Study: NCT05049473

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Rituximab 375 mg/m² IV. Day 1. Cycles: A1/A1\*, B1/B1\*, C1/A2\*, A2/B2\*, B2/A3\*, C2/B3\*. Two additional doses after 6 cycles in case of localized stage patients without CR after four cycles or advanced stage patients.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Methotrexate 1500 mg/m² IV 24h-infusion. Day 2. Cycles: A1, B1, C1 (1000 mg/m² if patient in CR) , A2 (1000 mg/m² if patient in CR), B2 (1000 mg/m² if patient in CR) , C2 (1000 mg/m² if patient in CR) Methotrexate 500 mg/m² IV 24h-infusion. Day 2. Cycles: A1\*, B1\*, A2\*, B2\*, A3\*, B3\*

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Dexamethasone 10 mg/m² PO or IV bolus. Days: 2 to 6. Cycles: A1/A1\*, B1/B1\*, C1/A2\*, A2/B2\*, B2/A3\*, C2/B3\*.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Iphosphamid
Description: Iphosphamid 800 mg/m² IV in 1 hour. Days: 2 to 6. Cycles: A1, A2 (500 mg/m² if patient in CR).~Iphosphamid 400 mg/m² IV in 1 hour. Days: 2 to 6. Cycles: A1\*.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: Vincristine 2 mg IV bolus. Day 2. Cycles: A1, B1, A2, B2 Vincristine 1 mg IV bolus. Day 2. Cycles: B1\*, B2\*, B3\*

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Etoposide (VP16) 100 mg/m² IV in 1 hour. Days: 5, 6. Cycle: A1, A2. Etoposide (VP16) 250 mg/m² IV in 1 hour. Days: 5, 6. Cycle: C1, C2. Etoposide (VP16) 60 mg/m² IV in 1 hour. Days: 5, 6. Cycle: A1\*, A2\*, A3\*.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Cytarabine 150 mg/m² IV in 1 hour every 12 hours. Days: 5, 6. Cycles: A1, A2 Cytarabine 2 g/m² IV in 3 hours every 12 hours. Day: 6. Cycle: C1 (1.5 g/m² if patient in CR), C2 (1.5 g/m² if patient in CR) Cytarabine 60 mg/m² IV in 1 hour every 12 hours. Days: 5, 6. Cycles: A1\*, A2\*, A3\*

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Cyclophosphamide 200 mg/m² IV in 1 hour. Days 1 to 5. Pre-phase. Cyclophosphamide 200 mg/m² IV in 1 hour. Days 2 to 6. Cycles: B1, B2, B1\*, B2\*, B3\*

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: Doxorubicin 25 mg/m² IV in 15 min. Days 5 and 6. Cycles: B1/B1\*, B2, B2\*, B3\*

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vindesine
Description: Vindesine 3 mg/m2 (max 5 mg) IV bolus. Day 2. Cycles: C1, C2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Cytarabine 30 mg IT. Days 2 and 6. Cycles A1, B1, A2, B2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Methotrexate 12 mg IT. Day 1. Pre-phase Methotrexate 12 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2 Methotrexate 15 mg IT. Day 2. Cycles: A1\*, B1\*, A2\*, B2\*, A3\*, B3\*

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydrocortisone
Description: Hydrocortisone 20 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Prednisone 60 mg/m2 PO or IV bolus. Days 1 to 5. Pre-phase.