extra-nodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT Lymphoma) MedDRA version: 9.1 Level: LLT Classification code 10060707 Term: MALT lymphoma
Conditions
Interventions
Trade Name: Zevalin
Product Name: Zevalin
Product Code: not applicable
Pharmaceutical Form: Kit for radiopharmaceutical preparation
INN or Proposed INN: ibritumomab tiuxetan
CAS Number: 174722-31-7
Co
Sponsors
National and Kapodistrian University of Athens
Eligibility
Sex/Gender
All
Inclusion criteria
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 • performance status ECOG 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
Exclusion criteria
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 • women during lactation or pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Greece
Outcome results
None listed