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Sponsored by: |
PETHEMA Foundation |
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Information provided by: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT00388193 |
The purpose of this clinical trial is to prove the efficacy of the following new regimen treatment:
Condition | Intervention | Phase |
---|---|---|
Acute Lymphoblastic Leukemia Burkitt's Lymphoma |
Drug: RITUXIMAB |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 20 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: RITUXIMAB
375 mg/m2/d day 1
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Clinical Trial with a pharmaceutical speciality in new conditions to use.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Serious complications, uncontrollable, for example, sepsis, pneumonia with hypoxia, shock, haemorrhage at diagnosis.
Contact: Lechado Juan Manuel, CRO | 34 93 238 66 41 | jlechado@seif88.com |
Spain | |
Hospital Clínico Universitario de Salamanca | Recruiting |
Salamanca, Spain | |
Contact: Hernández Rivas José Mª, Dr | |
Principal Investigator: Hernández Rivas José Mª, Dr | |
Hospital general de Jerez de la Frontera | Recruiting |
Jerez de la Frontera, Spain | |
Contact: León Angel, Dr | |
Principal Investigator: León Angel, Dr | |
Hospital Txagorritxu | Recruiting |
Vitoria, Spain | |
Contact: Guinea Josep Mª, Dr | |
Principal Investigator: Guinea José Mª, Dr | |
Complejo Hospitalario de Cáceres | Recruiting |
Cáceres, Spain | |
Contact: Bergua Juan Miguel, Dr | |
Principal Investigator: Bergua Juan Miguel, Dr | |
Hospital General de Alicante | Recruiting |
Alicante, Spain | |
Contact: Fernández Abellán Pascual, Dr | |
Principal Investigator: Fernández Abellán Pascual, Dr | |
Hospital Clínico y Provincial de Barcelona | Recruiting |
Barcelona, Spain | |
Contact: Esteve Jordi, Dr | |
Principal Investigator: Esteve Jordi, Dr | |
Hospital "Santa Creu i Sant Pau" | Recruiting |
Barcelona, Spain | |
Contact: Brunet Salut, Dr | |
Principal Investigator: Brunet Salut, Dr | |
Hospital La Fe | Recruiting |
Valencia, Spain | |
Contact: Sanz Miguel Angel, Dr | |
Principal Investigator: Sanz Miguel Angel, Dr | |
Hospital Clínico San Carlos de Madrid | Recruiting |
Madrid, Spain | |
Contact: Del Potro Eloy, Dr | |
Principal Investigator: Del Potro Eloy, Dr | |
Hospital Doce de Octubre | Recruiting |
Madrid, Spain | |
Contact: Lahuerta Juan José, Dr | |
Principal Investigator: Lahuerta Juan José, ´Dr | |
Hospital Universitario Morales Meseguer, Murcia | Recruiting |
Murcia, Spain | |
Contact: Heras Inmaculada, Dr | |
Principal Investigator: Heras Inmaculada, Dr | |
Hospital Carlos Haya | Recruiting |
Málaga, Spain | |
Contact: Barrios Manuel, Dr | |
Principal Investigator: Barrios Manuel, Dr | |
Hospital Son Dureta | Recruiting |
Palma de Mallorca, Spain | |
Contact: Besalduch Joan, Dr | |
Principal Investigator: Besalduch Joan, Dr | |
Hospital Universitario Virgen del Rocío | Recruiting |
Sevilla, Spain | |
Contact: Ríos Eduardo, Dr | |
Principal Investigator: Ríos Eduardo, Dr | |
Hospital Juan Canalejo | Recruiting |
La Coruña, Spain | |
Contact: Deben Guillermo, Dr | |
Principal Investigator: Deben Guillermo, Dr |
Study Chair: | Ribera Josep Mª, Dr | Hospital Germans Trias i Pujol |
Responsible Party: | pethema ( Pethema ) |
Study ID Numbers: | 2005-001067-64 |
Study First Received: | October 13, 2006 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00388193 |
Health Authority: | Spain: Ministry of Health |
ALL (L3) BURKITT's LYMPHOMA RITUXIMAB |
Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Rituximab Herpesviridae Infections Virus Diseases Lymphoma, B-Cell Burkitt's lymphoma Leukemia |
Lymphatic Diseases B-cell lymphomas Burkitt Lymphoma Epstein-Barr Virus Infections DNA Virus Infections Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Tumor Virus Infections Antirheumatic Agents Pharmacologic Actions Neoplasms, Experimental |