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

Sponsor
Philippe ROUSSELOT
Study ID
NCT07522801
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • LAL

Eligibility Criteria

Sex
ALL
Age
15 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax + Tofacitinib — DRUG
    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 — DRUG
    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 — DRUG
    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 Details

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).

Key Dates

Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Dec 1, 2029
Completion
Mar 1, 2030

Study Design

Enrollment
93 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TTO1 Venetoclax + Tofacitinib
  • Experimental: TTO2 Venetoclax + Everolimus + Enrylaze
  • Experimental: TTO3 Venetoclax + 5 Azacitidine
  • Active Comparator: SOC Regular chemotherapy

Primary Outcome Measure

Remission rate [ Time Frame: 3 months ]

Central Contacts