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Monoclonal Antibodies

Glofitamab for Diffuse Large B-Cell Lymphoma (GRAIL Trial)

Phase 2

Waitlist Available

Led By John Kuruvilla, FRCPC

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologic diagnosis of DLBCL and variants according to the WHO 201613 or WHO 202254 classification including DLBCL non-organ-specific (NOS), Germinal centre B-cell type, activated B-cell type, T-cell/histiocyte-rich large B-cell lymphoma, Epstein-Barr Virus (EBV) + DLBCL, Primary mediastinal/thymic large B-cell lymphoma, High grade B-cell lymphoma with myelocytomatosis oncogene (MYC) and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements, High grade B cell lymphoma NOS including lymphomas transformed from previously untreated indolent lymphomas

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through year 2

Awards & highlights

GRAIL Trial Summary

This trial tests a new cancer drug for people with DLBCL who haven't been treated yet.

Who is the study for?

This trial is for adults with untreated Diffuse Large B-Cell Lymphoma who can undergo full-dose Pola-R-CHP and possibly glofitamab treatment. They must have a measurable mass, normal heart function, and agree to use effective contraception. Exclusions include drug or alcohol abuse, hypersensitivity to study drugs, other cancers requiring active treatment (with some exceptions), significant cardiovascular disease, uncontrolled diseases like diabetes or autoimmune disorders, active infections including HIV unless stable on therapy.Check my eligibility

What is being tested?

The GRAIL trial is testing the feasibility of using Glofitamab in treating DLBCL patients. It's a phase II study that includes interim assessments with FDG PET scans and ctDNA analysis to optimize primary therapy based on individual responses.See study design

What are the potential side effects?

While specific side effects are not listed here, potential side effects may include reactions related to monoclonal antibodies such as infusion reactions or allergic responses; organ inflammation due to immune system activation; fatigue; blood disorders; increased risk of infection.

GRAIL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of aggressive lymphoma.

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I can take care of myself and am up and about more than half of my waking hours.

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I have a tumor that can be measured on scans, larger than 1.5 cm if in a lymph node or 1.0 cm if elsewhere.

GRAIL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through year 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To demonstrate the feasibility of a ctDNA and FDG-PET interim response adapted approach (iRAAp) for the primary therapy of DLBCL

Secondary outcome measures

Event-free survival (EFS)

Incidence of treatment emergent adverse events

Overall survival (OS) at 12 months and 24 months

+2 more

GRAIL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pola-R-CHP and glofitamabExperimental Treatment1 Intervention

High-risk group: Cycle 3-6 polatuzumab vedotin 1.8 mg/kg, cyclophosphamide 750 mg/m2 and doxorubicin 50 mg/m2 on day 1, prednisone 100 mg daily days 1-5, rituximab 375 mg/m2 within 72 hours of polatuzumab vedotin and Glofitamab 2.5 mg Cycle 3 Day 8 and 10 mg on Day 15 Cycles 3-6

Group II: Pola-R-CHPActive Control1 Intervention

Protocol induction: Cycle 1-2 Low-risk group: Cycle 3-4 polatuzumab vedotin 1.8 mg/kg, cyclophosphamide 750 mg/m2 and doxorubicin 50 mg/m2 on day 1, prednisone 100 mg daily days 1-5, and rituximab 375 mg/m2 within 72 hours of polatuzumab vedotin Cycle 5-6 rituximab 375 mg/m2 on day 1 of cycle 5 and cycle 6

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,479 Total Patients Enrolled

John Kuruvilla, FRCPCPrincipal InvestigatorUniversity Health Network, Toronto

1 Previous Clinical Trials

76 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What level of safety can patients expect when utilizing Pola-R-CHP and glofitamab?

"Our internal team gave Pola-R-CHP and glofitamab a score of 2, since this is only at the Phase 2 stage with some safety data available but not yet any proof of efficacy."

Answered by AI

Does this research endeavor currently have any open slots for participants?

"As indicated by clinicaltrials.gov, this trial has ceased its search for suitable participants; the first posting was on December 1st 2023 with a last edit on September 18th 2023. Nevertheless, 394 other medical studies are still accepting candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL)

2024. "Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06050694.