Rituximab combined with a specific intensive chemotherapy is considered the standard treatment for newly diagnosed patients with mature B leukemia/lymphoma. However, the toxicity of this therapy is high. The purpose of this trial is to reduce the dose intensity of the chemotherapy blocks once the patient has achieved complete response. With this approach the investigators expect to maintain the efficacy and to reduce the toxicity of the chemotherapy, specially the rate of deaths in complete response.
Patients younger than 55 years in complete response after two blocks of rituximab and specific intensive chemotherapy will receive four additional blocks of rituximab and attenuated chemotherapy (reduction by 33% of the dose of cyclophosphamide, methotrexate and cytarabine) followed by additional rituximab doses as consolidation. Patients older than 55 years will receive the six blocks with attenuated chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
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\*
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\*.
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\*.
Vincristine 2 mg IV bolus. Day 2. Cycles: A1, B1, A2, B2 Vincristine 1 mg IV bolus. Day 2. Cycles: B1\*, B2\*, B3\*
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\*.
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\*
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\*
Doxorubicin 25 mg/m² IV in 15 min. Days 5 and 6. Cycles: B1/B1\*, B2, B2\*, B3\*
Vindesine 3 mg/m2 (max 5 mg) IV bolus. Day 2. Cycles: C1, C2
Cytarabine 30 mg IT. Days 2 and 6. Cycles A1, B1, A2, B2
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\*
Hydrocortisone 20 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2
Prednisone 60 mg/m2 PO or IV bolus. Days 1 to 5. Pre-phase.
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
RECRUITINGHospital Nuestra Señora de Sonsoles
Ávila, Spain
RECRUITINGHospital de Sant Pau
Barcelona, Spain
RECRUITINGHospital del Mar
Barcelona, Spain
RECRUITINGHospital Universitari Vall d'Hebron
Barcelona, Spain
RECRUITINGICO-Hospital Duran i Reynals
Bellvitge, Spain
RECRUITINGHospital Universitario de Basurto
Bilbao, Spain
RECRUITINGHospital San Pedro de Alcántara
Cáceres, Spain
RECRUITINGHospital Reina Sofía
Córdoba, Spain
RECRUITINGHospital Universitario de Donostia
Donostia / San Sebastian, Spain
RECRUITING...and 19 more locations
Overall Survival (OS)
Defined as the time from diagnosis to death by any cause or last follow-up.
Time frame: Throughout the study period. Approximately 3 years
Progression Free Survival (PFS)
Defined as the time from diagnosis to progression disease, relapse or death by any cause or last follow-up.
Time frame: Throughout the study period. Approximately 3 years
Number of patients with toxicity during the treatment period.
Number of patients experiencing different toxicities during the treatment period, classified according to severity and graded according to NCTCAE V4.0
Time frame: Throughout the study period. Approximately 3 years
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