Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma (IRIS)
This study is currently recruiting participants.
Verified January 2012 by IRCCS San Raffaele
Sponsor:
Andres J. M. Ferreri
Information provided by (Responsible Party):
Andres J. M. Ferreri, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01514344
First received: January 6, 2012
Last updated: January 17, 2012
Last verified: January 2012
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Purpose
Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.
| Condition | Intervention | Phase |
|---|---|---|
|
Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma |
Drug: intralesional rituximab Biological: supplemental autologous serum |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by IRCCS San Raffaele:
Primary Outcome Measures:
- assessment of safety [ Time Frame: During experimental treatment (within 7 months from trial registration) ] [ Designated as safety issue: Yes ]assessment of safety of intralesional rituximab in terms of incidence of >/= G4 adverse events during the experimental treatment
Secondary Outcome Measures:
- assessment of activity [ Time Frame: at the end of experimental treatment (at 7th month from trial registration) ] [ Designated as safety issue: Yes ]assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: intralesional rituximab |
Drug: intralesional rituximab
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
Other Name: Intraconjunctival rituximab; mabthera, anti-CD20 therapy
Biological: supplemental autologous serum
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
Other Name: autologous serum supplementation; complement
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- concomitant conventional (chemo-, radiation, immuno-), experimental (antibiotic) or corticosteroid anticancer therapy
- known allergy to rituximab
- systemic symptoms
- concurrent diagnosis of pemphigus
- postsurgical conjunctival scars
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514344
Contacts
| Contact: Andrés JM Ferreri, MD | +39022643 ext 7649 | ferreri.andres@hsr.it |
| Contact: Silvia Govi, MD | +39022643 ext 7612 | govi.silvia@hsr.it |
Locations
| Italy | |
| Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor | Recruiting |
| Milano, Italy | |
| Contact: Andrés JM Ferreri, MD +39022643 ext 7649 ferreri.andres@hsr.it | |
| Contact: Silvia Govi, MD +39022643 ext 7612 govi.silvia@hsr.it | |
| Principal Investigator: Andrés JM Ferreri, MD | |
Sponsors and Collaborators
Andres J. M. Ferreri
Investigators
| Study Chair: | Andrés JM Ferreri, MD | San Raffaele Scientific Institute, Milano, Italy |
More Information
No publications provided
| Responsible Party: | Andres J. M. Ferreri, MD, IRCCS San Raffaele |
| ClinicalTrials.gov Identifier: | NCT01514344 History of Changes |
| Other Study ID Numbers: | IRIS |
| Study First Received: | January 6, 2012 |
| Last Updated: | January 17, 2012 |
| Health Authority: | Italy: Ethics Committee Italy: The Italian Medicines Agency |
Keywords provided by IRCCS San Raffaele:
|
OAL MALT conjunctiva indolent CD20+ |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell |
Lymphoma, Non-Hodgkin Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013