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ClinicalTrials.gov ID

NCT07522801

Lead Sponsor

Philippe ROUSSELOTOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

93Estimated

Last Update Posted

Apr 17, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Dec 1, 2029Estimated

Completion Date

Mar 1, 2030Estimated

Official Title

A Precision Medicine Randomized Trial for Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemian Based on a Functional Approach

Brief Summary

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).

• LAL

• Venetoclax + Tofacitinib
• Venetoclax+ Everoliumus +Enrylaze
• Venetoclax + 5 Azacitidine

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Patients aged 15y or more (under 18y only for France)

2. 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).

3. Patients with T-cell acute lymphoblastic leukemia in first or second relapse or in the refractory phase.

   1. 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.
   2. Patients with second and all subsequent relapses are eligible.
   3. Refractory patients are defined as patients not responding after at least 2 lines of chemotherapy (induction + salvage).
   4. Patients with relapses post-transplant and post CART-cells treatments are eligible.

4. 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.

5. Adequate ECOG score (0-3).

6. Patients must be affiliated to a National Health systems (see country-based specificity).

7. Patients must not have a contra-indication for venetoclax, tofacitinib, everolimus, glutaminolytic agents (enrylaze) or 5-azacytidine.

8. 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.

Exclusion Criteria:

1. Patients in palliative care.

2. Patients with late relapses after the first complete remission (> 24 months post complete remission).

3. Patients with extramedullary only relapses or with clinically symptomatic central nervous system (CNS) involvement.

4. Pregnant or lactating women.

5. Participation in another clinical trial with an investigative drug at the time of study enrolment.

6. Individuals with another active uncontrolled malignancy.

7. Known active HBV-, HCV and HIV related diseases.

8. Patient under curatorship or deprived of liberty (except for minors).

9. 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Philippe ROUSSELOTOTHER

cyril.salek@uhkt.cz+420221977301

achaib@ch-aix.fr+33442339030

joris.magalie@chu-amiens.fr+33322455914

mahunault@chu-angers.fr+33241354472

benjamin.papoular@ch-argentuil.fr+33134233731

chebrek.safia@ch-avignon.fr+33432759398

abanos@ch-cotebasque.fr+33559443832

msimonet@chu-besancon.fr+33381668232

thorsten.braun@aphp.fr+33148957071

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gaelle.guillerm@chu-brest.fr+33298223504

chantepie-s@chu-caen.fr+33231272122

alexandre.payssot.hematoparc@outlook.fr+33467331331

johanna.konopacki@intradef.gouv.fr+33141466301

aravinet@chu-clermontferrand.fr+33473750065

anne-marie.ronchetti@chsf.fr+33161693178

sebastien.maury@aphp.fr+33149812059

julie.guerder@chu-dijon.fr+33380295918

adrien.daniel@ch-dunkerque.fr+33328285633

nmauz@ch-annecygenevois.fr+33450636608

athiebautbertrand@chu-grenoble.fr+33476765755

phrousselot@ght78sud.fr+33139638909

celine.berthon@chu-lille.fr+33320444290

pascal.turlure@chu-limoges.fr+33555058039

marie.balsat@chu-lyon.fr+33478862237

laure.de.lassus@ap-hm.fr

hicheriy@ipc.unicancer.fr+33491223695

houria.debarri@chr-metz-thioville.fr+33387553564

l-gabellier@chu-montpellier.fr+33467338354

mathilde.lamarque@ghrmsa.fr+33389647755

patrice.chevallier@chu-nantes.fr+33240083271

cluzeau.t@chu-nice.fr+33492035893

stefan.wickenhauser@chu-nimes.fr+33466684033

magda.alexis@chu-orleans.fr+33238514210

mathieu.simonin@aphp.fr+33144736604

justine.decroocq@aphp.fr+33158412131

felipe.suarez@aphp.fr+33144495368

madalina.uzunov@aphp.fr+33142162820

marie-emilie.dourthe@aphp.fr+33140034766

eolia.brissot@aphp.fr+33149283441

nicolas.boissel@aphp.fr+33142499643

etienne.lengline@aphp.fr+33142499637

alexandrekarangwa@ch-perpignan.fr+33468618879

maria-pillar.gallego-hernanz@chu-poitiers.mssante.fr+33549444444

chimberlin@chu-reims.fr+33326783644

martin.escoffre-barbe@chu-rennes.fr+33299284291

julia.hieulle@ch-roubaix.fr+33320993270

emilie.lemasle@chb.unicancer.fr+33232082221

emmanuelle.tavernier@chu-st-etienne.fr+33477917060

tavitian.suzanne@iuct-oncopole.fr+33531156305

m.eloit@chu-tours.fr+33247473712

c.bonmati@chru-nancy.fr+33383153282

phrousselot@ght78sud.fr+33139638909

florence.pasquier@gustaveroussy.fr+33142115376

a.rijneveld@ersasmusmc.nl+31107033123

l.e.vanderwagen@umcutrecht.nl+31 88 755 76 55

atorrent@iconcologia.net+34934978387

pbarba@vhio.net+34932746042

mariaalmudena.de@salud.madrid.org+34914269826

alfonsoff@outlook.es+34670634318

+34923291316

paulina_hillebrand@islafe.es+34961244927