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

Primary Purpose

MALT LYMPHOMA

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Rituximab and Bendamustine

About this trial

This is an interventional treatment trial for MALT LYMPHOMA focused on measuring CD 20 positive

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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)
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

Exclusion Criteria:

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab and Bendamustine

Arm Description

Outcomes

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 Criteria for evaluation of response in NHL

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

Full Information

NCT ID

NCT01015248

First Posted

November 17, 2009

Last Updated

September 6, 2016

Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

1. Study Identification

Unique Protocol Identification Number

NCT01015248

Brief Title

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

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

MALT LYMPHOMA

Keywords

CD 20 positive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rituximab and Bendamustine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Rituximab and Bendamustine

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

2 years follow-up

Secondary Outcome Measure Information:

Title

Time Frame

2 years follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials: