Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: clarithromycin, oral, high dose

• Registration Number: NCT01516606
• Lead Sponsor: Andres J. M. Ferreri

Brief Summary

This is a prospective, phase II study on the activity and tolerability of high dose (2 g/day) oral clarithromycin for the treatment of relapsed or refractory extranodal marginal zone lymphoma.

Detailed Description

A 6-month regimen of oral clarithromycin has been associated with a 35% ORR in patients with relapsed/refractory marginal zone B-cell lymphoma. Responses were more common among patients with conjunctival lymphoma. This could be explained at least in part by the elimination of clarithromycin by tears, suggesting that a higher tumor bioavailability of this antibiotic could result in a higher activity. Thus, a higher dose of clarithromycin could be associated with a higher tumor bioavailability in tissues other than the conjunctiva.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-25
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• histologically confirmed diagnosis of extranodal extra-gastric marginal zone cell B lymphoma or gastric Helicobacter pylori positive lymphoma refractory to conventional antibiotic therapy, or H. pylori negative
• at least one measurable lesion
• relapsed or refractory lymphoma after systemic (chemotherapy, immunotherapy, antibiotic) or local (surgery or radiation) therapy
• ECOG PS </= 3
• no prior antibiotic therapy within 3 months before enrollment

Exclusion Criteria

• HIV 1-2 infection
• concomitant conventional or experimental antitumor therapy (chemotherapy, radiotherapy, immunotherapy, corticosteroids)
• severe inadequate liver (AST </=3 ULN, ALT </= 3 ULN, bilirubin </=3 ULN) or renal (creatinine </= 1.5 ULN) function
• allergy to macrolides
• concomitant malignant neoplasms within prior 5 years (with the exclusion of basal cell carcinoma, in situ spinocellular carcinoma of skin and cervix)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
clarithromycin, oral, high dose	clarithromycin, oral, high dose	2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total

Primary Outcome Measures

Name	Time	Method
assessment of responses	The best clinical response at 6 months from trial registration	evaluation of activity in terms of global responses, complete responses and duration of responses

Trial Locations

Locations (1)

Dpt of OncoHematology - Fondazione Centro San Raffaele del Monte Tabor; 🇮🇹 Milan, Italy