drugset / Trial / NCT01808599

Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma

NCT01808599

Phase 2 Active not recruiting 112 enrolled International Extranodal Lymphoma Study Group (IELSG)
NaSingle-groupOpen-labelTreatment

Summary

Single arm phase II study of Chlorambucil in combination with subcutaneous Rituximab followed by maintenance therapy with subcutaneous Rituximab in patients with histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site, either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma).

Timeline

Start
2013-12
Primary completion
2016-03
Completion
2028-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorambucil Other / unclassified 6 mg/m2 Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 1400 mg Subcutaneous

Indications