A Phase III Randomized Trial of the Reduction of Chemotherapy in Philadelphia Chromosome-positive ALL of Young Adults

PHASE3RecruitingINTERVENTIONAL
Enrollment

265

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2025

Conditions
Philadelphia Chromosome Positive Adult Acute Lymphoblastic Leukemia
Interventions
DRUG

Nilotinib

400 mg/12h per os D1 to D28 cycles 1-4 300 mg/12h per os D1-D14 interphase

DRUG

Methotrexate

1 g/m2 continuous Intravenous Infusion (CIV) D1 cycles 2 and 4 25 mg/m2 per os D1, D8 interphase

DRUG

Aracytine (Ara C)

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

DRUG

Granulocyte Colony-Stimulating Factor (G-CSF)

5µg/kg/d (SC) D6 until neutrophils \> 1 G/L D15 cycles 1 and 3; D6 cycles 2 and 4

DRUG

Depomedrol

40 mg + methotrexate 15 mg + Aracytine (AraC) 40mg IT cycle 1: D1, D8, D15 IT cycles 2 and 4: D9 IT cycle 3: D1

DRUG

Dexamethasone

40 mg per os, D1-D2, D8-D9, D15-D16, D22-D23, cycles 1 and 3

DRUG

Vincristine

2 mg total dose IV, D1 D8 D15 D22 cycles 1 and 3

DRUG

Imatinib

300 mg/12h per os in post-SCT maintenance therapy for during at least 2 years

DRUG

6 Mercaptopurine (6MP)

60 mg/m2 per os, D1 to D14, interphase

Trial Locations (1)

75010

RECRUITING

Hopital Saint Louis, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER