EUCTR2012-001494-91-BE进行中（未招募）1 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 - WIDEA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
- •Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO).
- •o all French-American-British (FAB) subtypes, except:
- •- M3 (acute promyelocytic leukemia)
- •o all cases of de novo AML or secondary AML with = 20 % blasts in peripheral blood and/or bone marrow, except:
- •- AML secondary to myeloproliferative neoplasms (MPN)
- •- AML secondary to exposure of leukemogenic agents (t-AML), unless treated with CPX-351 chemotherapy or hypomethylating agents combined with venetoclax .
- •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) (hereafter referred as HMA+/- VEN) OR
- •(4) at least two cycles to maximum six cycles of low-dose cytarabine (LDAC) combined with venetoclax (hereafter referred as LDAC+VEN);
- •resulting in:
- •o morphological complete remission (CR), i.e. bone marrow blast count <5% with neutrophil count >1000 cells/µL and platelet count >100,000 cells/µL.
- •o 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.
- •Adult (= 18 years) at very high risk of relapse according to:
- •oAge = 60 years, and/or
- •oAdverse biological features (e.g. adverse cytogenetics, adverse morphological features, adverse molecular features, hyperleukocytosis (> 100000 cells/µL)), and
- •oIneligible for or unwilling to receive hematopoietic stem cell transplantation.
- •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.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
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:
- •o non-melanoma skin cancer
- •o carcinoma in situ of the cervix
- •o 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.
- •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.
- •pregnancy or breast-feeding
研究者
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