Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma (NCT01808599) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma
France112 participantsStarted 2013-12
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma) arisen at any extranodal site 1.1 The following patients with gastric MALT Lymphoma can be entered:
✓. Measurable or evaluable disease. Measurable disease in at least two perpendicular dimensions on an imaging scan is defined as: lymph node or nodal mass bi-dimensional measurement with \> 1.5 cm in longest transverse diameter or the short diameter must measure \> 10 mm regardless of the longest transverse diameter.
✓. Any stage (Ann Arbor I-IV) (see Appendix A)
✓. Age ≥ 18
✓. Life expectancy of at least 1 year
✓. ECOG performance status 0-2 (see Appendix B)
✓. Adequate bone marrow function (WBC \>3.0x109/L, ANC \>1.5x109/L, PLT \>100x109/L), unless due to lymphoma involvement
✓. Adequate kidney (serum creatinine \<1,5x upper normal) and liver function (ASAT/ALAT \<2,5 upper normal, total bilirubin \<2,5x upper normal), unless due to lymphoma involvement
Exclusion criteria
✕. Evidence of histologic transformation to a high grade lymphoma
✕. Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
What they're measuring
1
Complete remission rate
Timeframe: week 25
Trial details
NCT IDNCT01808599
SponsorInternational Extranodal Lymphoma Study Group (IELSG)
✕. Prior immunotherapy with any anti-CD20 monoclonal antibody
✕. Prior radiotherapy in the last 6 weeks
✕. Use of 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
✕. Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry
✕. Evidence of symptomatic central nervous system (CNS) disease