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Feasibility Study of Induction and Maintenance Avelumab Plus R-CHOP in Patients With Diffuse Large B Cell Lymphoma (DLBCL)
Other Non-Commercial Sponsor
The rationale and primary objective of this trial is to evaluate the feasibility of adding induction and maintenance Avelumab into the standard Rituximab, Cyclophosphamide, Doxyrubicin, Vincristine and Prednisolone (RCHOP) chemotherapy regimen, in order to examine the effect of programmed death-ligand 1(PDL1) inhibition in patients with stage II, III and IV DLBCL.
Primary endpoint: Immune related toxicity which requires discontinuation of Avelumab.
Secondary endpoints include- Response rates (according to the Lugano classification for Response Criteria for Non Hodgkin Lymphoma); failure free survival; Overall survival; and overall toxicity of treatment (according to CTCAE v 4.0).
All patients (n=28) will receive Avelumab and rituximab 2 weekly for 2 cycles, then RCHOP chemotherapy 3 weekly for 6 cycles then Avelumab 2 weekly for 6 cycles.
Patients will be reviewed at baseline and prior to each cycle of treatment for toxicity.Positron emission tomography-computed tomography (PET/CT) will be performed at baseline, after induction phase, after cycle 2 RCHOP, at end of Avelumab (Av) RCHOP and at end of maintenance phase Avelumab. Following completion of treatment, patients will be followed up for a total of 5 years (at 3,6,9,12,18,24,36,48 and 60 months posttreatment). No formal routine imaging will be performed during follow up. In patients with relapse, follow up only for survival will be every 3 months.