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

Recruiting in Palo Alto (17 mi)

Overseen byJohn Kuruvilla, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This is a phase ll study of participants with untreated diffuse large B Cell lymphoma (DLBCL).

Research Team

John Kuruvilla, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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.

Inclusion Criteria

I am 18 or older and eligible for Pola-R-CHP and glofitamab treatment.

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

I am using or willing to use effective birth control during and after the treatment.

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Exclusion Criteria

I have been treated with drugs like anthracycline, rituximab, or CD3 targeted therapy.

I have no active cancer except for certain skin cancers, in situ cervical cancer, or any cancer I've been free from for 2+ years.

I do not have an active infection and have not been hospitalized for an infection or treated with IV antibiotics in the last 4 weeks.

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Treatment Details

Interventions

Glofitamab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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