NCT01514344

Brief Summary

Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

2.8 years

First QC Date

January 6, 2012

Last Update Submit

August 2, 2022

Conditions

Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Keywords

OALMALTconjunctivaindolentCD20+

Outcome Measures

Primary Outcomes (1)

  • assessment of safety

    assessment of safety of intralesional rituximab in terms of incidence of \>/= G4 adverse events during the experimental treatment

    During experimental treatment (within 7 months from trial registration)

Secondary Outcomes (1)

  • assessment of activity

    at the end of experimental treatment (at 7th month from trial registration)

Study Arms (1)

intralesional rituximab

EXPERIMENTAL
Drug: intralesional rituximabBiological: supplemental autologous serum

Interventions

intralesional rituximabDRUG

10-20 mg (1-2 ml) rituximab once a week for 4 weeks; followed by 10-20 mg (1-2 ml) rituximab monthly per six months

Also known as: Intraconjunctival rituximab; mabthera, anti-CD20 therapy
intralesional rituximab
supplemental autologous serumBIOLOGICAL

patients in PD or SD during or after administration of 6 doses monthly rituximab will be administered the same dose of intralesional rituximab supplemented by autologous serum

Also known as: autologous serum supplementation; complement
intralesional rituximab

Eligibility Criteria

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

You may qualify if:

  • histological diagnosis of CD20+ B cell lymphoma subtypes: marginal zone lymphoma, grade 1-2 follicular lymphoma, plasmocytic lymphoma, small lymphocyte lymphoma
  • conjunctival localization alone (1EA stage; mono- or bilateral)
  • at least one measurable lesion
  • age \>/= 18 years
  • ECOG-PS \</=3
  • HIV 1-2 negativity
  • at least one previous treatment (antibiotic or rituximab)

You may not qualify if:

  • concomitant conventional (chemo-, radiation, immuno-), experimental (antibiotic) or corticosteroid anticancer therapy
  • known allergy to rituximab
  • systemic symptoms
  • concurrent diagnosis of pemphigus
  • postsurgical conjunctival scars

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor

Milan, Italy

Location

Related Publications (1)

  • Ferreri AJM, Sassone M, Miserocchi E, Govi S, Cecchetti C, Corti ME, Mappa S, Arcaini L, Zaja F, Todeschini G, Mannina D, Calimeri T, Perrone S, Ponzoni M, Modorati G. Treatment of MALT lymphoma of the conjunctiva with intralesional rituximab supplemented with autologous serum. Blood Adv. 2020 Mar 24;4(6):1013-1019. doi: 10.1182/bloodadvances.2020001459.

    PMID: 32182364DERIVED

MeSH Terms

Interventions

RituximabComplement System Proteins

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Andrés JM Ferreri, MD

    San Raffaele Scientific Institute, Milano, Italy

    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 INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 23, 2012

Study Start

December 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2019

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations

IT(1)