Back to resultsSalvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma (HD-K)
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
clarithromycin, oral, high dose
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring MALT, refractory, relapsed, extranodal, relapsed or refractory extranodal marginal zone lymphoma
Eligibility Criteria
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)
Sites / Locations
- Dpt of OncoHematology - Fondazione Centro San Raffaele del Monte Tabor
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
clarithromycin, oral, high dose
Arm Description
2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total
Outcomes
Primary Outcome Measures
assessment of responses
evaluation of activity in terms of global responses, complete responses and duration of responses
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01516606
Brief Title
Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma
Acronym
HD-K
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andres J. M. Ferreri
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
MALT, refractory, relapsed, extranodal, relapsed or refractory extranodal marginal zone lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clarithromycin, oral, high dose
Arm Type
Experimental
Arm Description
2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total
Intervention Type
Drug
Intervention Name(s)
clarithromycin, oral, high dose
Other Intervention Name(s)
klacid
Intervention Description
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 Measure Information:
Title
assessment of responses
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrés JM Ferreri, MD
Organizational Affiliation
San Raffaele Scientific Institute, Milano, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Dpt of OncoHematology - Fondazione Centro San Raffaele del Monte Tabor
City
Milan
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
25935794
Citation
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.
Results Reference
derived
Learn more about this trial
Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma
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