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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clarithromycin, oral, high dose | Experimental | 2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clarithromycin, oral, high dose | Drug | 2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total |
|
| Measure | Description | Time Frame |
|---|---|---|
| assessment of responses | evaluation of activity in terms of global responses, complete responses and duration of responses | The best clinical response at 6 months from trial registration |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrés JM Ferreri, MD | San Raffaele Scientific Institute, Milano, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dpt of OncoHematology - Fondazione Centro San Raffaele del Monte Tabor | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25935794 | Derived | Ferreri AJ, Sassone M, Kiesewetter B, Govi S, Scarfo L, Donadoni G, Raderer M. High-dose clarithromycin is an active monotherapy for patients with relapsed/refractory extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT): the HD-K phase II trial. Ann Oncol. 2015 Aug;26(8):1760-5. doi: 10.1093/annonc/mdv214. Epub 2015 May 1. |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |