Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
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
Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor
Milan, Italy
assessment of safety
assessment of safety of intralesional rituximab in terms of incidence of \>/= G4 adverse events during the experimental treatment
Time frame: During experimental treatment (within 7 months from trial registration)
assessment of activity
assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response
Time frame: at the end of experimental treatment (at 7th month from trial registration)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.