Spots Global Cancer Trial Database for Bendamustine, Cytarabine, Etoposide and Melphalan (BeEAM) as Conditioning for Autologous Stem Cell Transplant (ASCT) in Aggressive Non Hodgkin's Lymphoma (NHL).
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Trial Identification
Brief Title: Bendamustine, Cytarabine, Etoposide and Melphalan (BeEAM) as Conditioning for Autologous Stem Cell Transplant (ASCT) in Aggressive Non Hodgkin's Lymphoma (NHL).
Official Title: Bendamustine, Cytarabine, Etoposide and Melphalan as Conditioning for Autologous Stem Cell Transplant in Patients With Aggressive Non Hodgkin's Lymphoma.
Study ID: NCT01296256
Interventions
Study Description
Brief Summary: The purpose of this study is to determine whether Bendamustine in combination with Etoposide, Cytarabine and Melphalan (BeEAM) are effective as conditioning followed by ASCT in patients with aggressive lymphoma.
Detailed Description: BCNU (carmustine is a nitrosurea alkylating agent used for many years in the conditioning of patients with lymphoma however this drug is hardly available in some countries in Europe, moreover to improve conditioning regimens in autologous stem cell transplant is important because the anti-tumoral effect of high dose therapy are responsible for this procedure efficacy. Although for many years few advances have been achieved in this area now new drugs can be tested in these patients. Bendamustine is a unique cytotoxic agent with structural similarities to alkylating agents and antimetabolites, but which is non-cross-resistant with alkylating agents and other drugs in vitro and in the clinic. Early clinical studies conducted in the German Democratic Republic more than 30 years ago suggested promising activity in indolent non-Hodgkin's lymphoma (NHL). Two North American trials reported responses in more than 70% of patients with chemotherapy- and rituximab-refractory disease, suggesting that bendamustine may be the most effective drug available for this patient population. Response rates of 90% to 92%, with complete remission in 55% to 60%, have been reported in patients with follicular and mantle-cell lymphoma with the combination of bendamustine and rituximab.(Cheson 2009) Leone et all have recently reported results on the characterization of the mechanisms of action of bendamustine and its comparison with structurally related compounds as chlorambucil and phosphoramide mustard have demonstrated that bendamustine displays a distinct mechanisms of action including activation of DNA-damage stress response and apoptosis, inhibition of mitotic checkpoints, and induction of mitotic catastrophe. Also bendamustine activates a base excision DNA repair pathway rather than an alkyltransferase DNA repair mechanism. These data suggest that bendamustine possesses mechanistic features that differentiate it from other alkylating agents and makes this old new drug an attractive one to combine with other agents in the conditioning transplant setting (Leone 2008).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Complejo Hospitalario Universitario de Santiago, Santiago, A Coruña, Spain
Hospital Central de Asturias, Oviedo, Asturias, Spain
Hospital de Jerez, Jerez de la Frontera, CĂĄdiz, Spain
Hospital Son LlĂĄtzer, Palma de Mallorca, Mallorca, Spain
Hospital Universitario Virgen de Arrixaca, El Palmar, Murcia, Spain
Clinica Universitaria de Navarra, Pamplona, Navarra, Spain
Hospital Universitario de Canarias, Santa Cruz de Tenerife, Tenerife, Spain
Hospital Vall dÂŽHebron, Barcelona, , Spain
Hospital Clinic i Provincial, Barcelona, , Spain
H. de la Santa Creu i Sant Pau, Barcelona, , Spain
H.U. 12 de Octubre,, Madrid, , Spain
H.U. Gregorio Marañón,, Madrid, , Spain
H.U. La Paz, Madrid, , Spain
H.U. La Princesa, Madrid, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
H. ClĂnico Universitario de Salamanca, Salamanca, , Spain
H. U. Marqués de Valdecilla., Santander, , Spain
Hospital Clinico de Valencia, Valencia, , Spain
Hospital Arnau de Vilanova, Valencia, , Spain
H. La Fe, Valencia, , Spain
Hospital ClĂnico Lozano Blesa, Zaragoza, , Spain
Contact Details
Name: MÂȘ Dolores Caballero, MD
Affiliation: University of Salamanca
Role: PRINCIPAL_INVESTIGATOR
Name: Alejandro MartĂn, MD
Affiliation: University of Salamanca
Role: PRINCIPAL_INVESTIGATOR
Name: Javier Briones, MD
Affiliation: Hospital Santa Creu i Sant Pau
Role: PRINCIPAL_INVESTIGATOR
Name: Juan Manuel Sancho, MD
Affiliation: Germans Trias i Pujol Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Cristina Barrenetxea, MD
Affiliation: Hospital Vall d'HebrĂłn
Role: PRINCIPAL_INVESTIGATOR
Name: Javier LĂłpez, MD
Affiliation: Hospital Universitario Ramon y Cajal
Role: PRINCIPAL_INVESTIGATOR
Name: MÂȘ JosĂ© RodrĂguez, MD
Affiliation: Hospital Universitario de Canarias
Role: PRINCIPAL_INVESTIGATOR
Name: Jorge Gayoso, MD
Affiliation: Gregorio Marañón Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Miguel Ăngel Canales, MD
Affiliation: Hospital Universitario La Paz
Role: PRINCIPAL_INVESTIGATOR
Name: Carlos Grande, MD
Affiliation: Hospital Universitario 12 de Octubre
Role: PRINCIPAL_INVESTIGATOR
Name: Isidro Jarque, MD
Affiliation: Hospital La Fe
Role: PRINCIPAL_INVESTIGATOR
Name: José Rifón, MD
Affiliation: ClĂnica Universitaria Navarra
Role: PRINCIPAL_INVESTIGATOR
Name: Andres SĂĄnchez, MD
Affiliation: Hospital Virgen de la Arrixaca
Role: PRINCIPAL_INVESTIGATOR
Name: Cristina Castilla, MD
Affiliation: Hospital Morales Meseguer
Role: PRINCIPAL_INVESTIGATOR
Name: José Luis Bello, MD
Affiliation: Complejo Hospitalario Universitario de Santiago de Compostela
Role: PRINCIPAL_INVESTIGATOR
Name: Armando LĂłpez, MD
Affiliation: Hospial ClĂnic de Barcelona
Role: PRINCIPAL_INVESTIGATOR
Name: Eulogio Conde, MD
Affiliation: Hospital Marqués de Valdecilla
Role: PRINCIPAL_INVESTIGATOR
Name: Reyes Arranz, MD
Affiliation: Hospital La Princesa
Role: PRINCIPAL_INVESTIGATOR
Name: EncarnaciĂłn MonzĂł, MD
Affiliation: Hospital Arnau de Vilanova de Valencia
Role: PRINCIPAL_INVESTIGATOR
Name: Rosario Varela, MD
Affiliation: Complejo Hospitalario Universitario de A Coruña
Role: PRINCIPAL_INVESTIGATOR
Name: MÂȘ JosĂ© RamĂrez, MD
Affiliation: Hospital Jerez de la Frontera
Role: PRINCIPAL_INVESTIGATOR
Name: FĂĄtima de la Cruz, MD
Affiliation: Hospital Virgen del RocĂo
Role: PRINCIPAL_INVESTIGATOR
Name: Ana Pilar GonzĂĄlez, MD
Affiliation: Hospital Central de Asturias
Role: PRINCIPAL_INVESTIGATOR
Name: Luis Palomera, MD
Affiliation: Hospital ClĂnico de Zaragoza "Lozano Blesa"
Role: PRINCIPAL_INVESTIGATOR
Name: Raquel del Campo, MD
Affiliation: Hospital Son LlĂĄtzer
Role: PRINCIPAL_INVESTIGATOR
Name: MÂȘ JosĂ© Terol, MD
Affiliation: Hospital ClĂnico de Valencia
Role: PRINCIPAL_INVESTIGATOR
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