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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT01820910
First received: March 26, 2013
Last updated: July 26, 2016
Last verified: July 2016
  Purpose
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 Intervention Phase
Marginal Zone Lymphoma of Ocular Adnexal Drug: Doxycycline Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):

Primary Outcome Measures:
  • progression-free survival (PFS) [ Time Frame: 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


Enrollment: 34
Study Start Date: March 2013
Estimated Study Completion Date: September 2023
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820910

Locations
Italy
AO Ospedali Riuniti Papardo Piemonte
Messina, Italy
Ospedale San Raffaele
Milan, Italy
Ematologia
Parma, Italy
Ospedale Civile
Piacenza, Italy
Università La Sapienza
Rome, Italy
Molinette 1
Torino, Italy
Ospedale dell'Angelo
Venezia Mestre, Italy
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Investigators
Study Chair: Andrés Ferreri, MD Ospedale San Raffaele, Milan, Italy
  More Information

Responsible Party: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT01820910     History of Changes
Other Study ID Numbers: IELSG39
Study First Received: March 26, 2013
Last Updated: July 26, 2016

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on June 23, 2017