Burkitt Lymphoma (BL), Mature B-Cell Leukemia Burkitt Type, Unclassifiable Lymphoma Between DCBL and BL
Conditions
Keywords
Mature B-ALL, Burkitt lymphoma, Adult
Brief summary
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.
Detailed description
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.
Interventions
DRUGRituximab
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.
DRUGMethotrexate
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\*
DRUGDexamethasone
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\*.
DRUGIphosphamid
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\*.
DRUGVincristine
Vincristine 2 mg IV bolus. Day 2. Cycles: A1, B1, A2, B2 Vincristine 1 mg IV bolus. Day 2. Cycles: B1\*, B2\*, B3\*
DRUGEtoposide
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\*.
DRUGCytarabine
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\*
DRUGCyclophosphamide
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\*
DRUGDoxorubicin
Doxorubicin 25 mg/m² IV in 15 min. Days 5 and 6. Cycles: B1/B1\*, B2, B2\*, B3\*
DRUGVindesine
Vindesine 3 mg/m2 (max 5 mg) IV bolus. Day 2. Cycles: C1, C2
DRUGHydrocortisone
Hydrocortisone 20 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2
DRUGPrednisone
Prednisone 60 mg/m2 PO or IV bolus. Days 1 to 5. Pre-phase.
Sponsors
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
PETHEMA Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Patients diagnosed with de novo mature B-ALL, Burkitt lymphoma (BL). Under physician's criteria, patients with unclassified B-lymphoma with intermediate characteristics between DLBCL and BL could be included. * Candidate to intensive treatment.
Exclusion criteria
* Other ALL subtype different from mature B-ALL/BL * Severe complications not due to mature B-ALL/BL (eg, sepsis, pneumonia, shock or hemorrhage) at diagnosis. * Renal failure not due to mature B-ALL /BL * Heart or liver failure * Severe lung disease * Secondary mature B-ALL/BL * Hypersensitivity to foreign proteins * Previous treatment with cytotoxic drugs * Pregnancy/breastfeeding * Severe psychiatric disease * Lack of social or familiar support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Throughout the study period. Approximately 3 years | Defined as the time from diagnosis to death by any cause or last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Throughout the study period. Approximately 3 years | Defined as the time from diagnosis to progression disease, relapse or death by any cause or last follow-up. |
| Number of patients with toxicity during the treatment period. | Throughout the study period. Approximately 3 years | Number of patients experiencing different toxicities during the treatment period, classified according to severity and graded according to NCTCAE V4.0 |
Countries
Spain
Contacts
Primary ContactCarmen López-Carrero
Backup ContactOlga García Calduch
Outcome results
None listed