- •i. Chronic phase and
- •ii. Not eligible for allogenic stem cell transplantation and
- •iii. sub-optimal response or failure towards tyrosine kinase inhibitors
- •iv. or toxicity
- •c. MM: symptomatic with active disease, independent of earlier and/or
- •concommitant treatment
- •3. Overexpression of WT1 RNA in peripheral blood and or bone marrow as assessed by quantitative RT-PCR at the time of presentation.
- •4. For CML: residual molecular disease as demonstrated by BCR-ABL RT-PCR
- •5. Prior treatments: Patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment.
- •6. Age: = 18 years
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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. 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.
研究者
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