AvR-CHOP : Feasibility Study of Induction and Maintenance Avelumab Plus R-CHOP in Patients With Diffuse Large B Cell Lymphoma (DLBCL)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy,Treatment | Blood / Myeloma / LymphomaB-Cell Non Hodgkin Lymphoma,Diffuse Large Cell Lymphoma,Lymphoma,

Trial Overview Read MoreRead more

This phase I trial is assessing induction and maintenance therapy (with Avelumab and R-CHOP chemotherapy) in patients with Diffuse Large B Cell Lymphoma (DLBCL).
 

This trial is treating patients with Diffuse Large B-Cell Lymphoma (DLBCL).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Feasibility Study of Induction and Maintenance Avelumab Plus R-CHOP in Patients With Diffuse Large B Cell Lymphoma (DLBCL)

Commercial Sponsor

Merck

Other Non-Commercial Sponsor

Austin Health

Summary

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.

Recruiting Hospitals Read MoreRead more

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Ballarat Hospital
Ballarat
Ms Carmel Goss
CarmelG@bhs.org.au
03 5320 4735

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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