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Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

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. Identifier: NCT01015248
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : September 7, 2016
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Brief Summary:

The aim of the study is to assess the therapeutic activity and safety of the combination of Bendamustine and Rituximab in MALT lymphomas.

Primary endpoint:

  • Event-free-survival (EFS) (failure or death from any cause) for all patients.

Secondary endpoints:

  • Complete and partial remission rates for all patients
  • Response duration (time to relapse or progression) for responder patients
  • Progression-free-survival (PFS) (disease progression or death from lymphoma: for all patients
  • Overall survival for all patients
  • Acute and long-term toxicity

Condition or disease Intervention/treatment Phase
MALT LYMPHOMA Drug: Rituximab and Bendamustine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric, Non-Randomized Phase 2 Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma
Study Start Date : May 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Rituximab and Bendamustine Drug: Rituximab and Bendamustine
Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2

Primary Outcome Measures :
  1. The primary endpoint of assessment is the event-free-survival (EFS) according to the criteria of the International Workshop to Standardize Response Criteria for NHL and Criteria for evaluation of response in NHL [ Time Frame: 2 years follow-up ]

Secondary Outcome Measures :
  1. Include evaluation of the next parameters: Complete and partial remission rates for all patients Response duration for responder patients PFS for all patients Overall survival for all patients Acute and long-term toxicity [ Time Frame: 2 years follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site (WHO classification)
  2. Any stage (Ann Arbor I-IV)
  3. The novo disease en any extranodal site. For primary gastric or cutaneous lymphoma, local/specific previous treatment is accepted, just following the below criteria:

    1. Cutaneous lymphoma: recurrent lymphoma after local therapy
    2. Gastric lymphoma:

    b1. H. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics).

    b2. H. pylori-positive cases at diagnosis, who failed antibiotic therapy, including patients with: clinical (endoscopic) and histological evidence of disease progression at any time post H. pylori eradication; stable disease with persistent lymphoma at 1 year post H. pylori eradication; relapse (without H. pylori re-infection), after a remission; patients who failed either first line antibiotics or further local treatment (surgery or radiotherapy)

  4. No evidence of histologic transformation to a high grade lymphoma
  5. Measurable or evaluable disease
  6. Age >18 and <85
  7. ECOG performance status 0-2
  8. Life expectancy of at least 1 year
  9. Written informed consent given according to national/local regulations

Exclusion Criteria:

  1. Prior chemotherapy or prior immunotherapy with any anti-CD20 monoclonal antibody
  2. Prior radiotherapy in the last 6 weeks
  3. Corticosteroids during the last 28 days, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
  4. Major impairment of renal function (serum creatinine > 2,5 x upper normal) or liver function (ASAT/ALAT <2,5 x upper normal, total bilirubin <2,5x upper normal), unless due to lymphoma involvement.
  5. Impairment of bone marrow function (WBC <3.0x109/L, ANC <1.5x109/L, PLT <100x109/L), unless due to lymphoma involvement
  6. Evidence of clinically significant cardiac, neurological or metabolic disease, unless due to lymphoma involvement
  7. Evidence of symptomatic central nervous system (CNS) disease
  8. Active HBV and/or HCV infection
  9. Known HIV infection
  10. Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
  11. Any psychiatric disease potentially hampering compliance with the study protocol and follow-up schedule
  12. Potential to attend regular visits to the hospital, on an outpatient regimen
  13. Hypersensibility to any compound of the study medication.
  14. Non appropriate contraceptive method in women of childbearing potential or men
  15. Treatment with any drug under research within 30 days previous to start the study medication.

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 identifier (NCT number): NCT01015248

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Hospital Central de Asturias
Oviedo, Asturias, Spain, 33006
ICO-Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08918
ICO-Hospital Durans i Reynals
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain, 15706
Hospital Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
Hospital Son Llátzer
Palma de Mallorca, Mallorca, Spain, 07198
Clínica Universitaria Navarra
Pamplona, Navarra, Spain, 31008
Hospital Universitario de Canarias
Sta. Cruz de Tenerife, Tenerife, Spain, 38320
Hospital del Mar
Barcelona, Spain, 08003
Hospital La Princesa
Madrid, Spain, 28006
Hospital MD Anderson
Madrid, Spain, 28033
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital La Paz
Madrid, Spain, 28046
Hospital Morales Meseguer
Murcia, Spain, 30008
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Clínico de Zaragoza "Lozano Blesa"
Zaragoza, Spain, 50009
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
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Principal Investigator: Carlos Montalbán, MD Ramon y Cajal Hospital
Principal Investigator: Antonio Salar, MD Hospital del Mar
Principal Investigator: Ana Muntañola, MD Mutua de Terrassa Hospital
Principal Investigator: Mª José Rodríguez, MD Hospital Universitario de Canarias
Principal Investigator: María José Terol, MD Hospital Clínico de Valencia
Principal Investigator: Juan Manuel Sancho, MD ICO Hospital Germans Trias i Pujol
Principal Investigator: Eva Domingo, MD ICO Hospital Durans i Reynals
Principal Investigator: Grande Carlos, MD 12 de Octubre Hospital
Principal Investigator: Carlos Panizo, MD Clínica Universitaria Navarra
Principal Investigator: Miguel Canales, MD La Paz Hospital
Principal Investigator: Raquel Oña, MD MD Anderson Hospital
Principal Investigator: Reyes Arranz, MD La Princesa Hospital
Principal Investigator: Dolores Caballero, MD Hospital Unisversitario de Salamanca
Principal Investigator: José Luis Bello, MD Complejo Hospitalario Universitario de Santiago
Principal Investigator: Joan Bargay, MD Son Llátzer Hospital
Principal Investigator: Luis Palomera, MD Hospital Clínico de Zaragoza
Principal Investigator: Franciaco Javier Peñalver, MD Fundación Hospital Alcorcón
Principal Investigator: Eulogio Conde, MD Marqués de Valdecilla Hospital
Principal Investigator: José Javier Sánchez-Blanco, MD Morales Meseguer Hospital
Principal Investigator: Concepción Nicolás, MD Central de Asturias Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea Identifier: NCT01015248     History of Changes
Other Study ID Numbers: MALT2008-01
No EudraCT: 2008-007725-39
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
CD 20 positive

Additional relevant MeSH terms:
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Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action