Diffuse large B cell lymphoma Non Hodgkins lymphoma
Conditions
Interventions
Agent
Dose/day Route of administration Days
rituximab
250 mg/m2 Intravenously -14
Ibritumomab
0,4 mCi/kg Intravenously -14
Cyclophosphamide 1200
mg/m2 Intravenously -5 -4,-3,-2
Fludarabine
30 mg
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: By histology confirmed CD20+ DLBCL de novo, relapsed after autologous stem cell transplantation At least partial response according to the Cheson criteria, before entering the protocol, by the use of a salvage chemotherapy regimen age 18-65 years
Exclusion criteria
Exclusion criteria: previous diagnosis of follicular lymphoma primary cerebral lymphoma or cerebral localisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective * To determine the feasibility (as measured by non-relapse mortality after 7 months) of the regimen of Ibritumomab, followed by a reduced intensity, partial T cell-depleted allogeneic stem cell transplantation and immunomodulation with lenalidomide and DLI in patients with relapsed diffuse large B-cell Non-Hodgkin*s lymphoma | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives * To determine the feasibility of the proposed regimen by measurement of GvHD * To determine the feasibility of the proposed regimen by measurement of infections * grade 3 according to CTCAE 4.0. * To determine the percentage of patient with graft failure * To describe the progression free and overall survival of patients * To explore the effect of lenalidomide and DLI after T cell depleted stem cell transplantation on the T and NK cells * To explore relationships between different subtypes of DLBCL / immunohistochemical markers and progression free survival/ GvHD | — |
Countries
Netherlands
Outcome results
None listed