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R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01133158
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: R-BMD
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years
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
Other Name: R-BMD

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 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 :
  1. Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response. [ Time Frame: 7 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133158

Show Show 41 study locations
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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Principal Investigator: Francisco Javier Peñalver Párraga, MD Hospital Universitario Fundación Alcorcón
Principal Investigator: Javier De la Serna Torroba, MD Hospital 12 de Octubre
Principal Investigator: Francisca Oña Compan, MD Hospital de Getafe.
Principal Investigator: Patricia Font López, MD Gregorio Marañón Hospital
Principal Investigator: Secundino Ferrer Bordas, MD Hospital Dr. Peset
Principal Investigator: José Ramón Mayans Ferrer, 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 Bernal, MD Hospital Clínico de Zaragoza
Principal Investigator: Andrés López Hernández, MD Hospital Vall d´Hebron
Principal Investigator: Blanca Sánchez González, 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 Universitario Puerta del Mar
Principal Investigator: Fátima de la Cruz, MD Hospital Virgen del Rocío
Principal Investigator: Mª José Ramírez, MD Hospital de Jerez
Principal Investigator: Fernando Carnicero González, MD Hospital San Pedro de Alcantara
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 Universitario de Valencia
Principal Investigator: María 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 Germans Trias i Pujol Hospital
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier: NCT01133158    
Other Study ID Numbers: R-BMD GELTAMO 08
First Posted: May 28, 2010    Key Record Dates
Results First Posted: November 1, 2018
Last Update Posted: November 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
Follicular non-Hodgkin's lymphoma relapse refractory
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action