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AzTrials

LALPhase 2ALL-TARGETNCT07522801

A Precision Medicine Trial for Patients With Relapsed or Refractory T Cell ALL

A Phase 2 study testing Venetoclax + Tofacitinib, Venetoclax+ Everoliumus +Enrylaze and Venetoclax + 5 Azacitidine in people with LAL, run by Philippe ROUSSELOT at 69 sites in 6 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 15 to 99 years
Conditions the study is for
LAL
What is being tested?
Venetoclax + Tofacitinib, Venetoclax+ Everoliumus +Enrylaze and Venetoclax + 5 Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
69 sitesin 6 countries
Study dates
1 Sep 2026to 1 Mar 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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

Trial locations and contacts

69 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Melody FORT contact

+33-1-39-23-97-76

mfort@ght78sud.fr

Sandrine ROUX contact

+33-1-39-23-97-77

sroux@ght78sud.fr

69 sites in 6 countries

France53 sites

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence

    Abdelaziz Chaib, +33442339030, achaib@ch-aix.fr

  • CHU Amiens Picardie

    Amiens

    Magalie Joris, +33322455914, joris.magalie@chu-amiens.fr

  • Chu Angers

    Angers

    Mathilde Hunault, +33241354472, mahunault@chu-angers.fr

  • CH Victor Dupouy

    Argenteuil

    Benjamin Papoular, +33134233731, benjamin.papoular@ch-argentuil.fr

  • Centre Hospitalier d'Avignon

    Avignon

    Safia Chebrek, +33432759398, chebrek.safia@ch-avignon.fr

  • CH cote basque

    Bayonne

    Anne Banos, +33559443832, abanos@ch-cotebasque.fr

  • CHU Besancon

    Besançon

    Marion Simonet-Boissard, +33381668232, msimonet@chu-besancon.fr

  • Hopital Avicenne

    Bobigny

    Thorsten Braun, +33148957071, thorsten.braun@aphp.fr

  • Hopital Haut Leveque

    Bordeaux

    Thibaut Leguay, +33557656511, thibaut.leguay@chu-bordeaux.fr

  • CHU de Brest

    Brest

    Gaelle Guillerm, +33298223504, gaelle.guillerm@chu-brest.fr

  • CHU Caen

    Caen

    Sylvain Chantepie, +33231272122, chantepie-s@chu-caen.fr

  • Clinique du Parc

    Castelnau-le-Lez

    Alexandre Payssot, +33467331331, alexandre.payssot.hematoparc@outlook.fr

  • HIA Percy

    Clamart

    Johanna Konopacki, +33141466301, johanna.konopacki@intradef.gouv.fr

  • CHU Clermont Ferrand

    Clermont-Ferrand

    Aurélie Ravinet, +33473750065, aravinet@chu-clermontferrand.fr

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes

    Anne-Marie Ronchetti, +33161693178, anne-marie.ronchetti@chsf.fr

  • CHU Henri Mondor

    Créteil

    Sebastien Maury, +33149812059, sebastien.maury@aphp.fr

  • CHU Dijon Bourgogne

    Dijon

    Julie Guerder-Jolliet, +33380295918, julie.guerder@chu-dijon.fr

  • Centre Hospitalier de Dunkerque

    Dunkirk

    Adrien Daniel, +33328285633, adrien.daniel@ch-dunkerque.fr

  • Hopital Annecy Genevois

    Épagny

    Natacha Mauz, +33450636608, nmauz@ch-annecygenevois.fr

  • CHU de Grenoble

    Grenoble

    Anne Thiebaut, +33476765755, athiebautbertrand@chu-grenoble.fr

  • Centre Hospitalier de Versailles

    Le Chesnay

    Philippe Rousselot, +33139638909, phrousselot@ght78sud.fr

  • CHU Lille

    Lille

    Céline Berthon, +33320444290, celine.berthon@chu-lille.fr

  • CHU de Limoges

    Limoges

    Pascal Turlure, +33555058039, pascal.turlure@chu-limoges.fr

  • Hopital Lyon Sud

    Lyon

    Marie Balsat, +33478862237, marie.balsat@chu-lyon.fr

  • APHM Conception

    Marseille

    Laure De Lassus, laure.de.lassus@ap-hm.fr

  • Institut Paoli-Calmettes

    Marseille

    Yors Hicheri, +33491223695, hicheriy@ipc.unicancer.fr

  • Centre Hospitalier Regional Metz Thionville

    Metz

    Hourria Debarri, +33387553564, houria.debarri@chr-metz-thioville.fr

  • Hopital Saint Eloi CHU Montpellier

    Montpellier

    Ludovic Gabellier, +33467338354, l-gabellier@chu-montpellier.fr

  • GHRMSA - Hopital E Muller

    Mulhouse

    Mathilde Lamarque, +33389647755, mathilde.lamarque@ghrmsa.fr

  • CHU Nantes

    Nantes

    Patrice Chevallier, +33240083271, patrice.chevallier@chu-nantes.fr

  • CHU Nice

    Nice

    Thomas Cluzeau, +33492035893, cluzeau.t@chu-nice.fr

  • CHU de Nîmes

    Nîmes

    Stefan Wickenhauser, +33466684033, stefan.wickenhauser@chu-nimes.fr

  • Chu Orléans

    Orléans

    Magda Alexis, +33238514210, magda.alexis@chu-orleans.fr

  • Hopital Armand Trousseau

    Paris

    Mathieu Simonin, +33144736604, mathieu.simonin@aphp.fr

  • Hopital Cochin

    Paris

    Justine Decroocq, +33158412131, justine.decroocq@aphp.fr

  • Hopital Necker Enfants Malades

    Paris

    Felipe Suarez, +33144495368, felipe.suarez@aphp.fr

  • Hopital Pitié Salpêtrière

    Paris

    Madalina Uzunov, +33142162820, madalina.uzunov@aphp.fr

  • Hopital Robert Debré

    Paris

    Marie-Emilie Dourthe, +33140034766, marie-emilie.dourthe@aphp.fr

  • Hopital Saint Antoine

    Paris

    Elio Brissot, +33149283441, eolia.brissot@aphp.fr

  • Hopital Saint Louis

    Paris

    Nicolas Boissel, +33142499643, nicolas.boissel@aphp.fr

  • Hopital Saint Louis

    Paris

    Etienne Lengline, +33142499637, etienne.lengline@aphp.fr

  • Centre Hospitalier de Perpignan

    Perpignan

    Alexandre Karangwa, +33468618879, alexandrekarangwa@ch-perpignan.fr

  • CHU de Poitiers

    Poitiers

    Maria Pilar Gallego Hernanz, +33549444444, maria-pillar.gallego-hernanz@chu-poitiers.mssante.fr

  • CHU de Reims

    Reims

    Chantal Himberlin, +33326783644, chimberlin@chu-reims.fr

  • Hopital Pontchaillou

    Rennes

    Martine Escoffre-Barre, +33299284291, martin.escoffre-barbe@chu-rennes.fr

  • Hopital Victor Provo

    Roubaix

    Julia Hieulle, +33320993270, julia.hieulle@ch-roubaix.fr

  • Centre Henri Becquerel

    Rouen

    Emilie Lesmasle, +33232082221, emilie.lemasle@chb.unicancer.fr

  • CHU Saint Etienne

    Saint-Priest-en-Jarez

    Emmanuelle Tavernier, +33477917060, emmanuelle.tavernier@chu-st-etienne.fr

  • CHU Toulouse

    Toulouse

    Suzanne Tavitian, +33531156305, tavitian.suzanne@iuct-oncopole.fr

  • CHRU Hopital Bretonneau

    Tours

    Martin Eloit, +33247473712, m.eloit@chu-tours.fr

  • CHRU Nancy

    Vandœuvre-lès-Nancy

    Caroline Bonmati, +33383153282, c.bonmati@chru-nancy.fr

  • CHV

    Versailles

    Philippe Rousselot, +33139638909, phrousselot@ght78sud.fr

  • Institut Gustave Roussy

    Villejuif

    Florence Pasquier, +33142115376, florence.pasquier@gustaveroussy.fr

Other trials in France

Spain10 sites

  • Insitut Catala d'Oncologia Badalona

    Barcelona

    Anna Torrent Catarineu, +34934978387, atorrent@iconcologia.net

  • Vall D'Hebron University Hospital

    Barcelona

    Pere Barba Sunol, +34932746042, pbarba@vhio.net

  • Hospital General Universitario Gregorio Marnon

    Madrid

    Lorenzo Almudena de Laiglesia, +34914269826, mariaalmudena.de@salud.madrid.org

  • Hospital Universitario Virgen de la Victoria

    Málaga

    Alfonso Fernandez Fernandez, +34670634318, alfonsoff@outlook.es

  • Hopital Gerneral Universitario Morales Meseguar

    Murcia

    Maria Luz Amigo Lozano, +34968360969, marial.amigo@carm.es

  • Hospital Universitario de Salamanca

    Salamanca

    Monica Cabrero Calvo, +34923291316

  • Hematologist at Hospital Universitario Donostia

    San Sebastián

  • Hospital Universitario Marques de Valdecilla

    Santander

    Maria Bermudez Rodriguez, 942315321, maria.bermudez@scsalud.es

  • Universidad de Sevilla Facultad de Medicina

    Seville

    José Gonzalez Campos

  • Hospital Universitario La Fe

    Valencia

    Paulina Hillebrand, +34961244927, paulina_hillebrand@islafe.es

Other trials in Spain

Czechia2 sites

  • University Hospital Brno

    Brno

    Michael Doubek, +420532233642, doubek.michael@fnbrno.cz

  • Czech medical chamber

    Prague

    Cyril Salek, +420221977301, cyril.salek@uhkt.cz

Other trials in Czechia

Netherlands2 sites

  • Erasmus Medical Center

    Rotterdam

    +31107033123, a.rijneveld@ersasmusmc.nl

  • University Medical Center Utrecht

    Utrecht

    Lotte Emilia Van der Wagen, +31 88 755 76 55, l.e.vanderwagen@umcutrecht.nl

Other trials in Netherlands

Germany1 site

  • Universtatsklinikum Frankfurt Med. Klinik II

    Frankfurt

    Anjali Cremer, +49 69-6301-4634, a.cremer@med.uni-frankfurt.de

Other trials in Germany

Poland1 site

  • Wroclaw Medical University

    Wroclaw

    Anna Czyz

    +48713436847, aczyz@onet.eu

Other trials in Poland

About this study

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

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).

Conditions
LAL
Being tested
Venetoclax + Tofacitinib, Venetoclax+ Everoliumus +Enrylaze, Venetoclax + 5 Azacitidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Venetoclax + TofacitinibDrug

    Cycle 1:

    Venetoclax, 100 mg/d PO day1; 200 mg/d day2; 300 mg/d day3 and 400 mg/day thereafter (100 mg/day in case of concomitant administration of azoles) Tofacitinib, 10 mg BID PO started from day 5

    Cycle 2 and 3 (4, 5 and 6 if applicable):

    Venetoclax, 400 mg/day PO (100 mg/day in case of concomitant administration of azoles) Tofacitinib, 10 mg BID PO

  • Venetoclax+ Everoliumus +EnrylazeDrug

    Cycle 1:

    Venetoclax, 100 mg/d PO day1; 200 mg/d day2; 300 mg/d day3 and 400 mg/day thereafter (100 mg/day in case of concomitant administration of azoles)

    Everolimus, 5 mg/day orally continuously. Everolimus must be administered at least 6 hours after venetoclax.

    Enrylaze 25 mg/m2 intravenously at day1, 3, 5, 7 (half dose for patients >50 years)

    Cycle 2 and 3 (4, 5 and 6 if applicable):

    Venetoclax, 400 mg/day PO (100 mg/day in case of concomitant administration of azoles)

    Everolimus, 5 mg/day orally continuously (based on tolerance, in the absence of related AE > 1, everolimus daily dose can be increased to 10 mg/d). Everolimus must be administered at least 6 hours after venetoclax.

    Enrylaze 25 mg/m2 intravenously at day1, 3, 5, 7 (half dose for patients >50 years)

  • Venetoclax + 5 AzacitidineDrug

    Cycle 1:

    Venetoclax, 100 mg/day PO day1; 200 mg/d day2; 300 mg/d day3 and 400 mg/day thereafter (100 mg/d in case of concomitant administration of azoles) 5-azacytidine, 75 mg/m² sub cut QD started from day5 to day10

    Cycle 2 and 3 (4, 5 and 6 if applicable):

    Venetoclax, PO 400 mg/day (100 mg/day in case of concomitant administration of azoles) 5-azacytidine, 75 mg/m² sub cut QD started from day1 to day7

Study groups in NCT07522801
Study groupRoleWhat they receive
TTO1 Venetoclax + TofacitinibExperimentalNot described
Receives: Drug: Venetoclax + Tofacitinib
TTO2 Venetoclax + Everolimus + EnrylazeExperimentalNot described
Receives: Drug: Venetoclax+ Everoliumus +Enrylaze
TTO3 Venetoclax + 5 AzacitidineExperimentalNot described
Receives: Drug: Venetoclax + 5 Azacitidine
SOC Regular chemotherapyActive comparatorNot described
Receives: Drug: Venetoclax + Tofacitinib; Drug: Venetoclax+ Everoliumus +Enrylaze; Drug: Venetoclax + 5 Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remission rate

    Composite Complete Remission (CRc) rate defined as complete remission (CR) and remission without complete hematological recovery (CRi) by 3 months post-randomization.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Dec 2029 (estimated)
  4. Study completion1 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07522801
Sponsor's protocol ID
P23/15_All Target
Other IDs
2024-516570-30-00
Acronym
ALL-TARGET
Status last verified
Apr 2026
First submitted
4 Apr 2026
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax + Tofacitinib, Venetoclax+ Everoliumus +Enrylaze and Venetoclax + 5 Azacitidine in people with LAL, run by Philippe ROUSSELOT at 69 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in France, Spain, Czechia, Netherlands, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melody FORT (+33-1-39-23-97-76, mfort@ght78sud.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission rate (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07522801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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