The Primary objective is to assess the non-inferiority of the experimental arm (arm B) compared to the control arm (arm A) in terms of Major Molecular Response (MMolR) after the 4th cycle (MRD4) in patients aged 18-59 years old with de novo Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
265
400 mg/12h per os D1 to D28 cycles 1-4 300 mg/12h per os D1-D14 interphase
1 g/m2 continuous Intravenous Infusion (CIV) D1 cycles 2 and 4 25 mg/m2 per os D1, D8 interphase
Age\<45 years: 3 mg/m2/12h D2, D3 cycles 2 and 4 Age\>=45 years: 1.5 mg/m2/12h D2, D3 cycles 2 and 4
Hopital Saint Louis
Paris, France
RECRUITINGMajor Molecular Response (MMolR)
defined as a breakpoint cluster region (BCR)-Abelson (ABL) ratio \< 0.1% in the bone marrow sample of MRD4
Time frame: 4 cycles (4 months)
Complete remission after cycle 1
Time frame: day 28
Cumulative incidence of treatment- and transplantation-related mortality
Time frame: 2 years
Cumulative incidence of relapse
Time frame: 10 years
Relapse free survival
Time frame: 10 years
Event-free survival
Time frame: 10 years
overall survival
Time frame: 10 years
T315I mutation
mutations will be assessed by Reverse transcription Quantitative Polymerase Chain Reaction (RQ-PCR) sequencing in case of progression or relapse
Time frame: 10 years
Toxicity
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
5µg/kg/d (SC) D6 until neutrophils \> 1 G/L D15 cycles 1 and 3; D6 cycles 2 and 4
40 mg + methotrexate 15 mg + Aracytine (AraC) 40mg IT cycle 1: D1, D8, D15 IT cycles 2 and 4: D9 IT cycle 3: D1
40 mg per os, D1-D2, D8-D9, D15-D16, D22-D23, cycles 1 and 3
2 mg total dose IV, D1 D8 D15 D22 cycles 1 and 3
300 mg/12h per os in post-SCT maintenance therapy for during at least 2 years
60 mg/m2 per os, D1 to D14, interphase