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Rituximab Combined With Chemotherapy in Burkitt`s Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00388193
First received: October 13, 2006
Last updated: October 27, 2014
Last verified: February 2013
  Purpose

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 Intervention Phase
Acute Lymphoblastic Leukemia
Burkitt's Lymphoma
Drug: RITUXIMAB
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Prophylactic administration of G-CSF after all chemotherapy cycles [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • local irradiation after 6 cycle if CNS was affected or if there are residual tumour [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2006
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RITUXIMAB
375 mg/m2/d day 1

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388193

Locations
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
Study Chair: Ribera Josep Mª, Dr Germans Trias i Pujol Hospital
  More Information

Additional Information:
Publications:

Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00388193     History of Changes
Other Study ID Numbers: 2005-001067-64
Study First Received: October 13, 2006
Last Updated: October 27, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by PETHEMA Foundation:
ALL (L3)
BURKITT's LYMPHOMA
RITUXIMAB

Additional relevant MeSH terms:
Burkitt Lymphoma
Leukemia, Lymphoid
Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
DNA Virus Infections
Epstein-Barr Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Experimental
Tumor Virus Infections
Virus Diseases
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014