R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT01133158
- Lead Sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- Age ≥ 18 and ≤ 75 years.
- 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.
- 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).
- ECOG ≤ 2.
- Signed written informed consent.
- Clinical suspicion or documentation of histological transformation.
- Have received prior chemotherapy scheme, first line without Rituximab.
- Prior autologous or allogeneic.
- CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis).
- Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA)
- HCV infection. HIV infection or other conditions of serious immunosuppression.
- Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated.
- Cardiac function in cardiac patient known or prior treatment with anthracyclines with EF <50%.
- Impaired renal function (creatinine> 1.5 x Upper Limit of Normal, LSN) or a creatinine clearance <50 ml / h, not related to lymphoma.
- Impaired liver function (bilirubin, AST / ALT or GGT> 2 x ULN) were not related to lymphoma.
- 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.
- Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma.
- Severe acute or chronic infection in activity.
- Any other concurrent medical or psychological comorbidity that might interfere with participation in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description R-BMD Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years
- Primary Outcome Measures
Name Time Method Response Rate 7 years The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL
Complete Remission (CR):
Nodes returned to normal (if GTD \>15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 and SA \>10 mm before therapy, SA now ≤10 mm) All (non-nodal) target lesions completely resolved
Partial Remission (PR) SPD of target lesions decreased ≥50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD
Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD
Progressive Disease (PD):
SPD increase ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion
- Secondary Outcome Measures
Name Time Method Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response. 7 years
Trial Locations
- Locations (41)
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago, A Coruña, Spain
Hospital Universitario Virgen de Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital Txagorritxu
🇪🇸Vitoria, Alava, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital de Galdakao
🇪🇸Galdakao, Bilbao, Spain
Hospital Virgen de la Concha
🇪🇸Zamora, Spain
Hospital General de Valencia
🇪🇸Valencia, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Vall d´Hebron
🇪🇸Barcelona, Spain
Hospital Río Hortega
🇪🇸Valladolid, Spain
Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Mallorca, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Clínico de Zaragoza
🇪🇸Zaragoza, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital de Getafe
🇪🇸Getafe, Madrid, Spain
Hospital Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Hospital Fundación de Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Hospital Son Llàtzer
🇪🇸Palma de Mallorca, Mallorca, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Hospital de Jaén
🇪🇸Jaén, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Tenerife, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital San Pedro Alcántara
🇪🇸Cáceres, Spain
Hospital Puerta del Mar
🇪🇸Cádiz, Spain
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Morales Meseguer
🇪🇸Murcia, Spain
Complejo Hospitalario Carlos Haya
🇪🇸Málaga, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital de Salamanca
🇪🇸Salamanca, Spain
Hospital General de Segovia
🇪🇸Segovia, Spain
Hospital de Jerez
🇪🇸Jerez de la Frontera, Cádiz, Spain
Hospital San Juan de Alicante
🇪🇸San Juan de Alicante, Alicante, Spain