90Y ibritumomab tiuxetan (Zevalin®) in patients with extra-nodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT Lymphoma) - ZENO
- Conditions
- extra-nodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT Lymphoma)MedDRA version: 9.1Level: LLTClassification code 10060707Term: MALT lymphoma
- Registration Number
- EUCTR2007-004289-42-GR
- Lead Sponsor
- ational and Kapodistrian University of Athens
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
•Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extra nodal site
•Any stage (Ann Arbor I-IV)
•Either de novo, or relapsed/refractory disease following local therapy (including surgery, radiotherapy, and antibiotics for Helicobacter pylori-positive gastric lymphoma) or prior chemotherapy regimen +/- anti-CD20 immunotherapy
•No evidence of histologic transformation to a high grade lymphoma
•Measurable or evaluable disease
•For primary gastric localized Helicobacter pylori-positive disease at diagnosis: 1) persistent disease 1 year after documented Helicobacter pylori infection eradication and 2) clinical, endoscopic (or histologic) evidence of progression at any time after Helicobacter pylori infection eradication
•Patient age > 18 years
•performance status ECOG <2
•life expectancy of at least 6 months
•effective contraception in female pre-menopausal patients
•No prior disease of neoplasm within 5 years, except cervical intra-epithelial neoplasia type-1(CIN1) or localized non melanomatous skin cancer
•No prior chemotherapy, immunotherapy and radiotherapy in the last 6 weeks
•No 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
•No 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
•No evidence of symptomatic central nervous system (CNS) disease
•No impairment of bone marrow function (WBC >3,000/mm3, ANC >1,500/mm3, PLT >100,000/mm3)
•No impairment of renal or liver function, unless due to lymphoma involvement
•No known HIV infection, no active HBV and/or HCV infection and no evidence of active opportunistic infection
•No pregnant or lactating status and appropriate contraceptive method in women of childbearing potential
•Appropriate contraceptive method in men
•No psychiatric illness precluding understanding concepts of the trial or signing informed consent
•The patient has given written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Prior autologous or allogeneic SCT or previous organ transplantation
•>25% bone marrow infiltration
•active auto-immune haemolytic anaemia
•participation in another clinical trial during the last 4 weeks
•renal insufficiency (creatinine > 2.0 mg/dl), not related to lymphoma
•hepatic insufficiency (transaminase >3-fold of upper normal limit or
bilirubin > 2.0 mg/dl), not related to lymphoma
•active infection (e.g. HBV, HCV, HIV)
•concurrent disease which may hamper the per protocol therapy
•severe psychiatric disease or cerebral dysfunction
•women during lactation or pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Antitumor activity, in terms of overall response rate (ORR);Secondary Objective: Safety, as acute and long-term toxicity; Response duration (RD) in responders; progression-free survival (PFS) in all patients; Histological response and molecular residual disease (MRD) for gastric MALT lymphoma.;Primary end point(s): The overall response rate (overall response rate - ORR) at 3 months after Zevalin administration
- Secondary Outcome Measures
Name Time Method