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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
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
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)
Remission rate
Composite Complete Remission (CRc) rate defined as complete remission (CR) and remission without complete hematological recovery (CRi) by 3 months post-randomization.
Time frame: 3 months
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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
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
...and 59 more locations