肿瘤细胞治疗研究
英文原题：Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission
Efficacy Study of Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia in Remission
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
⚠ 该试验的登记信息已有 31 个月未更新， 页面上显示的「进行中（不再招募）」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 II 期注册临床试验，评估细胞治疗用于急性髓系白血病的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 130 例。试验地点：欧洲 · 安特卫普、布鲁塞尔、根特、列日（共 8 个中心）。登记号：NCT01686334。
不限性别 · ≥ 18 Years
纳入标准 • 根据世界卫生组织（WHO）2008年标准确诊急性髓系白血病（AML）。 • 法美英（FAB）分型包括除M3（急性早幼粒细胞白血病）以外的所有亚型。 • 新发AML或继发性AML患者外周血和／或骨髓原始细胞比例≥20%；但不包括： • 继发于骨髓增殖性肿瘤（MPN）的AML； • 继发于白血病致癌物暴露的治疗相关AML（t-AML），除非接受CPX-351化疗，或接受去甲基化药物联合维奈克拉治疗。 • 完成以下任一治疗方案： • I）强化化疗： • （1）至少1个诱导化疗周期和1个巩固化疗周期（允许以低剂量阿糖胞苷作为巩固治疗）；或 • （2）接受1～2个CPX-351诱导治疗周期，及最多2个CPX-351巩固治疗周期；或 • II）低强度化疗： • （3）接受至少2个、最多6个去甲基化药物治疗周期，可联合或不联合维奈克拉；或 • （4）接受至少2个、最多6个低剂量阿糖胞苷联合维奈克拉治疗周期； • 且达到以下缓解状态之一： • 形态学完全缓解（CR）：骨髓原始细胞<5%，中性粒细胞>1,000个/μL且血小板>100,000个/μL；或 • 形态学完全缓解伴血细胞恢复不全（CRi）：骨髓原始细胞<5%，但中性粒细胞<1,000个/μL或血小板<100,000个/μL。 本研究方案要求血小板计数>50,000个/μL。 • 成年患者（≥18岁），且复发风险极高，符合以下条件： • 年龄≥60岁，和／或 • 具有不良生物学特征（例如不良细胞遗传学、不良形态学特征、不良分子特征或高白细胞增多〔>100,000个/μL〕）；并且 • 不适合或不愿接受造血干细胞移植。 • 入组时WHO体能状态为0、1或2级。体能状态定义见：http://www.ecog.org/general/perf_stat.html。 • 无任何可能妨碍遵循研究方案和随访安排的心理、家庭、社会、地理或身体状况；入组前应与患者讨论这些情况。 排除标准 • 研究期间参加其他干预性临床试验。 • 既往或当前患有其他恶性肿瘤，但以下情况除外： • 非黑色素瘤皮肤癌； • 宫颈原位癌； • 其他已接受根治性有效治疗且缓解>5年，或入组时高度可能已治愈的恶性肿瘤。 • 合并免疫抑制性疾病（如HIV）或活动性自身免疫性疾病；白癜风除外。 • 同时使用免疫抑制剂量的全身糖皮质激素（泼尼松>1 mg/kg/日，或其他糖皮质激素的等效剂量）或任何其他免疫抑制剂。首次接种前，末次免疫抑制治疗至少须间隔4周。允许使用局部糖皮质激素，但不得涂于树突状细胞注射部位。 • 妊娠或哺乳期。
Inclusion Criteria:
* Diagnosis of acute myeloid leukemia (AML) according to the 2008 criteria of the World Health Organization (WHO).
* all French-American-British (FAB) subtypes, except:
\- M3 (acute promyelocytic leukemia)
* 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 whether or not combined with venetoclax OR
* (4) at least two cycles to maximum six cycles of low-dose cytarabine combined with venetoclax;
* resulting in:
* 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
* 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:
* Age ≥ 60 years, and/or
* Adverse biological features (e.g. adverse cytogenetics, adverse morphological features, adverse molecular features, hyperleukocytosis (\> 100000 cells/µL)), and
* Ineligible 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.
Exclusion Criteria:
* Participation in any other interventional clinical trial during the study period.
* History or concomitant presence of any other malignancy, except for:
* non-melanoma skin cancer
* carcinoma in situ of the cervix
* 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.
* Pregnant or breast-feeding以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Overall survival · The primary objective of this randomized phase II clinical study is to determine the effect of WT1-targeted dendritic cell vaccination on overall survival in adult AML patients at very high risk of relapse and in complete remission. · At study completion, an average of 5 year
次要终点：Relapse rate；relapse-free survival；Change in WT1 mRNA levels in peripheral blood；Immune activation；General and disease-specific quality of life
接种自体WT1 mRNA电转树突状细胞疫苗，并接受随访照护。接受低强度化疗的患者可在树突状细胞疫苗接种期间继续该治疗。
接受随访照护。接受低强度化疗的患者可在随访照护期间继续该治疗。
本项创新免疫治疗研究的首要目标是确定：在我们既往Ⅰ／Ⅱ期研究中观察到的抗白血病作用，能否在更大患者队列中得到证实；以及树突状细胞疫苗能否通过清除微小残留病，显著预防复发并延长急性髓系白血病（AML）患者生存。
The primary aim of this innovative immunotherapeutic study is to determine whether the antileukemic effects seen in our previous phase I/II study can be confirmed in a large cohort of patients and whether dendritic cell vaccination can significantly prevent relapse and increase survival of acute myeloid leukemia (AML) patients by eradicating minimal residual disease.
MEMBER ACCOUNT
登录成功会直接打开下一页。