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A Precision Medicine Trial for Patients With Relapsed or Refractory T Cell ALL
Sponsor: Philippe ROUSSELOT
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
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
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)
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