Status:
COMPLETED
Rituximab Combined With Chemotherapy in Burkitt's Lymphoma
Lead Sponsor:
PETHEMA Foundation
Conditions:
Acute Lymphoblastic Leukemia
Burkitt's Lymphoma
Eligibility:
All Genders
15+ years
Phase:
PHASE2
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 hig...
Detailed Description
Clinical Trial with a pharmaceutical speciality in new conditions to use.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00388193
Start Date
August 1 2006
End Date
December 1 2013
Last Update
October 28 2014
Active Locations (15)
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1
Hospital General de Alicante
Alicante, Alicante, Spain
2
Hospital "Santa Creu i Sant Pau"
Barcelona, Barcelona, Spain
3
Hospital Clínico y Provincial de Barcelona
Barcelona, Barcelona, Spain
4
Hospital Juan Canalejo
A Coruña, La Coruña, Spain