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

NCT04914741 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-08-12

No results posted yet for this study

Summary

This is an open label, multi-centre, phase Ib/II, parallel arm study evaluating the safety and tolerability of glofitamab in addition to backbone chemotherapy consisting of R-CHOP or polatuzumab vedotin-RCHP for younger patients with higher-risk Diffuse Large B-cell Lymphoma or High Grade B-Cell Lymphoma.

Conditions

Interventions

DRUG

Rituximab

Rituximab 375 mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle

DRUG

Cyclophosphamide

Cyclophosphamide 750mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle

DRUG

Doxorubicin

Doxorubicin 50mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle

DRUG

Vincristine

Vincristine 1.4mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle

DRUG

Prednisolone

Prednisolone 100mg orally on Days 1-5 of every 21-day cycle

DRUG

Glofitamab

Glofitamab will be administered by IV infusion as per the schedule specified in the respective arm

DRUG

Polatuzumab vedotin

Polatuzumab 1.8mg/kg administered by IV infusion on Day 1 of every 21-day cycle

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Michael Dickinson · Peter MacCallum Cancer Centre & Royal Melbourne Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2023-12-05
Completion
2025-07-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04914741 on ClinicalTrials.gov