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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT01015248
First received: November 17, 2009
Last updated: May 26, 2014
Last verified: June 2011
  Purpose

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 Intervention Phase
MALT LYMPHOMA
Drug: Rituximab and Bendamustine
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: Multicentric, Non-Randomized Phase 2 Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

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 of assessment is the event-free-survival (EFS) according to the criteria of the International Workshop to Standardize Response Criteria for NHL and Criteriafor evaluation of response in NHL [ Time Frame: 2 years follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: May 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab and Bendamustine Drug: Rituximab and Bendamustine
Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01015248

Locations
Spain
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 Ramón y Cajal
Madrid, Spain, 28034
Hospital La Princesa
Madrid, Spain, 28006
Hospital La Paz
Madrid, Spain, 28046
Hospital MD Anderson
Madrid, Spain, 28033
Hospital 12 de Octubre
Madrid, Spain, 28041
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
Investigators
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
  More Information

No publications provided

Responsible Party: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier: NCT01015248     History of Changes
Other Study ID Numbers: MALT2008-01, No EudraCT: 2008-007725-39
Study First Received: November 17, 2009
Last Updated: May 26, 2014
Health Authority: Spain: Ethics Committee
Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on August 28, 2014