Patients with MALT Lymphoma treated with chlorambucil and rituximab followed by maintenance treatment with subcutaneous rituximab MedDRA version: 16.1 Level: LLT Classification code 10060707 Term: MALT lymphoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Rituximab SC
Product Code: RO 45-2294
Pharmaceutical Form: Solution for injection/infusion
Trade Name: Mabthera 500 mg
Product Name: MabThera IV (rituximab) 500 mg
Product Code: RO 45-2
Sponsors
IELSG (International Extranodal Lymphoma Study Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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: a. H. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics). b. 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) 1.2 Similar consideration may be applied to patients with ocular adnexal lymphoma treated with antibiotics. 2. 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. 3. Any stage (Ann Arbor I-IV) 4. Age = 18 5. Life expectancy of at least 1 year 6. ECOG performance status 0-2 7. Adequate bone marrow function (WBC >3.0x109/L, ANC >1.5x109/L, PLT >100x109/L), unless due to lymphoma involvement 8. Adequate kidney (serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age rang
Exclusion criteria
Exclusion criteria: 1. Evidence of histologic transformation to a high grade lymphoma 2. Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer 3. Prior chemotherapy 4. Prior immunotherapy with any anti-CD20 monoclonal antibody 5. Prior radiotherapy in the last 6 weeks 6. 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 7. Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhytmias, congestive heart failure or myocardial infarction within 12 months before study entry 8. Evidence of symptomatic central nervous system (CNS) disease 9. Evidence of active opportunistic infections 10. Known HIV infection 11. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded 12. Positive serology for hepatitis C (HC) defined as a positive test for HCAb, confirmed by HC RIBA immunoblot assay on the same sample. 13. Pregnant or lactating status 14. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 15. Fertile men or women of childbearing potential who do not agree to use a highly effective measure of contraception (such as oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) throughout the study and for at least 12 months after the last dose of subcutaneous rituximab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of the study is to assess the therapeutic safety and activity of the combination of Chlorambucil and Rituximab given for 6 months, followed by 2 years maintenance treatment with subcutaneous Rituximab alone in MALT lymphomas.;Secondary Objective: Efficacy and safety of study treatment;Primary end point(s): Complete Remission rate at 6 months;Timepoint(s) of evaluation of this end point: Completion of induction phase II (6 months from study entry) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response rate (Complete and partial remission rates) for all patients; Progression-free-survival (PFS) (any case) Event-free-survival (EFS) at 5 years for all patients; Overall survival for all patients; Response duration for responder patients; Acute and long-term toxicity;Timepoint(s) of evaluation of this end point: End of induction phase I, induction phase II, maintenance phase, end of follow up | — |
Countries
France, Italy, Switzerland
Contacts
Public ContactIELSG Operation office
IELSG
Outcome results
None listed