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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 2
18 Years
N/A
Open (Enrolling)
Both
Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

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Trial Information

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


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.


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
- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

assessment of safety

Outcome Description:

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

Outcome Time Frame:

During experimental treatment (within 7 months from trial registration)

Safety Issue:

Yes

Principal Investigator

Andrés JM Ferreri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Raffaele Scientific Institute, Milano, Italy

Authority:

Italy: Ethics Committee

Study ID:

IRIS

NCT ID:

NCT01514344

Start Date:

December 2011

Completion Date:

October 2015

Related Keywords:

  • Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma
  • OAL
  • MALT
  • conjunctiva
  • indolent
  • CD20+
  • Lymphoma
  • Lymphoma, B-Cell, Marginal Zone

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