R-BMD GELTAMO Relapsed Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT01133158
First received: February 11, 2010
Last updated: August 22, 2013
Last verified: August 2013
  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:


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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Universitario Ramon 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: August 22, 2013
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 July 20, 2014