NCT01010295

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 25, 2013

Status Verified

May 1, 2012

Enrollment Period

5.3 years

First QC Date

August 27, 2009

Last Update Submit

November 22, 2013

Conditions

Non-Hodgkin Lymphoma

Keywords

NHL of the ocular adnexae

Outcome Measures

Primary Outcomes (1)

  • response rates

    at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline

Study Arms (1)

doxycycline

EXPERIMENTAL

doxycycline 100 mg twice daily for 3 weeks

Drug: doxycycline (tetracycline)

Interventions

doxycycline (tetracycline)DRUG

doxycycline 100 mg twice daily for 3 weeks

doxycycline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital del Salvador

Providencia, Santiago, Chile

Location

Ospedale San Raffaele, Department of Oncology

Milan, Milan, 20132, Italy

Location

S. Matteo

Pavia, Italy

Location

A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia

Reggio Calabria, Italy

Location

Hospital Ramon y Cajal

Madrid, Spain

Location

IOSI

Bellinzona, 6500, Switzerland

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

DoxycyclineTetracycline

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • AndrĂ©s JM Ferreri, MD

    International Extranodal Lymphoma Study Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2009

First Posted

November 10, 2009

Study Start

September 1, 2006

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

November 25, 2013

Record last verified: 2012-05

Locations

CL(1)ES(1)IT(3)CH(1)