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

NCT ID: NCT01015248

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab and Bendamustine

Group Type: EXPERIMENTAL

Rituximab and Bendamustine

Intervention Type: DRUG

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

Interventions

Rituximab and Bendamustine

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Muntañola, MD

Role: PRINCIPAL_INVESTIGATOR

Mutua de Terrassa Hospital

Mª José Rodríguez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Canarias

María José Terol, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico de Valencia

Juan Manuel Sancho, MD

Role: PRINCIPAL_INVESTIGATOR

ICO Hospital Germans Trias i Pujol

Eva Domingo, MD

Role: PRINCIPAL_INVESTIGATOR

ICO Hospital Durans i Reynals

Grande Carlos, MD

Role: PRINCIPAL_INVESTIGATOR

12 de Octubre Hospital

Carlos Panizo, MD

Role: PRINCIPAL_INVESTIGATOR

Clínica Universitaria Navarra

Miguel Canales, MD

Role: PRINCIPAL_INVESTIGATOR

La Paz Hospital

Carlos Montalbán, MD

Role: PRINCIPAL_INVESTIGATOR

Ramon y Cajal Hospital

Antonio Salar, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Raquel Oña, MD

Role: PRINCIPAL_INVESTIGATOR

MD Anderson Hospital

Reyes Arranz, MD

Role: PRINCIPAL_INVESTIGATOR

La Princesa Hospital

Dolores Caballero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Unisversitario de Salamanca

José Luis Bello, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario de Santiago

Joan Bargay, MD

Role: PRINCIPAL_INVESTIGATOR

Son Llátzer Hospital

Luis Palomera, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico de Zaragoza

Franciaco Javier Peñalver, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación Hospital Alcorcón

Eulogio Conde, MD

Role: PRINCIPAL_INVESTIGATOR

Marqués de Valdecilla Hospital

José Javier Sánchez-Blanco, MD

Role: PRINCIPAL_INVESTIGATOR

Morales Meseguer Hospital

Concepción Nicolás, MD

Role: PRINCIPAL_INVESTIGATOR

Central de Asturias Hospital

Locations

ICO-Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital del Mar

Barcelona, Barcelona, Spain

ICO-Hospital Durans i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Mutua de Terrassa

Terrassa, Barcelona, Spain

Hospital Marqués de Valdecilla

Santander, Cantabria, Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

Hospital Fundación Alcorcón

Alcorcón, Madrid, Spain

Hospital La Princesa

Madrid, Madrid, Spain

Hospital MD Anderson

Madrid, Madrid, Spain

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Hospital 12 de Octubre

Madrid, Madrid, Spain

Hospital La Paz

Madrid, Madrid, Spain

Hospital Son Llátzer

Palma de Mallorca, Mallorca, Spain

Hospital Morales Meseguer

Murcia, Murcia, Spain

Clínica Universitaria Navarra

Pamplona, Navarre, Spain

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitario de Salamanca

Salamanca, Salamanca, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, Spain

Hospital Clínico de Zaragoza "Lozano Blesa"

Zaragoza, Zaragoza, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 27029228 (View on PubMed)

Other Identifiers

No EudraCT: 2008-007725-39

Identifier Type: -

Identifier Source: secondary_id

MALT2008-01

Identifier Type: -

Identifier Source: org_study_id