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New hope for tough leukemia: precision drug combo trial launches

NCT ID NCT07522801

Disease control Sponsor: Philippe ROUSSELOT Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether personalized drug combinations can help people with relapsed or treatment-resistant T-cell acute lymphoblastic leukemia (T-ALL). Researchers will assign patients to one of several targeted therapies based on lab tests. The main goal is to see if these treatments can achieve complete remission within three months. About 93 participants aged 15 and older will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Venetoclax, Tofacitinib, Everolimus, Enrylaze
What this could lead to
If successful, this could offer a new treatment option for patients with hard-to-treat T-cell leukemia, potentially leading to better remission rates.
What could go wrong
This is an early phase 2 trial with only 93 participants, so results may not apply to everyone. The drug combinations can cause side effects, and the study hasn't started recruiting yet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 93 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lymphangioleiomyomatosis T-cell acute lymphoblastic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

LAL

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    69 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHM Conception

    Marseille, France

  • CH Victor Dupouy

    Argenteuil, France

  • CH cote basque

    Bayonne, France

  • CHRU Hopital Bretonneau

    Tours, France

  • CHRU Nancy

    Vandœuvre-lès-Nancy, France

  • CHU Amiens Picardie

    Amiens, France

  • CHU Besancon

    Besançon, France

  • CHU Caen

    Caen, France

  • CHU Clermont Ferrand

    Clermont-Ferrand, France

  • CHU Dijon Bourgogne

    Dijon, France

  • CHU Henri Mondor

    Créteil, France

  • CHU Lille

    Lille, France

  • CHU Nantes

    Nantes, France

  • CHU Nice

    Nice, France

  • CHU Saint Etienne

    Saint-Priest-en-Jarez, France

  • CHU Toulouse

    Toulouse, France

  • CHU de Brest

    Brest, France

  • CHU de Grenoble

    Grenoble, France

  • CHU de Limoges

    Limoges, France

  • CHU de Nîmes

    Nîmes, France

  • CHU de Poitiers

    Poitiers, France

  • CHU de Reims

    Reims, France

  • CHV

    Versailles, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier Regional Metz Thionville

    Metz, France

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, France

  • Centre Hospitalier d'Avignon

    Avignon, France

  • Centre Hospitalier de Dunkerque

    Dunkirk, France

  • Centre Hospitalier de Perpignan

    Perpignan, France

  • Centre Hospitalier de Versailles

    Le Chesnay, France

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence, France

  • Chu Angers

    Angers, France

  • Chu Orléans

    Orléans, France

  • Clinique du Parc

    Castelnau-le-Lez, France

  • Czech medical chamber

    Prague, Czechia

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • GHRMSA - Hopital E Muller

    Mulhouse, France

  • HIA Percy

    Clamart, France

  • Hematologist at Hospital Universitario Donostia

    San Sebastián, Spain

  • Hopital Annecy Genevois

    Épagny, France

  • Hopital Armand Trousseau

    Paris, France

  • Hopital Avicenne

    Bobigny, France

  • Hopital Cochin

    Paris, France

  • Hopital Gerneral Universitario Morales Meseguar

    Murcia, Spain

  • Hopital Haut Leveque

    Bordeaux, France

  • Hopital Lyon Sud

    Lyon, France

  • Hopital Necker Enfants Malades

    Paris, France

  • Hopital Pitié Salpêtrière

    Paris, France

  • Hopital Pontchaillou

    Rennes, France

  • Hopital Robert Debré

    Paris, France

  • Hopital Saint Antoine

    Paris, France

  • Hopital Saint Eloi CHU Montpellier

    Montpellier, France

  • Hopital Saint Louis

    Paris, France

  • Hopital Saint Louis

    Paris, France

  • Hopital Victor Provo

    Roubaix, France

  • Hospital General Universitario Gregorio Marnon

    Madrid, Spain

  • Hospital Universitario La Fe

    Valencia, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Spain

  • Hospital Universitario de Salamanca

    Salamanca, Spain

  • Insitut Catala d'Oncologia Badalona

    Barcelona, Spain

  • Institut Gustave Roussy

    Villejuif, France

  • Institut Paoli-Calmettes

    Marseille, France

  • Universidad de Sevilla Facultad de Medicina

    Seville, Spain

  • University Hospital Brno

    Brno, Czechia

  • University Medical Center Utrecht

    Utrecht, Netherlands

  • Universtatsklinikum Frankfurt Med. Klinik II

    Frankfurt, Germany

  • Vall D'Hebron University Hospital

    Barcelona, Spain

  • Wroclaw Medical University

    Wroclaw, Poland