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Phase II Clinical Trial on the Activity of Salvage Therapy With High Dose Oral Clarithromycin in Patients With Relapsed or Refractory Extranodal Marginal Zone Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Phase II Clinical Trial on the Activity of Salvage Therapy With High Dose Oral Clarithromycin in Patients With 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.


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
- 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 (creatinine
- 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

assessment of responses

Outcome Description:

evaluation of activity in terms of global responses, complete responses and duration of responses

Outcome Time Frame:

The best clinical response at 6 months from trial registration

Safety Issue:

Yes

Principal Investigator

Andrés JM Ferreri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Raffaele Scientific Institute, Milano, Italy

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

HD-K

NCT ID:

NCT01516606

Start Date:

January 2012

Completion Date:

December 2014

Related Keywords:

  • Lymphoma
  • MALT
  • refractory
  • relapsed
  • extranodal
  • relapsed or refractory extranodal marginal zone lymphoma
  • Lymphoma
  • Lymphoma, B-Cell, Marginal Zone

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