Status:
COMPLETED
Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma
Lead Sponsor:
Andres J. M. Ferreri
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 conjuncti...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01516606
Start Date
January 1 2012
End Date
December 1 2014
Last Update
August 12 2022
Active Locations (1)
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1
Dpt of OncoHematology - Fondazione Centro San Raffaele del Monte Tabor
Milan, Italy