Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

Sponsor
Andres J. M. Ferreri
Study ID
NCT01514344
Phase
PHASE2
Status
Completed

Conditions

  • Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • intralesional rituximab — DRUG
    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 serum — BIOLOGICAL
    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 Details

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

Key Dates

Start date
Dec 31, 2011
Status verified
Aug 2022
Primary completion
Oct 31, 2014
Completion
Oct 31, 2019

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: intralesional rituximab

Primary Outcome Measure

assessment of safety [ Time Frame: During experimental treatment (within 7 months from trial registration) ]