RecruitingPhase 2NCT06765317

A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma

Optimizing Frontline Therapy for DLBCL in Older Adults: A GLOfitamab-based, Response-adapted, Window-stYle Study (GLORY)


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

42 participants

Start Date

Jan 16, 2025

Study Type

INTERVENTIONAL

Summary

The researchers are doing this study to find out if the study treatment is an effective treatment that causes few or mild side effects in people with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), or transformed lymphoma. The treatment being tested in this study is glofitamab, polatuzumab, and obinutuzumab in combination with standard treatment (the combination of rituximab, cyclophosphamide, doxorubicin, and prednisone, or R-miniCHP).


Eligibility

Min Age: 65 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing glofitamab — a newer type of immunotherapy drug — in older or frail patients with aggressive B-cell lymphoma (including diffuse large B-cell lymphoma) who have not yet received treatment. It's designed for patients who are typically too weak for standard intensive chemotherapy. **You may be eligible if...** - You are 65-79 years old and have been assessed as unfit or frail, OR you are 80 or older regardless of fitness level - You have been diagnosed with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or transformed lymphoma - You have not yet received any systemic treatment for lymphoma - Your heart function is adequate (ejection fraction of 45% or higher) - You have at least one measurable tumor lesion **You may NOT be eligible if...** - You have already received prior treatment for lymphoma (short-term steroids are an exception) - Your heart function is too weak to tolerate anthracycline-based chemotherapy - Your overall health is too poor (ECOG score above 2) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlofitamab

C1D8 2.5 mg iv; C1D15 10 mg iv; C2D1-onwards: 30 mg iv, every 3 weeks

DRUGPolatuzumab

1.8 mg/kg iv C1D1 onwards, every 3 weeks

DRUGRituximab

375 mg/m2 iv D1

DRUGCyclophosphamide

400 mg/m2 iv D1

DRUGDoxorubicin

25 mg/m2 iv D1

DRUGObinutuzumab:

1000 mg iv C1D1 (7 days prior to glofitamab administration) single dose


Locations(7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06765317