2024-511050-44-00招募中2 期
HOVON 146 ALL: Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults. A phase II trial.
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting14 个研究点 分布在 2 个国家目标入组 71 人开始时间: 2024年11月12日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 71
- 试验地点
- 14
- 主要终点
- Proportion of MRD negative response by PCR/FCM after the first blinatumomab consolidation course. MRD negative response is defined as MRD <10^-4 by PCR or FCM
研究概览
简要总结
To assess the proportion of patients that achieve MRD negative response after the first consolidation phase including blinatumomab
研究设计
- 研究类型
- Interventional
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
- •Primary CD19 positive precursor B-ALL (excluding mature B-cell ALL and B-lymphoblastic lymphoma, but including Philadelphia positive/BCR-ABL positive ALL) and CD19 positive mixed phenotype acute lymphoblastic leukemia (MPAL)
- •Patients aged 18 to 70 years inclusive
- •WHO performance status 0-2
- •Negative pregnancy test at inclusion, if applicable
- •Written informed consent
- •Patient is capable of giving informed consent
排除标准
- •Mature B-cell leukemia/lymphoma, B-lymphoblastic lymphoma, isolated extramedullary disease
- •Patients with a currently active second malignancy. Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at < 30% risk of relapse within one year. However, patients with the following history/concurrent conditions are allowed: - Basal or squamous cell carcinoma of the skin, - Carcinoma in situ of the cervix, - Carcinoma in situ of the breast, - Incidental histologic finding of prostate carcinoma
- •Patient known to be HIV-positive
- •Pregnant or breast-feeding female patients
- •Unwilling or not capable to use effective means of birth control (all men, all premenopausal women under the age of 50 need contraception for two years after the last period, and women older than 50 years for at least one year)
- •Current participation in another clinical trial
- •Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Clinically overt central nervous system disease
- •CML in blast crisis
- •Acute undifferentiated leukemia
- •Previous treatment with chemotherapy for precursor B-ALL (maximum 5 days of steroid treatment is allowed)
- •Persistent liver enzyme disorders (ASAT/ALAT) >5xULN despite steroid pre-treatment
- •Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
- •Severe pulmonary dysfunction (CTCAE grade III-IV)
- •Severe neurological or psychiatric disease
- •Active, uncontrolled infection
结局指标
主要结局
Proportion of MRD negative response by PCR/FCM after the first blinatumomab consolidation course. MRD negative response is defined as MRD <10^-4 by PCR or FCM
Proportion of MRD negative response by PCR/FCM after the first blinatumomab consolidation course. MRD negative response is defined as MRD <10^-4 by PCR or FCM
次要结局
- MRD level following induction chemotherapy
- MRD level after second blinatumomab consolidation
- Hematological response after induction, blinatumomab consolidation I and blinatumomab consolidation II
- Event-free survival, i.e. time from registration until no CR on protocol, relapse or death from any cause, whichever comes first. EFS for patients without a CR on protocol will be set at 1 day; this also includes patients with a first CR only after start intensification 1. Patients still in first CR and alive are censored at the last day they were last known to be alive.
- Relapse-free survival (hematologically; i.e. time from CR on protocol until relapse or death from any cause, whichever comes first). Patients still in first CR and alive are censored at the last day they were last known to be alive.
- Overall survival, measured from the time of registration until death from any cause. Patients still alive or lost to follow up are censored at the date they were last known to be alive.
- Adverse events
- RFS and OS from start allogeneic transplantation and from start maintenance RFS, whichever is applicable
- T-cell and B-cell kinetics and assessment of predictive value
- Comparison of the results of molecular and flowcytometric MRD measurements at the same timepoints (sidestudy)
研究者
A.W. Rijneveld
Scientific
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
研究点 (14)
Loading locations...
相似试验
招募中
2 期
Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults. A phase II trial.acute lymphoblastic leukemiaprecursor B-acute lymphoblastic leukemia10024324NL-OMON50553HOVO65
进行中（未招募）
1 期
Blinatumomab added to prephase and consolidation therapy in precursor B-acute lymphoblastic leukemia in adults.A phase II trial.Precursor B-acute lymphoblastic leukemiaMedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864EUCTR2017-000766-30-NLHOVON Foundation71
进行中（未招募）
2 期
Blinatumomab Added to Prephase and Consolidation Therapy in Precursor B-acute Lymphoblastic Leukemia in Adults.ALL, AdultNCT03541083Stichting Hemato-Oncologie voor Volwassenen Nederland71
尚未招募
不适用
Blinatumomab for minimal residual disease before hematopoietic stem cell transplantation in pediatric B-cell precursorKCT0006135Seoul National University Hospital20
进行中（未招募）
2 期
ALL09 - SUbstitute BLinatumomab to Improve Minimal Residual Disease Eradication in Adolescents and Young Adults with Acute Lymphoblastic Leukaemia – The SUBLIME StudyACTRN12618001734257Australasian Leukaemia and Lymphoma Group55