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

Phase 2

Completed

• Conditions: Non-Hodgkin Lymphoma
• Interventions: Drug: doxycycline (tetracycline)

• Registration Number: NCT01010295
• Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)

Brief Summary

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).

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Primary Completion: 2011-12
• Status Verified: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2013-11-22
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
doxycycline	doxycycline (tetracycline)	doxycycline 100 mg twice daily for 3 weeks

Primary Outcome Measures

Name	Time	Method
response rates	at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline

Trial Locations

Locations (6)

Hospital del Salvador; 🇨🇱 Providencia, Santiago, Chile

Ospedale San Raffaele, Department of Oncology; 🇮🇹 Milan, Italy

S. Matteo; 🇮🇹 Pavia, Italy

A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia; 🇮🇹 Reggio Calabria, Italy

IOSI; 🇨🇭 Bellinzona, Switzerland

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain