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

Primary Purpose

Non-Hodgkin Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
doxycycline (tetracycline)
Sponsored by
International Extranodal Lymphoma Study Group (IELSG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring NHL of the ocular adnexae

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital del Salvador
  • Ospedale San Raffaele, Department of Oncology
  • S. Matteo
  • A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia
  • Hospital Ramon y Cajal
  • IOSI

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

doxycycline

Arm Description

doxycycline 100 mg twice daily for 3 weeks

Outcomes

Primary Outcome Measures

response rates

Secondary Outcome Measures

Full Information

First Posted
August 27, 2009
Last Updated
November 22, 2013
Sponsor
International Extranodal Lymphoma Study Group (IELSG)
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1. Study Identification

Unique Protocol Identification Number
NCT01010295
Brief Title
A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae
Acronym
IELSG27
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Extranodal Lymphoma Study Group (IELSG)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma
Keywords
NHL of the ocular adnexae

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
doxycycline
Arm Type
Experimental
Arm Description
doxycycline 100 mg twice daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
doxycycline (tetracycline)
Intervention Description
doxycycline 100 mg twice daily for 3 weeks
Primary Outcome Measure Information:
Title
response rates
Time Frame
at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrés JM Ferreri, MD
Organizational Affiliation
International Extranodal Lymphoma Study Group
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital del Salvador
City
Providencia, Santiago
Country
Chile
Facility Name
Ospedale San Raffaele, Department of Oncology
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
S. Matteo
City
Pavia
Country
Italy
Facility Name
A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia
City
Reggio Calabria
Country
Italy
Facility Name
Hospital Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
IOSI
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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