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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin Lymphoma

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Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

response rates

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Andrés JM Ferreri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

International Extranodal Lymphoma Study Group

Authority:

Switzerland: Swissmedic

Study ID:

IELSG27

NCT ID:

NCT01010295

Start Date:

September 2006

Completion Date:

May 2012

Related Keywords:

  • Non-Hodgkin Lymphoma
  • NHL of the ocular adnexae
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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