Rituximab Combined With Chemotherapy in Burkitt's Lymphoma
- Conditions
- Acute Lymphoblastic LeukemiaBurkitt's Lymphoma
- Interventions
- Registration Number
- NCT00388193
- Lead Sponsor
- PETHEMA Foundation
- Brief Summary
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
Clinical Trial with a pharmaceutical speciality in new conditions to use.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 RITUXIMAB -
- Primary Outcome Measures
Name Time Method Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy. 1 year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (15)
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital Clínico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Juan Canalejo
🇪🇸La Coruña, Spain
Hospital Doce de Octubre
🇪🇸Madrid, Spain
Hospital Clínico San Carlos de Madrid
🇪🇸Madrid, Spain
Hospital general de Jerez de la Frontera
🇪🇸Jerez de la Frontera, Spain
Hospital Txagorritxu
🇪🇸Vitoria, Spain
Hospital "Santa Creu i Sant Pau"
🇪🇸Barcelona, Spain
Hospital Clínico y Provincial de Barcelona
🇪🇸Barcelona, Spain
Complejo Hospitalario de Cáceres
🇪🇸Cáceres, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Son Dureta
🇪🇸Palma de Mallorca, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Hospital Universitario Morales Meseguer, Murcia
🇪🇸Murcia, Spain
Hospital Carlos Haya
🇪🇸Málaga, Spain