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R-BMD GELTAMO Relapsed Lymphoma

Information source: Grupo EspaŮol de Linfomas y Transplante Autůlogo de Mťdula ”sea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Hodgkin's Lymphoma

Intervention: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Grupo EspaŮol de Linfomas y Transplante Autůlogo de Mťdula ”sea

Official(s) and/or principal investigator(s):
Francisco Javier Pe√Īalver P√°rraga, MD, Principal Investigator, Affiliation: Hospital Fundaci√≥n de Alcorcon
Javier De la Serna Torroba, MD, Principal Investigator, Affiliation: Hospital 12 de Octubre
Jose Antonio García Vela, MD, Principal Investigator, Affiliation: Hospital de Getafe
Patricia Font L√≥pez, MD, Principal Investigator, Affiliation: Hospital Gregorio Mara√Ī√≥n
Secundino Ferrer Bordas, MD, Principal Investigator, Affiliation: Hospital Dr. Peset
Encarnación Monzó Castellano, MD, Principal Investigator, Affiliation: Hospital Arnau de Vilanova
Eulogio Conde García, MD, Principal Investigator, Affiliation: Hospital Marqués de Valdecilla
José Antonio Márquez Navarro, MD, Principal Investigator, Affiliation: Hospital de Basurto
Ernesto Pérez Persona, MD, Principal Investigator, Affiliation: Hospital Txagorritxu
Garazi Letamendi Madariaga, MD, Principal Investigator, Affiliation: Hospital de Galdakao
Pilar Giraldo Castellanos, MD, Principal Investigator, Affiliation: Hospital Miguel Servet
Luis Palomera, MD, Principal Investigator, Affiliation: Hospital Clínico de Zaragoza
Andr√©s L√≥pez Hern√°ndez, MD, Principal Investigator, Affiliation: Hospital Vall d¬īHebron
Blanca S√°nchez, MD, Principal Investigator, Affiliation: Hospital del Mar
José Luis Sánchez-Majado, MD, Principal Investigator, Affiliation: Hospital San Juan de Alicante
Antonio Gutiérrez García, MD, Principal Investigator, Affiliation: Hospital Son Espases
Francisco Javier Capote Huelva, MD, Principal Investigator, Affiliation: Hospital Puerta del Mar
Ana Marín Niebla, MD, Principal Investigator, Affiliation: Hospital Virgen del Rocío
Mª José Ramírez, MD, Principal Investigator, Affiliation: Hospital de Jerez
Fernando Carnicero Gonz√°lez, MD, Principal Investigator, Affiliation: Hospital San Pedro de Alc√°ntara
Mª José Rodríguez Salazar, MD, Principal Investigator, Affiliation: Hospital Universitario de Canarias
Miguel √Āngel Canales Albendea, MD, Principal Investigator, Affiliation: Hospital La Paz
José Antonio García Marco, MD, Principal Investigator, Affiliation: Hospital Puerta de Hierro
Carlos Montalb√°n Sanz, MD, Principal Investigator, Affiliation: Hospital Universitario Ramon y Cajal
Rosalía Riaza Grau, MD, Principal Investigator, Affiliation: Hospital Severo Ochoa
Mª Dolores Caballero Barrigón, MD, Principal Investigator, Affiliation: Hospital de Salamanca
M¬™ Jes√ļs Pe√Īarrubia Ponce, MD, Principal Investigator, Affiliation: Hospital R√≠o Hortega
José Antonio Queizán, MD, Principal Investigator, Affiliation: Hospital de Segovia
Roberto Hernández Martín, MD, Principal Investigator, Affiliation: Hospital Virgen de la Concha
Mª José Terol Castera, MD, Principal Investigator, Affiliation: Hospital Clínico de Valencia
Félix Carbonell, MD, Principal Investigator, Affiliation: Hospital General de Valencia
Rosario Varela G√≥mez, MD, Principal Investigator, Affiliation: Complejo Hospitalario A Coru√Īa
José Luis Bello López, MD, Principal Investigator, Affiliation: C. H. U. Santiago
Carlos Panizo, MD, Principal Investigator, Affiliation: Clínica Universitaria de Navarra
Juan Manuel Sancho CIa, MD, Principal Investigator, Affiliation: Germans Trias i Pujol Hospital
Armando López Guillermo, MD, Principal Investigator, Affiliation: Hospital Clínic i Provincial
Elena Pérez Ceballos, MD, Principal Investigator, Affiliation: Hospital Morales Meseguer
Andrés Sánchez Salinas, MD, Principal Investigator, Affiliation: Hospital Universitario Virgen de la Arrixaca
Mª Soledad Durán Nieto, MD, Principal Investigator, Affiliation: Hospital de Jaén
Manuel Espeso de Haro, MD, Principal Investigator, Affiliation: Hospital Carlos Haya
Joan Bargay Lleonart, MD, Principal Investigator, Affiliation: Hospital Son Llàtzer

Summary

Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.

Clinical Details

Official title: Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (R-BMD) in Patients With Follicular Lymphoma Refractory or Relapsed

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary endpoint is the complete response and unconfirmed complete response according to the criteria of the International Workshop to Standardize Response Criteria for NHL

Secondary outcome:

Secondary endpoints included an assessment of the following parameters:Global Survival, Progression-Free Survival, Disease-Free Survival,Duration of the Response.

Security of bendamustine in combination with dexamethasone,Mitoxantrone and Rituximab.

Detailed description: Assess the combination of efficacy and safety of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma who are refractory or in relapse.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age ‚Č• 18 and ‚ȧ 75 years. 2. Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue. Be accepted diagnosis in bone marrow if no accessible lymph nodes and whether it has discarded the mantle LLC, and NHL. 3. Follicular lymphoma patients treated with the combination of rituximab and chemotherapy in first line, which have been refractory or relapsed after having achieved any responses to this first line of pretreatment (excluding radiotherapy). 4. ECOG ‚ȧ 2. 5. Signed written informed consent. Exclusion Criteria: 1. Clinical suspicion or documentation of histological transformation. 2. Have received prior chemotherapy scheme, first line without Rituximab. 3. Prior autologous or allogeneic. 4. CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis). 5. Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA) 6. HCV infection. HIV infection or other conditions of serious immunosuppression. 7. Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated. 8. Cardiac function in cardiac patient known or prior treatment with anthracyclines with EF <50%. 9. Impaired renal function (creatinine> 1. 5 x Upper Limit of Normal, LSN) or a creatinine clearance <50 ml / h, not related to lymphoma. 10. Impaired liver function (bilirubin, AST / ALT or GGT> 2 x ULN) were not related to lymphoma. 11. Women who are nursing or pregnant. Women of childbearing potential will be included prior pregnancy test serum / urine negative. Use effective contraception to be kept for 1 year after cessation of rituximab. 12. Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma. 13. Severe acute or chronic infection in activity. 14. Any other concurrent medical or psychological comorbidity that might interfere with participation in this study.

Locations and Contacts

Complejo Hospitalario Universitario A Coru√Īa, A Coru√Īa 15006, Spain

Hospital Clinic i Provincial, Barcelona 08036, Spain

Hospital del Mar, Barcelona 08003, Spain

Hospital Vall d¬īHebron, Barcelona 08035, Spain

Hospital de Basurto, Bilbao 48013, Spain

Hospital San Pedro Alc√°ntara, C√°ceres 10002, Spain

Hospital Puerta del Mar, C√°diz 11009, Spain

Hospital de Jaén, Jaén 23007, Spain

Hospital 12 de Octubre, Madrid 28041, Spain

Hospital Gregorio Mara√Ī√≥n, Madrid 28009, Spain

Hospital La Paz, Madrid 28046, Spain

Hospital Ramón y Cajal, Madrid 28034, Spain

Hospital Morales Meseguer, Murcia 30008, Spain

Complejo Hospitalario Carlos Haya, M√°laga 29010, Spain

Hospital de Salamanca, Salamanca 37007, Spain

Hospital General de Segovia, Segovia 42002, Spain

Hospital Virgen del Rocío, Sevilla 41013, Spain

Hospital Arnau de Vilanova, Valencia 46015, Spain

Hospital Clínico Universitario de Valencia, Valencia 46010, Spain

Hospital General de Valencia, Valencia 46014, Spain

Hospital Universitario Dr. Peset, Valencia 46017, Spain

Hospital Río Hortega, Valladolid 47012, Spain

Hospital Virgen de la Concha, Zamora 49022, Spain

Hospital Clínico de Zaragoza, Zaragoza 50009, Spain

Hospital Miguel Servet, Zaragoza 50009, Spain

Complejo Hospitalario Universitario de Santiago, Santiago, A Coru√Īa 15706, Spain

Hospital Txagorritxu, Vitoria, Alava 01009, Spain

Hospital San Juan de Alicante, San Juan de Alicante, Alicante 03550, Spain

Hospital Germans Trias i Pujol, Badalona, Barcelona 08916, Spain

Hospital de Galdakao, Galdakao, Bilbao 48960, Spain

Hospital Marqués de Valdecilla, Santander, Cantabria 39008, Spain

Hospital de Jerez, Jerez de la Frontera, C√°diz 11407, Spain

Hospital Fundación de Alcorcón, Alcorcón, Madrid 289222, Spain

Hospital de Getafe, Getafe, Madrid 28901, Spain

Hospital Severo Ochoa, Leganés, Madrid 28911, Spain

Hospital Puerta de Hierro, Majadahonda, Madrid 28222, Spain

Hospital Son Espases, Palma de Mallorca, Mallorca 07014, Spain

Hospital Son Llàtzer, Palma de Mallorca, Mallorca 07010, Spain

Hospital Universitario Virgen de Arrixaca, El Palmar, Murcia 30120, Spain

Clínica Universitaria de Navarra, Pamplona, Navarra 31008, Spain

Hospital Universitario de Canarias, La Laguna, Tenerife 38320, Spain

Additional Information

Starting date: July 2009
Last updated: April 16, 2015

Page last updated: August 23, 2015

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