Non-Hodgkin LymphomaPhase 2IELSG27NCT01010295
A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae
A Phase 2 study testing doxycycline (tetracycline) in people with Non-Hodgkin Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 6 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- doxycycline (tetracycline)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Sep 2006to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Italy3 sites
Ospedale San Raffaele, Department of Oncology
Milan, Milan, 20132
S. Matteo
Pavia
A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia
Reggio Calabria
About this study
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
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).
Read the 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.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- doxycycline (tetracycline)
- Keywords
- NHL of the ocular adnexae
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycycline (tetracycline)Drug
doxycycline 100 mg twice daily for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| doxycycline | Experimental | doxycycline 100 mg twice daily for 3 weeks Receives: Drug: doxycycline (tetracycline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rates
Measured: at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startSep 2006
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrés JM Ferreri, MD, Study chair, International Extranodal Lymphoma Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010295
- Sponsor's protocol ID
- IELSG27
- Other IDs
- EudraCT number 2006-005795-41
- Acronym
- IELSG27
- Status last verified
- May 2012
- First submitted
- 27 Aug 2009
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01010295
- Acronym / sponsor ID
- IELSG27 / IELSG27
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- NHL of the ocular adnexae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| doxycycline | Experimental | Drug: doxycycline (tetracycline)doxycycline 100 mg twice daily for 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxycycline (tetracycline)doxycycline 100 mg twice daily for 3 weeks | Drug | doxycycline |
Primary outcome
response rates
Time frame: at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrés JM Ferreri, MD study chair
International Extranodal Lymphoma Study Group
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing doxycycline (tetracycline) in people with Non-Hodgkin Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Chile, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rates (time frame: at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013; AzTrials last refreshed its copy on 6 Nov 2026.