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COALITION : A Multicentre Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18-65Age 18-65

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaB-Cell Non Hodgkin Lymphoma,Chronic Lymphocytic Leukaemia,Diffuse Large Cell Lymphoma,Follicular Lymphoma,Lymphoma,Mantle Cell Lymphoma

Trial Overview Read MoreRead more

This Phase I/II trial is trying to understand how safe and tolerable a targeted therapy drug (glofitamab) is in combination with chemotherapy in people with higher-risk Diffuse Large B-Cell Lymphoma or High Grade B-Cell Lymphoma.
 

This trial is treating patients with Diffuse Large B-Cell Lymphoma and High-grade B-Cell lymphoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

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

A Multicentre Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL)

Commercial Sponsor

Hoffmann-La Roche

Other Non-Commercial Sponsor

National Health Service Blood & Transplant

Summary

This randomised trial has two experimental arms. In Experimental Arm 1, participants will receive Glofitamab plus R-CHOP. Participants will receive treatment in 21 day cycles consisting of R-CHOP in cycle 1, followed by R-CHOP plus glofitamab for cycles 2-6, and two cycles of glofitamab monotherapy consolidation. Patients may also receive high-dose methotrexate CNS prophylaxis at investigator discretion. Rituximab 375 mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Cyclophosphamide 750mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Doxorubicin 50mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Vincristine 1.4mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Prednisolone 100mg will be administered orally on Days 1-5 of every 21-day cycle. Glofitamab will be administered by IV infusion as per the schedule specified in the respective arm. In Experimental Arm 2, participants will receive Glofitamab plus polatuzumab vedotin-RCHP. Participants will receive treatment in 21 day cycles consisting of R-CHOP in cycle 1, followed by polatuzumab vedotin-RCHP plus glofitamab for cycles 2-6, and two cycles of glofitamab monotherapy consolidation. Patients may also receive high-dose methotrexate CNS prophylaxis at investigator discretion. Rituximab 375 mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Cyclophosphamide 750mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Doxorubicin 50mg/m^2 will be administered by IV infusion on Day 1 of every 21-day cycle. Prednisolone 100mg will be administered orally on Days 1-5 of every 21-day cycle. Glofitamab will be administered by IV infusion as per the schedule specified in the respective arm.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Prahran
Pushpa Ravi
p.ravi@alfred.org.au
03 9076 2641

Epworth Hospital Haematology
East Melbourne
Dr Connie Barlas
connie.barlas@epworth.org.au
03 9516 2374

Barwon Health, University Hospital Geelong
Geelong
Haematology Team
HaematologyTrials@barwonhealth.org.au

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

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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