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Report for Clinical Trial NCT02611492

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase III Study, Randomized, to Evaluate the Reduction of Chemotherapy Intensity in Association With Nilotinib (Tasigna®) in Philadelphia Chromosome-positive (Ph+) ALL of Young Adults (18-59 Years Old) (GRAAPH-2014)

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)

NCT02611492 Philadelphia Chromosome Positive Adult Acute Lymphoblastic Leukemia
MeSH:Precursor Cell Lymphoblastic Leukemia-Lymphoma Philadelphia Chromosome

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 ---



HPO Nodes