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Report for Clinical Trial NCT02611492
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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)
9 Interventions
Name: Nilotinib
Description: 400 mg/12h per os D1 to D28 cycles 1-4 300 mg/12h per os D1-D14 interphase
Type: Drug
Group Labels: 2 Intensive Arm (A) Light Arm (B)
Name: Methotrexate
Description: 1 g/m2 continuous Intravenous Infusion (CIV) D1 cycles 2 and 4 25 mg/m2 per os D1, D8 interphase
Type: Drug
Group Labels: 2 Intensive Arm (A) Light Arm (B)
Name: Aracytine (Ara C)
Description: 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
Type: Drug
Group Labels: 1 Intensive Arm (A)
Name: Granulocyte Colony-Stimulating Factor (G-CSF)
Description: 5µg/kg/d (SC) D6 until neutrophils > 1 G/L D15 cycles 1 and 3; D6 cycles 2 and 4
Type: Drug
Group Labels: 2 Intensive Arm (A) Light Arm (B)
Name: Depomedrol
Description: 40 mg + methotrexate 15 mg + Aracytine (AraC) 40mg IT cycle 1: D1, D8, D15 IT cycles 2 and 4: D9 IT cycle 3: D1
Type: Drug
Group Labels: 2 Intensive Arm (A) Light Arm (B)
Name: Dexamethasone
Description: 40 mg per os, D1-D2, D8-D9, D15-D16, D22-D23, cycles 1 and 3
Type: Drug
Group Labels: 2 Intensive Arm (A) Light Arm (B)
Name: Vincristine
Description: 2 mg total dose IV, D1 D8 D15 D22 cycles 1 and 3
Type: Drug
Group Labels: 2 Intensive Arm (A) Light Arm (B)
Name: Imatinib
Description: 300 mg/12h per os in post-SCT maintenance therapy for during at least 2 years
Type: Drug
Group Labels: 2 Intensive Arm (A) Light Arm (B)
Name: 6 Mercaptopurine (6MP)
Description: 60 mg/m2 per os, D1 to D14, interphase
Type: Drug
Group Labels: 2 Intensive Arm (A) Light Arm (B)
Primary Outcomes
Description: defined as a breakpoint cluster region (BCR)-Abelson (ABL) ratio < 0.1% in the bone marrow sample of MRD4
Measure: Major Molecular Response (MMolR)
Time: 4 cycles (4 months)
Secondary Outcomes
Measure: Complete remission after cycle 1
Time: day 28
Measure: Cumulative incidence of treatment- and transplantation-related mortality
Time: 2 years
Measure: Cumulative incidence of relapse
Time: 10 years
Measure: Relapse free survival
Time: 10 years
Measure: Event-free survival
Time: 10 years
Measure: overall survival
Time: 10 years
Description: mutations will be assessed by Reverse transcription Quantitative Polymerase Chain Reaction (RQ-PCR) sequencing in case of progression or relapse
Measure: T315I mutation
Time: 10 years
Measure: Toxicity
Time: 12 months
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 T315I
T315I mutation. --- T315I ---