Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment

Sponsor
International Extranodal Lymphoma Study Group (IELSG) (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01820910
Collaborator
(none)
34
7
1
126
4.9
0

Study Details

Study Description

Brief Summary

Objective of this trial is to establish the efficacy of an upfront targeted therapy consisting of Chlamydophila psittaci (Cp)-eradicating therapy with prolonged administration of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection re-occurrence in patients with newly diagnosed ocular adnexae marginal zone lymphoma The primary endpoint is the 2-year progression-free survival (PFS) of patients with newly diagnosed stage-IE lymphoma treated with the experimental strategy.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
International Prospective Phase 2 Trial Addressing the Efficacy of First-line Chlamydophila Psittaci-eradicating Therapy With Protracted Administration of Doxycycline Followed by Eradication Monitoring and Antibiotic Re-treatment at Infection Re-occurrence in Patients With Newly Diagnosed Ocular Adnexal Marginal Zone Lymphoma (OAMZL)
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
May 1, 2016
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Doxycycline

Drug: Doxycycline
All enrolled patients will be treated with doxycycline 100 mg bid daily, orally, for four weeks followed by four weeks rest, repeated for three cycles. Response will be assessed by MRI (magnetic resonance imaging) and ophthalmologic examination at the end of the planned treatment. Patients who will achieve complete response, partial response or have a stable disease at 3 months from upfront doxycycline will be monitored for infection re-occurrence and assessed for response with MRI and ophthalmologist evaluation every six months for the first five years.

Outcome Measures

Primary Outcome Measures

  1. progression-free survival (PFS) [2-year from start of treatment]

    from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Histological diagnosis of marginal zone lymphoma of the ocular adnexae (OAMZL)

  2. Single or bilateral lesion (stage IE) localised to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue, eyelid)

  3. Absence of B symptoms

  4. Previously untreated patients

  5. No systemic antibiotic therapy in the last three months before enrolment

  6. Age >18 years

  7. ECOG PS 0-2

  8. Negative HIV, HBV and HCV serology

  9. Adequate bone marrow, renal, and hepatic function

  10. No previous or concurrent malignancies with the exception of surgically cured carcinoma in situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least from 5 years

  11. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

  12. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation

  13. No concurrent treatment with other experimental drugs

  14. Patient-signed informed consent obtained before registration

Exclusion Criteria:
  1. Pregnant or lactating women

  2. Known allergy to tetracycline

  3. Patients unwilling to comply with the requirements of follow-up

  4. Myasthenia gravis (tetracycline can exacerbate muscle weakness)

  5. Systemic lupus erythematous (tetracycline can exacerbate this condition)

  6. Patients with large or rapidly enlarging tumors requiring immediate radiotherapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 AO Ospedali Riuniti Papardo Piemonte Messina Italy
2 Ospedale San Raffaele Milan Italy
3 Ematologia Parma Italy
4 Ospedale Civile Piacenza Italy
5 Università La Sapienza Rome Italy
6 Molinette 1 Torino Italy
7 Ospedale dell'Angelo Venezia Italy

Sponsors and Collaborators

  • International Extranodal Lymphoma Study Group (IELSG)

Investigators

  • Study Chair: Andrés Ferreri, MD, Ospedale San Raffaele, Milan, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT01820910
Other Study ID Numbers:
  • IELSG39
First Posted:
Mar 29, 2013
Last Update Posted:
Jul 14, 2022
Last Verified:
Jul 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2022