patients with extranodal marginal zone relapsed or refractory lymphoma MedDRA version: 14.1 Level: PT Classification code 10015823 Term: Extranodal marginal zone B-cell lymphoma (MALT type) recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10015824 Term: Extranodal marginal zone B-cell lymphoma (MALT type) refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspec
Conditions
Interventions
Trade Name: KLACID*14CPR RIV 500MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: claritromicina
CAS Number: 81103-11-9
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histological diagnosis of B-cell lymphoma of extranodal marginal zone extragastric or gastric Helicobacter pylori-positive refractory to conventional antibiotic therapy or H. pylori negative -least one measurable/ configurable lesion -lymphoma relapsed or refractory to systemic therapies (chemotherapy, immunotherapy, antibiotic therapy) or local (surgery or radiotherapy)-age > or equal 18 years -ECOG-PS =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: -HIV 1-2 infections -conventional cancer treatments (chemotherapy, radiotherapy, immunotherapy, corticosteroids) or experimental concomitant severe hepatic impairment (AST < = 3 UNL, ALT < = 3 UNL, bilirubin < = 3 UNL) and renal (creatinine = 1 , 5 UNL) that is not due to lymphoma -allergy to macrolides -ongoing pregnancy and nursing -presence of other malignancies in the past 5 years (except basal cell skin squamous cell carcinomas in situ of the skin or cervical)-presence of any physical or mental condition that prevents the intake of antibiotic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the activity of oral clarithromycin high-dose (2 g/day) in patients with extranodal marginal zone relapsed / refractory lymphoma.;Secondary Objective: to assess the feasibility and tolerability of oral clarithromycin at high doses (2 g / day) in the treatment of extranodal marginal zone relapsed / refractory lymphoma.;Primary end point(s): activity of clarithromycin oral high-dose (2 g / day) in terms of overall response, complete response and duration of response. Based on previous clinical experience of the one part of the marginal zone lymphomas, we expect a higher overall response rate of 38%. Responses will be evaluated during treatment and for the duration of follow-up.;Timepoint(s) of evaluation of this end point: during treatment and at follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): security of oral clarithromycin at high doses , defined as adverse events of grade > or = 3 (NCI CTCAE v. 4.3) in patients enrolled in the protocol. The AE will be recorded during treatment and follow-up, until the end of the study. -Overall survival (OS), as months of survival from participation in the experimental protocol until death from any cause. The OS data will be collected for all patients enrolled even after exit from the study.;Timepoint(s) of evaluation of this end point: during treatment and at follow up | — |
Countries
Italy
Contacts
Public ContactUnita' Operativa Linfomi
Fondazione San Raffaele del Monte Tabor
Outcome results
None listed