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

NCT01015248 | Completed Phase 2

• 2 other identifiers: MALT2008-01No EudraCT: 2008-007725-39
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 19

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

Conditions

MALT LYMPHOMA

Keywords

CD 20 positive

Outcome Measures

Primary Outcomes (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

  2 years follow-up

Secondary Outcomes (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

  2 years follow-up

Study Arms (1)

Rituximab and Bendamustine

EXPERIMENTAL

Drug: Rituximab and Bendamustine

Interventions

Rituximab and Bendamustine DRUG

Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2

Rituximab and Bendamustine

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site (WHO classification)
• Any stage (Ann Arbor I-IV)
• The novo disease en any extranodal site. For primary gastric or cutaneous lymphoma, local/specific previous treatment is accepted, just following the below criteria:
• Cutaneous lymphoma: recurrent lymphoma after local therapy
• 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)
• No evidence of histologic transformation to a high grade lymphoma
• Measurable or evaluable disease
• Age \>18 and \<85
• ECOG performance status 0-2
• Life expectancy of at least 1 year
• Written informed consent given according to national/local regulations

You may not qualify if:

• Prior chemotherapy or prior immunotherapy with any anti-CD20 monoclonal antibody
• Prior radiotherapy in the last 6 weeks
• 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
• 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.
• Impairment of bone marrow function (WBC \<3.0x109/L, ANC \<1.5x109/L, PLT \<100x109/L), unless due to lymphoma involvement
• Evidence of clinically significant cardiac, neurological or metabolic disease, unless due to lymphoma involvement
• Evidence of symptomatic central nervous system (CNS) disease
• Active HBV and/or HCV infection
• Known HIV infection
• Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
• Any psychiatric disease potentially hampering compliance with the study protocol and follow-up schedule
• Potential to attend regular visits to the hospital, on an outpatient regimen
• Hypersensibility to any compound of the study medication.
• Non appropriate contraceptive method in women of childbearing potential or men
• Treatment with any drug under research within 30 days previous to start the study medication.

Sponsors & Collaborators

• Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea: lead

Study Sites (19)

ICO-Hospital Germans Trias i Pujol

Badalona, Barcelona, 08918, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

ICO-Hospital Durans i Reynals

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital La Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital MD Anderson

Madrid, Madrid, 28033, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Son Llátzer

Palma de Mallorca, Mallorca, 07198, Spain

Location

Hospital Morales Meseguer

Murcia, Murcia, 30008, Spain

Location

Clínica Universitaria Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, 38320, Spain

Location

Hospital Clínico de Zaragoza "Lozano Blesa"

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (1)

• Salar A, Domingo-Domenech E, Panizo C, Nicolas C, Bargay J, Muntanola A, Canales M, Bello JL, Sancho JM, Tomas JF, Rodriguez MJ, Penalver FJ, Grande C, Sanchez-Blanco JJ, Palomera L, Arranz R, Conde E, Garcia M, Garcia JF, Caballero D, Montalban C; Grupo Espanol de Linfomas/Trasplante de Medula Osea (GELTAMO). First-line response-adapted treatment with the combination of bendamustine and rituximab in patients with mucosa-associated lymphoid tissue lymphoma (MALT2008-01): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2014 Dec;1(3):e104-11. doi: 10.1016/S2352-3026(14)00021-0. Epub 2014 Nov 19.

  PMID: 27029228 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Rituximab; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 18, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

ES (19)