NCT01516606

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

January 6, 2012

Last Update Submit

August 10, 2022

Conditions

Lymphoma

Keywords

MALTrefractoryrelapsedextranodalrelapsed or refractory extranodal marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Drug: clarithromycin, oral, high dose

Interventions

clarithromycin, oral, high doseDRUG

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
clarithromycin, oral, high dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt of OncoHematology - Fondazione Centro San Raffaele del Monte Tabor

Milan, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25935794DERIVED

MeSH Terms

Conditions

LymphomaRecurrence

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Andrés JM Ferreri, MD

    San Raffaele Scientific Institute, Milano, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 25, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations

IT(1)