ZENO-01 90Y ibritumomab tiuxetan in patients with extra-nodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT Lymphoma)

• Conditions: MALT Lymphoma; MedDRA version: 14.1Level: LLTClassification code 10060707Term: MALT lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001768-31-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-02
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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 • ECOG performance status = 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

• 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

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; Progression-free survival (PFS); Histological response and molecular residual disease (MRD) for gastric MALT lymphoma;Primary end point(s): Antitumor activity, in terms of overall response rate (ORR);Timepoint(s) of evaluation of this end point: 3 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety, as acute and long-term toxicity; Progression-free survival (PFS); Histological response and molecular residual disease (MRD) for gastric MALT lymphoma;Timepoint(s) of evaluation of this end point: 3 years