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

Primary Purpose

Marginal Zone Lymphoma of Ocular Adnexal

Status
Active
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Doxycycline
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 Marginal Zone Lymphoma of Ocular Adnexal

Eligibility Criteria

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

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

Sites / Locations

  • AO Ospedali Riuniti Papardo Piemonte
  • Ospedale San Raffaele
  • Ematologia
  • Ospedale Civile
  • Università La Sapienza
  • Molinette 1
  • Ospedale dell'Angelo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Doxycycline

Arm Description

Outcomes

Primary Outcome Measures

progression-free survival (PFS)
from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up

Secondary Outcome Measures

Full Information

First Posted
March 26, 2013
Last Updated
May 17, 2023
Sponsor
International Extranodal Lymphoma Study Group (IELSG)
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1. Study Identification

Unique Protocol Identification Number
NCT01820910
Brief Title
Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma 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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marginal Zone Lymphoma of Ocular Adnexal

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Doxycycline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression-free survival (PFS)
Description
from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up
Time Frame
2-year from start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological diagnosis of marginal zone lymphoma of the ocular adnexae (OAMZL) Single or bilateral lesion (stage IE) localised to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue, eyelid) Absence of B symptoms Previously untreated patients No systemic antibiotic therapy in the last three months before enrolment Age >18 years ECOG PS 0-2 Negative HIV, HBV and HCV serology Adequate bone marrow, renal, and hepatic function 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 Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation No concurrent treatment with other experimental drugs Patient-signed informed consent obtained before registration Exclusion Criteria: Pregnant or lactating women Known allergy to tetracycline Patients unwilling to comply with the requirements of follow-up Myasthenia gravis (tetracycline can exacerbate muscle weakness) Systemic lupus erythematous (tetracycline can exacerbate this condition) Patients with large or rapidly enlarging tumors requiring immediate radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrés Ferreri, MD
Organizational Affiliation
Ospedale San Raffaele, Milan, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
AO Ospedali Riuniti Papardo Piemonte
City
Messina
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milan
Country
Italy
Facility Name
Ematologia
City
Parma
Country
Italy
Facility Name
Ospedale Civile
City
Piacenza
Country
Italy
Facility Name
Università La Sapienza
City
Rome
Country
Italy
Facility Name
Molinette 1
City
Torino
Country
Italy
Facility Name
Ospedale dell'Angelo
City
Venezia
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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