Ocular Adnexal Mucosa-Associated Lymphoid Tissue LymphomaPhase 2IRISNCT01514344
Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma
A Phase 2 study testing intralesional rituximab and supplemental autologous serum in people with Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma, run by Andres J. M. Ferreri at 1 site in Italy.
Trial summary
Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma
- What is being tested?
- intralesional rituximab and supplemental autologous serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2011to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- concomitant conventional (chemo-, radiation, immuno-), experimental (antibiotic) or corticosteroid anticancer therapy
- known allergy to rituximab
- systemic symptoms
- concurrent diagnosis of pemphigus
- postsurgical conjunctival scars
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor
Milan
About this study
Official title: Phase II Study on Activity and Tolerability of Intralesional Rituximab in Patients With Relapsed or Refractory CD20+ Indolent Lymphomas of Conjunctiva; Activity of Supplemental Autologous Serum in Patients Not Responsive to Rituximab Alone
Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.
Read the detailed description
Preliminary data suggest intralesional rituximab is able to revert resistance to systemic rituximab in patients with CD20+ indolent lymphoma of the conjunctiva, and the addition of autologous serum seems to exhibit a synergistic effect on tumor regression. These two main aspects will be assessed in this trial.
- Being tested
- intralesional rituximab, supplemental autologous serum
- Keywords
- OAL, MALT, conjunctiva, indolent, CD20+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intralesional rituximabDrug
Also called Intraconjunctival rituximab; mabthera, anti-CD20 therapy
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
supplemental autologous serumBiological
Also called autologous serum supplementation; complement
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
| Study group | Role | What they receive |
|---|---|---|
| intralesional rituximab | Experimental | Not described Receives: Drug: intralesional rituximab; Biological: supplemental autologous serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of safety
assessment of safety of intralesional rituximab in terms of incidence of >/= G4 adverse events during the experimental treatment
Measured: During experimental treatment (within 7 months from trial registration)
Secondary outcomes (1)
assessment of activity
assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response
Measured: at the end of experimental treatment (at 7th month from trial registration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2014
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular Adnexal Mucosa-Associated Lymphoid Tissue LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andres J. M. Ferreri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andres J. M. Ferreri, IRCCS San Raffaele
- Investigators
- Andrés JM Ferreri, MD, Study chair, San Raffaele Scientific Institute, Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514344
- Sponsor's protocol ID
- IRIS
- Acronym
- IRIS
- Status last verified
- Aug 2022
- First submitted
- 6 Jan 2012
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32182364
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on Activity and Tolerability of Intralesional Rituximab in Patients With Relapsed or Refractory CD20+ Indolent Lymphomas of Conjunctiva; Activity of Supplemental Autologous Serum in Patients Not Responsive to Rituximab Alone
- ClinicalTrials.gov ID
- NCT01514344
- Acronym / sponsor ID
- IRIS / IRIS
- Keywords
- OAL, MALT, conjunctiva, indolent, CD20+
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Andres J. M. FerreriUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.
Detailed description
Preliminary data suggest intralesional rituximab is able to revert resistance to systemic rituximab in patients with CD20+ indolent lymphoma of the conjunctiva, and the addition of autologous serum seems to exhibit a synergistic effect on tumor regression. These two main aspects will be assessed in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intralesional rituximab | Experimental | Drug: intralesional rituximab, Biological: supplemental autologous serum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- concomitant conventional (chemo-, radiation, immuno-), experimental (antibiotic) or corticosteroid anticancer therapy
- known allergy to rituximab
- systemic symptoms
- concurrent diagnosis of pemphigus
- postsurgical conjunctival scars
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intralesional rituximabAlso: Intraconjunctival rituximab; mabthera, anti-CD20 therapy10-20 mg (1-2 ml) rituximab once a week for 4 weeks; followed by 10-20 mg (1-2 ml) rituximab monthly per six months | Drug | intralesional rituximab |
| supplemental autologous serumAlso: autologous serum supplementation; complementpatients 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 | Biological | intralesional rituximab |
Primary outcome
assessment of safety
Time frame: During experimental treatment (within 7 months from trial registration)
assessment of safety of intralesional rituximab in terms of incidence of >/= G4 adverse events during the experimental treatment
1 secondary outcome
assessment of activity
Time frame: at the end of experimental treatment (at 7th month from trial registration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Derived from this study: PubMed 32182364Ferreri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrés JM Ferreri, MD study chair
San Raffaele Scientific Institute, Milano, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intralesional rituximab and supplemental autologous serum in people with Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma, run by Andres J. M. Ferreri at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of safety (time frame: During experimental treatment (within 7 months from trial registration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01514344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.