A Phase 2 interventional study of clarithromycin, oral, high dose in Lymphoma, sponsored by Andres J. M. Ferreri. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-12.
Sponsored by Andres J. M. Ferreri · Phase 2, Interventional, and Treatment
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.
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.
5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.
This study's enrollment of 23 is below the median of 40 across 4,534 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Andres J. M. Ferreri is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total
Drug: 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
Also known as: klacid
assessment of responses
evaluation of activity in terms of global responses, complete responses and duration of responses
Time frame: The best clinical response at 6 months from trial registration
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clarithromycin
Andres J. M. Ferreri