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

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Collaborator: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Treatments: Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Etoposide; Hydrocortisone; Methotrexate; Prednisone; Rituximab; Vincristine; Vindesine

Criteria

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