Clinical trial NCT01133158: R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: Follicular non-Hodgkin's lymphoma relapse refractory
Lead sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor class: OTHER
First posted: 2010-05-28
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Response Rate
timeFrame: 7 years
Secondary outcomes:
measure: Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.
timeFrame: 7 years
Other outcomes:
Locations:
city: Santiago
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: A Coruña
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
state: Alava
city: San Juan de Alicante
country: Spain
facility: Hospital San Juan de Alicante
state: Alicante
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Galdakao
country: Spain
facility: Hospital de Galdakao
state: Bilbao
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
state: Cantabria
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez
state: Cádiz
city: Alcorcón
country: Spain
facility: Hospital Fundación de Alcorcón
state: Madrid
city: Getafe
country: Spain
facility: Hospital de Getafe
state: Madrid
city: Leganés
country: Spain
facility: Hospital Severo Ochoa
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer
state: Mallorca
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Mallorca
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de Arrixaca
state: Murcia
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Cáceres
country: Spain
facility: Hospital San Pedro Alcántara
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Jaén
country: Spain
facility: Hospital de Jaén
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Málaga
country: Spain
facility: Complejo Hospitalario Carlos Haya
city: Salamanca
country: Spain
facility: Hospital de Salamanca
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valladolid
country: Spain
facility: Hospital Río Hortega
city: Zamora
country: Spain
facility: Hospital Virgen de la Concha
city: Zaragoza
country: Spain
facility: Hospital Clínico de Zaragoza
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Universitario Fundación Alcorcón
name: Francisco Javier Peñalver Párraga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital 12 de Octubre
name: Javier De la Serna Torroba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Getafe.
name: Francisca Oña Compan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gregorio Marañón Hospital
name: Patricia Font López, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Dr. Peset
name: Secundino Ferrer Bordas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Arnau de Vilanova
name: José Ramón Mayans Ferrer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Marqués de Valdecilla
name: Eulogio Conde García, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Basurto
name: José Antonio Márquez Navarro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Txagorritxu
name: Ernesto Pérez Persona, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Galdakao
name: Garazi Letamendi Madariaga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Miguel Servet
name: Pilar Giraldo Castellanos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico de Zaragoza
name: Luis Palomera Bernal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vall d´Hebron
name: Andrés López Hernández, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: Blanca Sánchez González, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Juan de Alicante
name: José Luis Sánchez-Majado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Espases
name: Antonio Gutiérrez García, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Puerta del Mar
name: Francisco Javier Capote Huelva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen del Rocío
name: Fátima de la Cruz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Jerez
name: Mª José Ramírez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Pedro de Alcantara
name: Fernando Carnicero González, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Canarias
name: Mª José Rodríguez Salazar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital La Paz
name: Miguel Ángel Canales Albendea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Puerta de Hierro
name: José Antonio García Marco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ramon y Cajal
name: Carlos Montalbán Sanz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Severo Ochoa
name: Rosalía Riaza Grau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Salamanca
name: Mª Dolores Caballero Barrigón, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Río Hortega
name: Mª Jesús Peñarrubia Ponce, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Segovia
name: José Antonio Queizán, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de la Concha
name: Roberto Hernández Martín, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico de Valencia
name: Mª José Terol Castera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario de Valencia
name: Félix Carbonell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario A Coruña
name: María Rosario Varela Gómez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: C. H. U. Santiago
name: José Luis Bello López, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Universitaria de Navarra
name: Carlos Panizo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Juan Manuel Sancho Cia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínic i Provincial
name: Armando López Guillermo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Morales Meseguer
name: Elena Pérez Ceballos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Andrés Sánchez Salinas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Jaén
name: Mª Soledad Durán Nieto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Carlos Haya
name: Manuel Espeso de Haro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Llàtzer
name: Joan Bargay Lleonart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penalver FJ, Marquez JA, Duran S, Giraldo P, Martin A, Montalban C, Sancho JM, Ramirez MJ, Terol MJ, Capote FJ, Gutierrez A, Sanchez B, Lopez A, Salar A, Rodriguez-Caravaca G, Canales M, Caballero MD; GELTAMO (The Spanish Lymphoma Cooperative Group). Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial. Cancer Med. 2019 Nov;8(16):6955-6966. doi: 10.1002/cam4.2555. Epub 2019 Oct 1.