R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial
Launched by GRUPO ESPAÑOL DE LINFOMAS Y TRANSPLANTE AUTÓLOGO DE MÉDULA ÓSEA · May 27, 2010
Trial Information
Current as of May 05, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age ≥ 18 and ≤ 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 ≤ 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.
About Grupo Español De Linfomas Y Transplante Autólogo De Médula ósea
The Grupo Español de Linfomas y Trasplante Autólogo de Médula Ósea (GELTAMO) is a prominent Spanish clinical research organization dedicated to advancing the understanding and treatment of lymphomas and hematological malignancies. Composed of a network of leading hematologists and oncologists, GELTAMO focuses on conducting innovative clinical trials, fostering collaboration among healthcare professionals, and implementing best practices in patient care. By prioritizing research excellence and patient-centered approaches, GELTAMO aims to improve therapeutic outcomes and enhance the quality of life for patients undergoing autologous stem cell transplantation and related treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
Zaragoza, , Spain
Madrid, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
A Coruña, , Spain
Bilbao, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Murcia, , Spain
La Laguna, Tenerife, Spain
Badalona, Barcelona, Spain
Sevilla, , Spain
Barcelona, , Spain
Cádiz, , Spain
Leganés, Madrid, Spain
Jaén, , Spain
Jerez De La Frontera, Cádiz, Spain
Vitoria, Alava, Spain
Santander, Cantabria, Spain
Pamplona, Navarra, Spain
Getafe, Madrid, Spain
Majadahonda, Madrid, Spain
Zaragoza, , Spain
Salamanca, , Spain
Santiago, A Coruña, Spain
San Juan De Alicante, Alicante, Spain
Galdakao, Bilbao, Spain
Alcorcón, Madrid, Spain
Palma De Mallorca, Mallorca, Spain
Palma De Mallorca, Mallorca, Spain
El Palmar, Murcia, Spain
Cáceres, , Spain
Madrid, , Spain
Málaga, , Spain
Segovia, , Spain
Valladolid, , Spain
Zamora, , Spain
Patients applied
Trial Officials
Francisco Javier Peñalver Párraga, MD
Principal Investigator
Hospital Universitario Fundación Alcorcón
Javier De la Serna Torroba, MD
Principal Investigator
Hospital 12 de Octubre
Francisca Oña Compan, MD
Principal Investigator
Hospital de Getafe.
Patricia Font López, MD
Principal Investigator
Gregorio Marañón Hospital
Secundino Ferrer Bordas, MD
Principal Investigator
Hospital Dr. Peset
José Ramón Mayans Ferrer, MD
Principal Investigator
Hospital Arnau de Vilanova
Eulogio Conde García, MD
Principal Investigator
Hospital Marqués de Valdecilla
José Antonio Márquez Navarro, MD
Principal Investigator
Hospital de Basurto
Ernesto Pérez Persona, MD
Principal Investigator
Hospital Txagorritxu
Garazi Letamendi Madariaga, MD
Principal Investigator
Hospital de Galdakao
Pilar Giraldo Castellanos, MD
Principal Investigator
Hospital Miguel Servet
Luis Palomera Bernal, MD
Principal Investigator
Hospital Clínico de Zaragoza
Andrés López Hernández, MD
Principal Investigator
Hospital Vall d´Hebron
Blanca Sánchez González, MD
Principal Investigator
Hospital del Mar
José Luis Sánchez-Majado, MD
Principal Investigator
Hospital San Juan de Alicante
Antonio Gutiérrez García, MD
Principal Investigator
Hospital Son Espases
Francisco Javier Capote Huelva, MD
Principal Investigator
Hospital Universitario Puerta del Mar
Fátima de la Cruz, MD
Principal Investigator
Hospital Virgen del Rocío
Mª José Ramírez, MD
Principal Investigator
Hospital de Jerez
Fernando Carnicero González, MD
Principal Investigator
Hospital San Pedro de Alcantara
Mª José Rodríguez Salazar, MD
Principal Investigator
Hospital Universitario de Canarias
Miguel Ángel Canales Albendea, MD
Principal Investigator
Hospital La Paz
José Antonio García Marco, MD
Principal Investigator
Hospital Puerta de Hierro
Carlos Montalbán Sanz, MD
Principal Investigator
Hospital Universitario Ramon y Cajal
Rosalía Riaza Grau, MD
Principal Investigator
Hospital Severo Ochoa
Mª Dolores Caballero Barrigón, MD
Principal Investigator
Hospital de Salamanca
Mª Jesús Peñarrubia Ponce, MD
Principal Investigator
Hospital Río Hortega
José Antonio Queizán, MD
Principal Investigator
Hospital de Segovia
Roberto Hernández Martín, MD
Principal Investigator
Hospital Virgen de la Concha
Mª José Terol Castera, MD
Principal Investigator
Hospital Clínico de Valencia
Félix Carbonell, MD
Principal Investigator
Hospital General Universitario de Valencia
María Rosario Varela Gómez, MD
Principal Investigator
Complejo Hospitalario A Coruña
José Luis Bello López, MD
Principal Investigator
C. H. U. Santiago
Carlos Panizo, MD
Principal Investigator
Clínica Universitaria de Navarra
Juan Manuel Sancho Cia, MD
Principal Investigator
Germans Trias i Pujol Hospital
Armando López Guillermo, MD
Principal Investigator
Hospital Clínic i Provincial
Elena Pérez Ceballos, MD
Principal Investigator
Hospital Morales Meseguer
Andrés Sánchez Salinas, MD
Principal Investigator
Hospital Universitario Virgen de la Arrixaca
Mª Soledad Durán Nieto, MD
Principal Investigator
Hospital de Jaén
Manuel Espeso de Haro, MD
Principal Investigator
Hospital Carlos Haya
Joan Bargay Lleonart, MD
Principal Investigator
Hospital Son Llàtzer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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