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

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.

Conditions

• Mature B-Cell Leukemia Burkitt Type
• Burkitt Lymphoma (BL)
• Unclassifiable Lymphoma Between DCBL and BL

Interventions

DRUG

Rituximab

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.

DRUG

Methotrexate

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\*

DRUG

Dexamethasone

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\*.

DRUG

Iphosphamid

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\*.

DRUG

Vincristine

Vincristine 2 mg IV bolus. Day 2. Cycles: A1, B1, A2, B2 Vincristine 1 mg IV bolus. Day 2. Cycles: B1\*, B2\*, B3\*

DRUG

Etoposide

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\*.

DRUG

Cytarabine

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\*

DRUG

Cyclophosphamide

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\*

DRUG

Doxorubicin

Doxorubicin 25 mg/m² IV in 15 min. Days 5 and 6. Cycles: B1/B1\*, B2, B2\*, B3\*

DRUG

Vindesine

Vindesine 3 mg/m2 (max 5 mg) IV bolus. Day 2. Cycles: C1, C2

DRUG

Cytarabine

Cytarabine 30 mg IT. Days 2 and 6. Cycles A1, B1, A2, B2

DRUG

Methotrexate

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\*

DRUG

Hydrocortisone

Hydrocortisone 20 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2

DRUG

Prednisone

Prednisone 60 mg/m2 PO or IV bolus. Days 1 to 5. Pre-phase.

Sponsors & Collaborators

• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

  collaborator OTHER

• PETHEMA Foundation

  lead OTHER

Principal Investigators

• JOSEP MARIA RIBERA SANTASUSANA, M.D.; Ph.D. · ICO-Hospital Germans Trias i Pujol

• JUAN MANUEL SANCHO CIA, M.D.; Ph.D. · ICO-Hospital Germans Trias i Pujol

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2024-01-31

Completion

2024-01-31

Countries

• Spain

Study Locations