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UnknownNCT05049473

Treatment of Mature B-ALL and Burkitt Lymphoma (BL) in Adult Patients. BURKIMAB-14.

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
PETHEMA Foundation · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGRituximabRituximab 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.
DRUGMethotrexateMethotrexate 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\*
DRUGDexamethasoneDexamethasone 10 mg/m² PO or IV bolus. Days: 2 to 6. Cycles: A1/A1\*, B1/B1\*, C1/A2\*, A2/B2\*, B2/A3\*, C2/B3\*.
DRUGIphosphamidIphosphamid 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\*.
DRUGVincristineVincristine 2 mg IV bolus. Day 2. Cycles: A1, B1, A2, B2 Vincristine 1 mg IV bolus. Day 2. Cycles: B1\*, B2\*, B3\*
DRUGEtoposideEtoposide (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\*.
DRUGCytarabineCytarabine 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\*
DRUGCyclophosphamideCyclophosphamide 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\*
DRUGDoxorubicinDoxorubicin 25 mg/m² IV in 15 min. Days 5 and 6. Cycles: B1/B1\*, B2, B2\*, B3\*
DRUGVindesineVindesine 3 mg/m2 (max 5 mg) IV bolus. Day 2. Cycles: C1, C2
DRUGCytarabineCytarabine 30 mg IT. Days 2 and 6. Cycles A1, B1, A2, B2
DRUGMethotrexateMethotrexate 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\*
DRUGHydrocortisoneHydrocortisone 20 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2
DRUGPrednisonePrednisone 60 mg/m2 PO or IV bolus. Days 1 to 5. Pre-phase.

Timeline

Start date
2014-01-01
Primary completion
2024-01-01
Completion
2024-01-01
First posted
2021-09-20
Last updated
2021-09-20

Locations

29 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT05049473. Inclusion in this directory is not an endorsement.