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Rituximab Combined With Chemotherapy in Burkitt`s Lymphoma
This study is currently recruiting participants.
Verified by PETHEMA Foundation, November 2008
Sponsored by: PETHEMA Foundation
Information provided by: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00388193
  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 II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources
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)

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
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

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

Contacts
Contact: Lechado Juan Manuel, CRO 34 93 238 66 41 jlechado@seif88.com

Locations
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            
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Chair: Ribera Josep Mª, Dr Hospital Germans Trias i Pujol
  More Information

Pethema Foundation web  This link exits the ClinicalTrials.gov site
Spanish association of Haematology  This link exits the ClinicalTrials.gov site

Publications:
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.
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. 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. Review.
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.

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

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009