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Rituximab Combined With Chemotherapy in Burkitt's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00388193
Recruitment Status : Completed
First Posted : October 16, 2006
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation

Study Description
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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

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Burkitt's Lymphoma Drug: RITUXIMAB Phase 2

Detailed Description:
Clinical Trial with a pharmaceutical speciality in new conditions to use.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Burkimab:Study Multicenter of Optimization of the Treatment of LLA-B and the Burkitt's Lymphoma in Adult Patients (From 15 Years Old)
Study Start Date : August 2006
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: RITUXIMAB
375 mg/m2/d day 1


Outcome Measures
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Primary Outcome Measures :
  1. Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C) [ Time Frame: 1 year ]
  2. Prophylactic administration of G-CSF after all chemotherapy cycles [ Time Frame: 1 year ]
  3. local irradiation after 6 cycle if CNS was affected or if there are residual tumour [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388193


Locations
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Spain
Hospital General de Alicante
Alicante, Spain
Hospital "Santa Creu i Sant Pau"
Barcelona, Spain
Hospital Clínico y Provincial de Barcelona
Barcelona, Spain
Complejo Hospitalario de Cáceres
Cáceres, Spain
Hospital general de Jerez de la Frontera
Jerez de la Frontera, Spain
Hospital Juan Canalejo
La Coruña, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Spain
Hospital Doce de Octubre
Madrid, Spain
Hospital Universitario Morales Meseguer, Murcia
Murcia, Spain
Hospital Carlos Haya
Málaga, Spain
Hospital Son Dureta
Palma de Mallorca, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Hospital La Fe
Valencia, Spain
Hospital Txagorritxu
Vitoria, Spain
Sponsors and Collaborators
PETHEMA Foundation
Investigators
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Study Chair: Ribera Josep Mª, Dr Germans Trias i Pujol Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00388193    
Other Study ID Numbers: 2005-001067-64
First Posted: October 16, 2006    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: February 2013
Keywords provided by PETHEMA Foundation:
ALL (L3)
BURKITT's LYMPHOMA
RITUXIMAB
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Epstein-Barr Virus Infections
 Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents