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The purpose of this clinical trial is to prove the efficacy of the following new regimen treatment:
Clinical Trial with a pharmaceutical speciality in new conditions to use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RITUXIMAB | Drug | 375 mg/m2/d day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Serious complications, uncontrollable, for example, sepsis, pneumonia with hypoxia, shock, haemorrhage at diagnosis.
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| Name | Affiliation | Role |
|---|---|---|
| Ribera Josep Mª, Dr | Germans Trias i Pujol Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Alicante | Alicante | Alicante | Spain | |||
| Hospital "Santa Creu i Sant Pau" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8555471 | Background | Hoelzer D, Ludwig WD, Thiel E, Gassmann W, Loffler H, Fonatsch C, Rieder H, Heil G, Heinze B, Arnold R, Hossfeld D, Buchner T, Koch P, Freund M, Hiddemann W, Maschmeyer G, Heyll A, Aul C, Faak T, Kuse R, Ittel TH, Gramatzki M, Diedrich H, Kolbe K, Fuhr HG, Fischer K, Schadeck-Gressel C, Weiss A, Strohscheer I, Metzner B, Fabry U, Gokbuget N, Volkers B, Messerer D, Uberla K. Improved outcome in adult B-cell acute lymphoblastic leukemia. Blood. 1996 Jan 15;87(2):495-508. | |
| 10552938 |
| Label | URL |
|---|---|
| Spanish association of Haematology | View source |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| local irradiation after 6 cycle if CNS was affected or if there are residual tumour | 1 year |
| Barcelona |
| Barcelona |
| Spain |
| Hospital Clínico y Provincial de Barcelona | Barcelona | Barcelona | Spain |
| Hospital Juan Canalejo | A Coruña | La Coruña | Spain |
| Hospital Clínico San Carlos de Madrid | Madrid | Madrid | Spain |
| Hospital Doce de Octubre | Madrid | Madrid | Spain |
| Hospital Universitario Morales Meseguer, Murcia | Murcia | Murcia | Spain |
| Hospital Carlos Haya | Málaga | Málaga | Spain |
| Hospital Son Dureta | Palma de Mallorca | Palma de Mallorca | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Sevilla | Spain |
| Hospital La Fe | Valencia | Valencia | Spain |
| Complejo Hospitalario de Cáceres | Cáceres | Spain |
| Hospital general de Jerez de la Frontera | Jerez de la Frontera | Spain |
| Hospital Clínico Universitario de Salamanca | Salamanca | Spain |
| Hospital Txagorritxu | Vitoria-Gasteiz | Spain |
| Background |
| Reiter A, Schrappe M, Tiemann M, Ludwig WD, Yakisan E, Zimmermann M, Mann G, Chott A, Ebell W, Klingebiel T, Graf N, Kremens B, Muller-Weihrich S, Pluss HJ, Zintl F, Henze G, Riehm H. Improved treatment results in childhood B-cell neoplasms with tailored intensification of therapy: A report of the Berlin-Frankfurt-Munster Group Trial NHL-BFM 90. Blood. 1999 Nov 15;94(10):3294-306. |
| 10561310 | Background | Thomas DA, Cortes J, O'Brien S, Pierce S, Faderl S, Albitar M, Hagemeister FB, Cabanillas FF, Murphy S, Keating MJ, Kantarjian H. Hyper-CVAD program in Burkitt's-type adult acute lymphoblastic leukemia. J Clin Oncol. 1999 Aug;17(8):2461-70. doi: 10.1200/JCO.1999.17.8.2461. |
| 9578060 | Background | Adde M, Shad A, Venzon D, Arndt C, Gootenberg J, Neely J, Nieder M, Owen W, Seibel N, Wilson W, Horak ID, Magrath I. Additional chemotherapy agents improve treatment outcome for children and adults with advanced B-cell lymphomas. Semin Oncol. 1998 Apr;25(2 Suppl 4):33-9; discussion 45-8. |
| 12576316 | Background | Mounier N, Briere J, Gisselbrecht C, Emile JF, Lederlin P, Sebban C, Berger F, Bosly A, Morel P, Tilly H, Bouabdallah R, Reyes F, Gaulard P, Coiffier B. Rituximab plus CHOP (R-CHOP) overcomes bcl-2--associated resistance to chemotherapy in elderly patients with diffuse large B-cell lymphoma (DLBCL). Blood. 2003 Jun 1;101(11):4279-84. doi: 10.1182/blood-2002-11-3442. Epub 2003 Feb 6. |
| 11600602 | Background | Lee EJ, Petroni GR, Schiffer CA, Freter CE, Johnson JL, Barcos M, Frizzera G, Bloomfield CD, Peterson BA. Brief-duration high-intensity chemotherapy for patients with small noncleaved-cell lymphoma or FAB L3 acute lymphocytic leukemia: results of cancer and leukemia group B study 9251. J Clin Oncol. 2001 Oct 15;19(20):4014-22. doi: 10.1200/JCO.2001.19.20.4014. |
| 10552937 | Background | Zinzani PL, Martelli M, Magagnoli M, Pescarmona E, Scaramucci L, Palombi F, Bendandi M, Martelli MP, Ascani S, Orcioni GF, Pileri SA, Mandelli F, Tura S. Treatment and clinical management of primary mediastinal large B-cell lymphoma with sclerosis: MACOP-B regimen and mediastinal radiotherapy monitored by (67)Gallium scan in 50 patients. Blood. 1999 Nov 15;94(10):3289-93. |
| 12681972 | Background | Oriol A, Ribera JM, Esteve J, Sanz MA, Brunet S, Garcia-Boyero R, Fernandez-Abellan P, Marti JM, Abella E, Sanchez-Delgado M, Penarrubia MJ, Besalduch J, Moreno MJ, Borrego D, Feliu E, Ortega JJ; PETHEMA Group, Spanish Society of Hematology. Lack of influence of human immunodeficiency virus infection status in the response to therapy and survival of adult patients with mature B-cell lymphoma or leukemia. Results of the PETHEMA-LAL3/97 study. Haematologica. 2003 Apr;88(4):445-53. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |