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NCT Number: NCT01010295

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital del Salvador, Providencia, Santiago, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or over
  • Histologically confirmed marginal zone B-cell lymphoma of MALT-type
  • 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
  • No previous treatment, excepting RT for localised lymphoma of the contralateral eye
  • At least one measurable lesion
  • No systemic antibiotic therapy in the last three months
  • 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
  • In women with reproductive potential a willingness to use contraception from entry into the study for a period of 3 months
  • Written informed consent

Exclusion criteria

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

Treatment and study plan

doxycycline (tetracycline)

Drug

doxycycline 100 mg twice daily for 3 weeks

Primary outcomes

  1. response rates

    Time frame: at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline

Sponsors and collaborators

Lead sponsor

International Extranodal Lymphoma Study Group (IELSG)

Other

Registry information

Official study title

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

Acronym: IELSG27

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Nov 10, 2009
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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