R-BMD GELTAMO Relapsed Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Information provided by:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT01133158
First received: February 11, 2010
Last updated: October 30, 2012
Last verified: October 2012
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Purpose
Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Bendamustine hydrochloride
Bendamustine
Mitoxantrone
Mitoxantrone hydrochloride
Rituximab
U.S. FDA Resources
Further study details as provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
Primary Outcome Measures:
- 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 [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Secondary endpoints included an assessment of the following parameters:Global Survival, Progression-Free Survival, Disease-Free Survival,Duration of the Response. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- Security of bendamustine in combination with dexamethasone,Mitoxantrone and Rituximab. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone |
Drug: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133158
Locations
| Spain | |
| Complejo Hospitalario Universitario de Santiago | |
| Santiago, A Coruña, Spain, 15706 | |
| Hospital Txagorritxu | |
| Vitoria, Alava, Spain, 01009 | |
| Hospital San Juan de Alicante | |
| San Juan de Alicante, Alicante, Spain, 03550 | |
| Hospital Germans Trias i Pujol | |
| Badalona, Barcelona, Spain, 08916 | |
| Hospital de Galdakao | |
| Galdakao, Bilbao, Spain, 48960 | |
| Hospital Marqués de Valdecilla | |
| Santander, Cantabria, Spain, 39008 | |
| Hospital de Jerez | |
| Jerez de la Frontera, Cádiz, Spain, 11407 | |
| Hospital Fundación de Alcorcón | |
| Alcorcón, Madrid, Spain, 289222 | |
| Hospital de Getafe | |
| Getafe, Madrid, Spain, 28901 | |
| Hospital Severo Ochoa | |
| Leganés, Madrid, Spain, 28911 | |
| Hospital Puerta de Hierro | |
| Majadahonda, Madrid, Spain, 28222 | |
| Hospital Son Espases | |
| Palma de Mallorca, Mallorca, Spain, 07014 | |
| Hospital Son Llàtzer | |
| Palma de Mallorca, Mallorca, Spain, 07010 | |
| Hospital Universitario Virgen de Arrixaca | |
| El Palmar, Murcia, Spain, 30120 | |
| Clínica Universitaria de Navarra | |
| Pamplona, Navarra, Spain, 31008 | |
| Hospital Universitario de Canarias | |
| La Laguna, Tenerife, Spain, 38320 | |
| Complejo Hospitalario Universitario A Coruña | |
| A Coruña, Spain, 15006 | |
| Hospital Clinic i Provincial | |
| Barcelona, Spain, 08036 | |
| Hospital del Mar | |
| Barcelona, Spain, 08003 | |
| Hospital Vall d´Hebron | |
| Barcelona, Spain, 08035 | |
| Hospital de Basurto | |
| Bilbao, Spain, 48013 | |
| Hospital San Pedro Alcántara | |
| Cáceres, Spain, 10002 | |
| Hospital Puerta del Mar | |
| Cádiz, Spain, 11009 | |
| Hospital de Jaén | |
| Jaén, Spain, 23007 | |
| Hospital Ramón y Cajal | |
| Madrid, Spain, 28034 | |
| Hospital La Paz | |
| Madrid, Spain, 28046 | |
| Hospital 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital Gregorio Marañón | |
| Madrid, Spain, 28009 | |
| Hospital Morales Meseguer | |
| Murcia, Spain, 30008 | |
| Complejo Hospitalario Carlos Haya | |
| Málaga, Spain, 29010 | |
| Hospital de Salamanca | |
| Salamanca, Spain, 37007 | |
| Hospital General de Segovia | |
| Segovia, Spain, 42002 | |
| Hospital Virgen del Rocío | |
| Sevilla, Spain, 41013 | |
| Hospital Clínico Universitario de Valencia | |
| Valencia, Spain, 46010 | |
| Hospital Universitario Dr. Peset | |
| Valencia, Spain, 46017 | |
| Hospital General de Valencia | |
| Valencia, Spain, 46014 | |
| Hospital Arnau de Vilanova | |
| Valencia, Spain, 46015 | |
| Hospital Río Hortega | |
| Valladolid, Spain, 47012 | |
| Hospital Virgen de la Concha | |
| Zamora, Spain, 49022 | |
| Hospital Miguel Servet | |
| Zaragoza, Spain, 50009 | |
| Hospital Clínico de Zaragoza | |
| Zaragoza, Spain, 50009 | |
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Investigators
| Principal Investigator: | Francisco Javier Peñalver Párraga, MD | Hospital Fundación de Alcorcon |
| Principal Investigator: | Javier De la Serna Torroba, MD | Hospital 12 de Octubre |
| Principal Investigator: | Jose Antonio García Vela, MD | Hospital de Getafe |
| Principal Investigator: | Patricia Font López, MD | Hospital Gregorio Marañón |
| Principal Investigator: | Secundino Ferrer Bordas, MD | Hospital Dr. Peset |
| Principal Investigator: | Encarnación Monzó Castellano, MD | Hospital Arnau de Vilanova |
| Principal Investigator: | Eulogio Conde García, MD | Hospital Marqués de Valdecilla |
| Principal Investigator: | José Antonio Márquez Navarro, MD | Hospital de Basurto |
| Principal Investigator: | Ernesto Pérez Persona, MD | Hospital Txagorritxu |
| Principal Investigator: | Garazi Letamendi Madariaga, MD | Hospital de Galdakao |
| Principal Investigator: | Pilar Giraldo Castellanos, MD | Hospital Miguel Servet |
| Principal Investigator: | Luis Palomera, MD | Hospital Clínico de Zaragoza |
| Principal Investigator: | Andrés López Hernández, MD | Hospital Vall d´Hebron |
| Principal Investigator: | Blanca Sánchez, MD | Hospital del Mar |
| Principal Investigator: | José Luis Sánchez-Majado, MD | Hospital San Juan de Alicante |
| Principal Investigator: | Antonio Gutiérrez García, MD | Hospital Son Espases |
| Principal Investigator: | Francisco Javier Capote Huelva, MD | Hospital Puerta del Mar |
| Principal Investigator: | Ana Marín Niebla, MD | Hospital Virgen del Rocío |
| Principal Investigator: | Mª José Ramírez, MD | Hospital de Jerez |
| Principal Investigator: | Fernando Carnicero González, MD | Hospital San Pedro de Alcántara |
| Principal Investigator: | Mª José Rodríguez Salazar, MD | Hospital Universitario de Canarias |
| Principal Investigator: | Miguel Ángel Canales Albendea, MD | Hospital La Paz |
| Principal Investigator: | José Antonio García Marco, MD | Hospital Puerta de Hierro |
| Principal Investigator: | Carlos Montalbán Sanz, MD | Hospital Ramón y Cajal |
| Principal Investigator: | Rosalía Riaza Grau, MD | Hospital Severo Ochoa |
| Principal Investigator: | Mª Dolores Caballero Barrigón, MD | Hospital de Salamanca |
| Principal Investigator: | Mª Jesús Peñarrubia Ponce, MD | Hospital Río Hortega |
| Principal Investigator: | José Antonio Queizán, MD | Hospital de Segovia |
| Principal Investigator: | Roberto Hernández Martín, MD | Hospital Virgen de la Concha |
| Principal Investigator: | Mª José Terol Castera, MD | Hospital Clínico de Valencia |
| Principal Investigator: | Félix Carbonell, MD | Hospital General de Valencia |
| Principal Investigator: | Rosario Varela Gómez, MD | Complejo Hospitalario A Coruña |
| Principal Investigator: | José Luis Bello López, MD | C. H. U. Santiago |
| Principal Investigator: | Carlos Panizo, MD | Clínica Universitaria de Navarra |
| Principal Investigator: | Juan Manuel Sancho CIa, MD | HOSPITAL GERMANS TRIAS I PUJOL |
| Principal Investigator: | Armando López Guillermo, MD | Hospital Clínic i Provincial |
| Principal Investigator: | Elena Pérez Ceballos, MD | Hospital Morales Meseguer |
| Principal Investigator: | Andrés Sánchez Salinas, MD | Hospital Universitario Virgen de la Arrixaca |
| Principal Investigator: | Mª Soledad Durán Nieto, MD | Hospital de Jaén |
| Principal Investigator: | Manuel Espeso de Haro, MD | Hospital Carlos Haya |
| Principal Investigator: | Joan Bargay Lleonart, MD | Hospital Son Llàtzer |
More Information
No publications provided
| Responsible Party: | Francisco Javier Peñalver/MD, GELTAMO |
| ClinicalTrials.gov Identifier: | NCT01133158 History of Changes |
| Other Study ID Numbers: | R-BMD GELTAMO 08 |
| Study First Received: | February 11, 2010 |
| Last Updated: | October 30, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines Spain: Ethics Committee |
Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
|
Follicular non-Hodgkin's lymphoma in relapse or refractory to standard first-line immunochemotherapy |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Bendamustine Rituximab Mitoxantrone BB 1101 |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013