Rituximab Combined With Chemotherapy in Burkitt's Lymphoma

Study Overview
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Brief Summary
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The purpose of this clinical trial is to prove the efficacy of the following new regimen treatment: Administration of anti-CD20 (Rituximab) combined with chemotherapy. Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C) Prophylactic administration of G-CSF after all chemotherapy cycles local irradiation after 6 cycle if CNS was affected or if there are residual tumour

Detailed Description
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Clinical Trial with a pharmaceutical speciality in new conditions to use.

Official Title
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Burkimab:Study Multicenter of Optimization of the Treatment of LLA-B and the Burkitt's Lymphoma in Adult Patients (From 15 Years Old)

Conditions
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Acute Lymphoblastic Leukemia, Burkitt's Lymphoma

Intervention / Treatment
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* Drug: RITUXIMAB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with mature LLA-B cell (LLA-L3) Patients diagnosed with Burkitt´s and Burkitt´s Like Lymphoma Patients 15 years old or up Written Informed Consent signed Exclusion Criteria: Serious complications related with LAL3/LB or Secondary illness: Serious complications, uncontrollable, for example, sepsis, pneumonia with hypoxia, shock, haemorrhage at diagnosis. Renal failure unconditional for the Lymphoma/Leukemia Heart failure or serious liver. Pulmonary obstructive disease or serious restrictive that not allow to treat the patient with intensive chemotherapy. Secondary Lymphoma after chemotherapy or previous radiotherapy or second malignant tumour. Known hypersensitivity to any foreign protein. Previous treatment with cytostatics of the LLA-B or Burkitt´s Lymphoma (exception: administration on short time of glucocorticoids ≤ 7 days, one administration of vincristine or cyclophosphamide, one cycle of CHOP, urgent administration of the another cytostatics). With another malignant tumour in the last 5 year. Women in fertile age must give positive in the pregnancy test or nursing mother. Mental disability or emotional or psychiatric significant disorder were the patient can't understand nor cooperate with treatment. Patients is enrolled in another clinical research study.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RITUXIMAB<br>* 375 mg/m2/d day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C) |  | 1 year | 
| Prophylactic administration of G-CSF after all chemotherapy cycles |  | 1 year | 
| local irradiation after 6 cycle if CNS was affected or if there are residual tumour |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALL (L3), BURKITT's LYMPHOMA, RITUXIMAB