Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Asso… (NCT01015248) | Clinical Trial Compass
CompletedPhase 2
Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma
Spain60 participantsStarted 2009-05
Plain-language 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
Who can participate
Age range18 Years – 84 Years
SexALL
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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:
✓. No evidence of histologic transformation to a high grade lymphoma
✓. Measurable or evaluable disease
✓. Age \>18 and \<85
Exclusion criteria
✕. Prior chemotherapy or prior immunotherapy with any anti-CD20 monoclonal antibody
✕. Prior radiotherapy in the last 6 weeks
What they're measuring
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
✕. 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