Clinical trial NCT01015248: Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: MALT LYMPHOMA
Keywords: CD 20 positive
Lead sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: 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
timeFrame: 2 years follow-up
Secondary outcomes:
measure: 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
timeFrame: 2 years follow-up
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: ICO-Hospital Germans Trias i Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: ICO-Hospital Durans i Reynals
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
state: Cantabria
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: La Coruña
city: Alcorcón
country: Spain
facility: Hospital Fundación Alcorcón
state: Madrid
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llátzer
state: Mallorca
city: Pamplona
country: Spain
facility: Clínica Universitaria Navarra
state: Navarra
city: Sta. Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital MD Anderson
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Zaragoza
country: Spain
facility: Hospital Clínico de Zaragoza "Lozano Blesa"
Study officials:
affiliation: Ramon y Cajal Hospital
name: Carlos Montalbán, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: Antonio Salar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mutua de Terrassa Hospital
name: Ana Muntañola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Canarias
name: Mª José Rodríguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico de Valencia
name: María José Terol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICO Hospital Germans Trias i Pujol
name: Juan Manuel Sancho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICO Hospital Durans i Reynals
name: Eva Domingo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 12 de Octubre Hospital
name: Grande Carlos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Universitaria Navarra
name: Carlos Panizo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Paz Hospital
name: Miguel Canales, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MD Anderson Hospital
name: Raquel Oña, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Princesa Hospital
name: Reyes Arranz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Unisversitario de Salamanca
name: Dolores Caballero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario Universitario de Santiago
name: José Luis Bello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Son Llátzer Hospital
name: Joan Bargay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico de Zaragoza
name: Luis Palomera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación Hospital Alcorcón
name: Franciaco Javier Peñalver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marqués de Valdecilla Hospital
name: Eulogio Conde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Morales Meseguer Hospital
name: José Javier Sánchez-Blanco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central de Asturias Hospital
name: Concepción Nicolás, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.