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NOT YET RECRUITING
NCT07522801
PHASE2

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

Sponsor: Philippe ROUSSELOT

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

15 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

93

Start Date

2026-09-01

Completion Date

2030-03-01

Last Updated

2026-04-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

Venetoclax + Tofacitinib

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

DRUG

Venetoclax+ Everoliumus +Enrylaze

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)

DRUG

Venetoclax + 5 Azacitidine

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

Locations (69)

University Hospital Brno

Brno, Czechia

Czech medical chamber

Prague, Czechia

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

CHU Amiens Picardie

Amiens, France

Chu Angers

Angers, France

CH Victor Dupouy

Argenteuil, France

Centre Hospitalier d'Avignon

Avignon, France

CH cote basque

Bayonne, France

CHU Besancon

Besançon, France

Hopital Avicenne

Bobigny, France

Hopital Haut Leveque

Bordeaux, France

CHU de Brest

Brest, France

CHU Caen

Caen, France

Clinique du Parc

Castelnau-le-Lez, France

HIA Percy

Clamart, France

CHU Clermont Ferrand

Clermont-Ferrand, France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

CHU Henri Mondor

Créteil, France

CHU Dijon Bourgogne

Dijon, France

Centre Hospitalier de Dunkerque

Dunkirk, France

Hopital Annecy Genevois

Épagny, France

CHU de Grenoble

Grenoble, France

Centre Hospitalier de Versailles

Le Chesnay, France

CHU Lille

Lille, France

CHU de Limoges

Limoges, France

Hopital Lyon Sud

Lyon, France

APHM Conception

Marseille, France

Institut Paoli-Calmettes

Marseille, France

Centre Hospitalier Regional Metz Thionville

Metz, France

Hopital Saint Eloi CHU Montpellier

Montpellier, France

GHRMSA - Hopital E Muller

Mulhouse, France

CHU Nantes

Nantes, France

CHU Nice

Nice, France

CHU de Nîmes

Nîmes, France

Chu Orléans

Orléans, France

Hopital Armand Trousseau

Paris, France

Hopital Cochin

Paris, France

Hopital Necker Enfants Malades

Paris, France

Hopital Pitié Salpêtrière

Paris, France

Hopital Robert Debré

Paris, France

Hopital Saint Antoine

Paris, France

Hopital Saint Louis

Paris, France

Hopital Saint Louis

Paris, France

Centre Hospitalier de Perpignan

Perpignan, France

CHU de Poitiers

Poitiers, France

CHU de Reims

Reims, France

Hopital Pontchaillou

Rennes, France

Hopital Victor Provo

Roubaix, France

Centre Henri Becquerel

Rouen, France

CHU Saint Etienne

Saint-Priest-en-Jarez, France

CHU Toulouse

Toulouse, France

CHRU Hopital Bretonneau

Tours, France

CHRU Nancy

Vandœuvre-lès-Nancy, France

CHV

Versailles, France

Institut Gustave Roussy

Villejuif, France

Universtatsklinikum Frankfurt Med. Klinik II

Frankfurt, Germany

Erasmus Medical Center

Rotterdam, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

Wroclaw Medical University

Wroclaw, Poland

Insitut Catala d'Oncologia Badalona

Barcelona, Spain

Vall D'Hebron University Hospital

Barcelona, Spain

Hospital General Universitario Gregorio Marnon

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hopital Gerneral Universitario Morales Meseguar

Murcia, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Hematologist at Hospital Universitario Donostia

San Sebastián, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Universidad de Sevilla Facultad de Medicina

Seville, Spain

Hospital Universitario La Fe

Valencia, Spain