Rituximab Combined With Chemotherapy in Burkitt's Lymphoma
NCT ID: NCT00388193
Last Updated: 2014-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2006-08-31
2013-12-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
RITUXIMAB
375 mg/m2/d day 1
Interventions
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RITUXIMAB
375 mg/m2/d day 1
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with Burkitt´s and Burkitt´s Like Lymphoma
* Patients 15 years old or up
* Written Informed Consent signed
Exclusion Criteria
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.
15 Years
ALL
No
Sponsors
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PETHEMA Foundation
OTHER
Responsible Party
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Principal Investigators
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Ribera Josep Mª, Dr
Role: STUDY_CHAIR
Germans Trias i Pujol Hospital
Locations
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Hospital General de Alicante
Alicante, Alicante, Spain
Hospital "Santa Creu i Sant Pau"
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
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Spanish association of Haematology
Other Identifiers
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2005-001067-64
Identifier Type: -
Identifier Source: org_study_id
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