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

MALT LYMPHOMA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015248
• Other study ID #: MALT2008-01
• Secondary ID: No EudraCT: 2008
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2009
• Last updated: September 6, 2016
• Start date: May 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2016
• Source: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• MALT LYMPHOMA

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Fundación Alcorcón	Alcorcón	Madrid
Spain	ICO-Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	ICO-Hospital Durans i Reynals	Hospitalet de Llobregat	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital MD Anderson	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Morales Meseguer	Murcia
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Hospital Son Llátzer	Palma de Mallorca	Mallorca
Spain	Clínica Universitaria Navarra	Pamplona	Navarra
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Marqués de Valdecilla	Santander	Cantabria
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	La Coruña
Spain	Hospital Universitario de Canarias	Sta. Cruz de Tenerife	Tenerife
Spain	Hospital Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital Clínico de Zaragoza "Lozano Blesa"	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes