2024-516570-30-00RecruitingPhase 2
A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APPROACH. ALL-TARGET TRIAL
Centre Hospitalier De Versailles67 sites in 3 countries86 target enrollmentStarted: June 1, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 86
- Locations
- 67
- Primary Endpoint
- 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).
Study Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 0 years to 65+ years (0-17 Years, 65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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
Arms & Interventions
Venetoclax, Venetoclax, Venetoclax
Test
Intervention: Venetoclax (Drug)
Azacitidine Mylan 25 mg/mL powder for suspension for injection
Test
Intervention: Azacitidine Mylan 25 mg/mL powder for suspension for injection (Drug)
Afinitor 5 mg tablets
Test
Intervention: Afinitor 5 mg tablets (Drug)
Enrylaze 10 mg/0.5mL, solution for injection/infusion
Test
Intervention: Enrylaze 10 mg/0.5mL, solution for injection/infusion (Drug)
XELJANZ 5 mg film-coated tablets
Test
Intervention: XELJANZ 5 mg film-coated tablets (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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
Investigators
ROUSSELOT Philippe
Scientific
Centre Hospitalier De Versailles
Study Sites (67)
Loading locations...
Similar Trials
Not yet recruiting
Phase 2
A Precision Medicine Trial for Patients With Relapsed or Refractory T Cell ALLLALNCT07522801Philippe ROUSSELOT93
Not yet recruiting
Phase 2
Real-world Trial of Individualized Precision OncologyMetastatic CancerUnresectable CarcinomaNCT07346209University of California, San Diego280
Recruiting
Phase 2
Precision therapy versus standard therapy in Acute Myeloid Leukaemia and Myelodysplastic syndrome in elderly (PALM) – a phase II randomized clinical trialChronic myelomonocyte leukemiaMyelodysplastic syndromeAcute myeloid leukemia2023-509092-16-00Akershus University Hospital33
Not yet recruiting
Phase 2/3
Effectiveness of Rasona Haritaki Vati in lipid disorder {Medoroga}Other disorders of lipoprotein metabolism. Ayurveda Condition: MEDOROGAH,CTRI/2026/01/102295BANARAS HINDU UNIVERSITY80
Not yet recruiting
Not Applicable
To study the effect of Navaka Guggulu and Vatari Guggulu in the management of Amavata(one type of joint disorder).Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH,CTRI/2025/08/093912Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital60