A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae (IELSG27)

November 22, 2013 updated by: International Extranodal Lymphoma Study Group (IELSG)

A Clinico-pathological Phase II Study With Translational Elements to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae With Particular Reference to Chlamydia Species and the Effects of MALT Lymphoma Treatment With Tetracycline

Patients with mucosa-associated lymphoid tissue (MALT) lymphoma of the ocular adnexae (MLOA) will be eligible for treatment with doxycycline (part A: clinico-pathological study); patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline can participate in the only pathologic study (part B).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with suspected lymphoma of the ocular adnexae will undergo a diagnostic biopsy in the usual way. If lymphoma is confirmed the patient will undergo a full staging evaluation and entry into either part A or B of the study will then be considered as follows:

  • clinico-pathological (part A) for patients with MALT lymphoma of the ocular adnexae (MLOA) and eligible for treatment with Doxycycline 100 mg twice daily for 3 weeks ; or
  • pathology only (part B) for patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Providencia, Santiago, Chile
        • Hospital del Salvador
  • Italy
      • Milan, Italy, 20132
        • Ospedale San Raffaele, Department of Oncology
      • Pavia, Italy
        • S. Matteo
      • Reggio Calabria, Italy
        • A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia
  • Spain
      • Madrid, Spain
        • Hospital Ramon y Cajal
  • Switzerland
      • Bellinzona, Switzerland, 6500
        • IOSI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 years or over
  2. Histologically confirmed marginal zone B-cell lymphoma of MALT-type
  3. Lymphoma localised to the ocular adnexae (conjunctiva, lacrimal gland, orbit soft tissue, clinical stage IEA) following a CT scan of neck, thorax, abdomen and pelvis, bone marrow aspirate/trephine, full blood count and biochemical profile
  4. No previous treatment, excepting RT for localised lymphoma of the contralateral eye
  5. At least one measurable lesion
  6. No systemic antibiotic therapy in the last three months
  7. No other malignancy in the previous 5 years apart from appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
  8. In women with reproductive potential a willingness to use contraception from entry into the study for a period of 3 months
  9. Written informed consent

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Known allergy to tetracycline
  3. Patients unwilling to comply with the requirements of follow-up as defined by this protocol
  4. Myasthenia gravis (tetracycline can exacerbate muscle weakness)
  5. Systemic lupus erythematous (tetracycline can exacerbate the condition)
  6. Patients with large or rapidly enlarging tumours requiring immediate radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: doxycycline
doxycycline 100 mg twice daily for 3 weeks
Drug: doxycycline (tetracycline)
doxycycline 100 mg twice daily for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response rates
Time Frame: at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline
at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Extranodal Lymphoma Study Group (IELSG)

Investigators

  • Study Chair: Andrés JM Ferreri, MD, International Extranodal Lymphoma Study Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

August 27, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (Estimate)

November 10, 2009

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 22, 2013

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IELSG27
  • EudraCT number 2006-005795-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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