Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

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

Cabrini Education and Research Precinct
Malvern
Micheleine Uhe
muhe@cabrini.com.au
(03) 9508 3481

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
Felicity McLeay
PCCTU.HaemB@petermac.org

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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