NCT07522801尚未招募2 期
A Precision Medicine Randomized Trial for Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemian Based on a Functional Approach
Philippe ROUSSELOT68 个研究点 分布在 2 个国家目标入组 93 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 93
- 试验地点
- 68
- 主要终点
- Remission rate
研究概览
简要总结
To evaluate the benefit of a precision medicine based strategy (targeted therapeutic options (TTOs)) for patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) (in terms of composite remission).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 15y or more (under 18y only for France)
- •Signed informed consent for patients aged ≥ 18 years and signed informed consent from both parents for patients aged between ≥ 15 years and < 18 years (only for France).
- •Patients with T-cell acute lymphoblastic leukemia in first or second relapse or in the refractory phase.
- •Patients with first relapses are eligible if relapse occurred within 24 months post complete remission achievement and if nelarabine is not considered as appropriate salvage therapy.
- •Patients with second and all subsequent relapses are eligible.
- •Refractory patients are defined as patients not responding after at least 2 lines of chemotherapy (induction + salvage).
- •Patients with relapses post-transplant and post CART-cells treatments are eligible.
- •Blast cells in blood and/or bone marrow to allow the shipment to one of the 3 reference laboratories in France, Spain and The Netherlands or An informative biological assessment already performed within 10 days prior to inclusion in one of the three reference laboratories in France, Spain or The Netherlands with at least one targeted therapeutic option validated (TTO1, venetoclax + tofacitinib; TTO2, venetoclax+ everolimus + enrylaze; TTO3, venetoclax + 5-azacytidine) by one of the three National Validation Committees.
- •Adequate ECOG score (0-3).
- •Patients must be affiliated to a National Health systems (see country-based specificity).
- •Patients must not have a contra-indication for venetoclax, tofacitinib, everolimus, glutaminolytic agents (enrylaze) or 5-azacytidine.
- •Willingness of women of child-bearing potential (WOCBP) or of male patients whose sexual partners are WOCBP to use an effective form of contraception during the study and at least 6 months thereafter.
排除标准
- •Patients in palliative care.
- •Patients with late relapses after the first complete remission (> 24 months post complete remission).
- •Patients with extramedullary only relapses or with clinically symptomatic central nervous system (CNS) involvement.
- •Pregnant or lactating women.
- •Participation in another clinical trial with an investigative drug at the time of study enrolment.
- •Individuals with another active uncontrolled malignancy.
- •Known active HBV-, HCV and HIV related diseases.
- •Patient under curatorship or deprived of liberty (except for minors).
- •Patients with contra-indication to chemotherapy except if considered related to the ALL:
- •ASAT (SGOT) and/or ALAT (SGPT) > 5 x ULN
- •Total bilirubin ≥ 2.5 x ULN
- •Estimated glomerular filtration rate (GFR) < 50 mL/mn using the MDRD equation
研究组 & 干预措施
SOC Regular chemotherapy
Active Comparator
干预措施: Venetoclax + Tofacitinib (Drug)
SOC Regular chemotherapy
Active Comparator
干预措施: Venetoclax + 5 Azacitidine (Drug)
SOC Regular chemotherapy
Active Comparator
干预措施: Venetoclax+ Everoliumus +Enrylaze (Drug)
TTO1 Venetoclax + Tofacitinib
Experimental
干预措施: Venetoclax + Tofacitinib (Drug)
TTO2 Venetoclax + Everolimus + Enrylaze
Experimental
干预措施: Venetoclax+ Everoliumus +Enrylaze (Drug)
TTO3 Venetoclax + 5 Azacitidine
Experimental
干预措施: Venetoclax + 5 Azacitidine (Drug)
结局指标
主要结局
Remission rate
时间窗: 3 months
Composite Complete Remission (CRc) rate defined as complete remission (CR) and remission without complete hematological recovery (CRi) by 3 months post-randomization.
次要结局
未报告次要终点
研究者
Philippe ROUSSELOT
Investigator coordonator
Versailles Hospital
研究点 (68)
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