2024-516570-30-00招募中2 期
A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APPROACH. ALL-TARGET TRIAL
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 67
- 主要终点
- Hematological remission rate, which is a composite outcome (CRc), defined as the best response observed within 3 months post randomization, either complete remission (CR) or remission without complete hematological recovery (CRi).
研究概览
简要总结
Evaluer le bénéfice d’une stratégie basée sur la médecine de précision (combinaisons de traitements ciblés (CTC)) sur le taux de réponse hématologique chez des patients atteints de leucémie aiguë lymphoblastique T en rechute ou réfractaire.
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 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. a) 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. b) Patients with second and all subsequent relapses are eligible. c) Refractory patients are defined as patients not responding after at least 2 lines of chemotherapy (induction + salvage). d) 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 3 months thereafter (see Annex 13.9).
排除标准
- •Patients in palliative care.
- •Administration of live or live-attenuated vaccines within 4 weeks prior to the first dose of study treatment (see Annex 13.10)
- •Subject presenting with psychiatric disorders or any other condition that impair their ability to cooperate with study procedures.
- •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
Venetoclax, Venetoclax, Venetoclax
Test
干预措施: Venetoclax (Drug)
Azacitidine Mylan 25 mg/mL powder for suspension for injection
Test
干预措施: Azacitidine Mylan 25 mg/mL powder for suspension for injection (Drug)
Afinitor 5 mg tablets
Test
干预措施: Afinitor 5 mg tablets (Drug)
Enrylaze 10 mg/0.5mL, solution for injection/infusion
Test
干预措施: Enrylaze 10 mg/0.5mL, solution for injection/infusion (Drug)
XELJANZ 5 mg film-coated tablets
Test
干预措施: XELJANZ 5 mg film-coated tablets (Drug)
结局指标
主要结局
Hematological remission rate, which is a composite outcome (CRc), defined as the best response observed within 3 months post randomization, either complete remission (CR) or remission without complete hematological recovery (CRi).
Hematological remission rate, which is a composite outcome (CRc), defined as the best response observed within 3 months post randomization, either complete remission (CR) or remission without complete hematological recovery (CRi).
次要结局
- 12. Mechanisms of resistance to therapies
- 1. Hematological response rate (HR) defined as complete remission (CR), remission without complete hematological recovery (CRi) and partial response (PR) by 3 months post randomization.
- 2. Overall survival, defined as the time from randomization up to death, whatever the cause
- 3. Stable disease by 3 months
- 4. Duration of response
- 5. Event free survival, defined as the time from randomization up to relapse or death, whichever occurred first
- 6. Relapse free survival, defined as the time from response up to relapse or death
- 7. Adverse events and cumulative incidence of adverse events (treatment duration + 1 mois)
- 8. Response per treatment combination by 3 and 6 months
- 9. Bridge to transplant, bridge to CART-cell
- 10. Minimal residual disease at 3 months in responding patients
- 11. Quality of life (HM-PRO & HADS) questionnaires monthly up to 3 months
- 13. Post-hoc analysis of TTO allocation
研究者
ROUSSELOT Philippe
Scientific
Centre Hospitalier De Versailles
研究点 (67)
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