2024-515292-35-00暂停2 期
Wilms’ tumor (WT1) antigen-targeted dendritic cell vaccination to prevent relapse in adult patients with acute myeloid leukemia: a multicenter randomized phase II trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Primary end point: Overall survival
研究概览
简要总结
Clinical response: To determine the clinical efficacy of WT1 mRNA-electroporated DC vaccination as a post-remission strategy to prevent relapse and prolong overall survival in adult AML patients
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO): A) All French-American-British (FAB) subtypes (except for M3 (acute promyelocytic leukemia)) B) All cases of de novo AML or secondary AML with ≥20 % blasts in peripheral blood and/or bone marrow (except for AML secondary to myeloproliferative neoplasms (MPN) and AML secondary to exposure of leukemogenic agents (therapy-related (t)-AML) unless treated with CPX-351 chemotherapy or hypomethylating agents combined with venetoclax)
- •Adult (≥18 years) at very high risk of relapse according to A) Age ≥60 years, and/or B) Adverse biological features (e.g. adverse cytogenetics, adverse morphological features, adverse molecular features, hyperleukocytosis (>100000 cells/µL)), and C) Ineligible for or unwilling to receive hematopoietic stem cell transplantation
- •Completion of one of the following treatment options: I) Intensive chemotherapy: [(1) At least one cycle of induction chemotherapy and one cycle of consolidation chemotherapy (low-dose cytarabine as consolidation therapy is allowed) OR (2) One to two cycles of CPX-351 induction treatment and up to two cycles of CPX-351 consolidation treatment] OR II) Low-intensity chemotherapy: [(3) At least two cycles to maximum six cycles of hypomethylating agents (HMA) whether or not combined with venetoclax (VEN) OR (4) At least two cycles to maximum six cycles of low-dose cytarabine (LDAC) combined with venetoclax]; resulting in: A) Morphological complete remission (CR) (i.e. bone marrow blast count <5% with neutrophil count >1000 cells/µL and platelet count >100,000 cells/µL) OR B) Morphological complete remission with incomplete blood recovery (CRi) (i.e. bone marrow blast count <5% with neutrophil count <1000 cells/µL or platelet count <100,000 cells/µL. For the purpose of this study protocol, platelet count must be >50,000 cells/µL)
- •WHO performance status: grade 0,1 or 2 at the time of enrollment (For definition of performance status, see: http://www.ecog.org/general/perf_stat.html)
- •Absence of any psychological, familial, sociological, geographical or physical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before study entry
排除标准
- •Participation in any other interventional clinical trial during the study period
- •History or concomitant presence of any other malignancy, except for: A) Non-melanoma skin cancer B) Carcinoma in situ of the cervix C) Any other effectively treated malignancy that has been in remission for >5 years or that is highly likely to be cured at the time of enrollment
- •Known concomitant presence of any immunosuppressive disease (e.g. HIV) or any active autoimmune condition, except for vitiligo
- •Concomitant use of systemic corticosteroids in immunosuppressive doses (>1 mg/kg/day of prednisone, or equivalent dose for other corticosteroid preparations) or any other immunosuppressive agent. A minimum of 4 weeks must have elapsed between the last dose of immunosuppressive therapy and the first vaccination. Topical corticosteroids are permitted, except if applied at the sites of DC injection
- •Pregnant or breast-feeding
结局指标
主要结局
Primary end point: Overall survival
Primary end point: Overall survival
次要结局
- Secondary end point 3: Both for the control group and the intervention group, tumor marker levels will be monitored in peripheral blood. This will be done by measuring WT1 mRNA levels using specific primers and quantitative real-time RT-PCR. Molecular response is defined as the normalization of WT1 transcript levels in peripheral blood below background
- Secondary end point 1 and 2: Clinical response analysis will be performed on all efficacy-evaluable patients according to the ‘Revised Recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia’. Secondary endpoints that will be analyzed are relapse-free survival and relapse rate at two years
- Secondary end point 4: Both for the control group and the intervention group, activation of the immune system will be monitored. Peripheral blood samples will be examined by using flow cytometry for functional WT1-specific T cell responses (e.g. WT1-reactive IFN-γ+ T cells), WT1-specific CD8+ T cells (by tetramer analysis in HLA-A*0201+ patients) and changes in lymphocyte subset distribution and activation state
- Secondary end point 5: Patient-reported outcomes, to evaluate changes in general and disease-specific quality of life using EQ-5D-5L and QLQ-C30 questionnaires at regular time points
研究者
Center for Cell Therapy and Regenerative Medicine
Scientific
Antwerp University Hospital
研究点 (6)
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