Actively Recruiting
A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-30
42
Participants Needed
7
Research Sites
154 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65-79 years with unfit or frail fitness level or age 80 years and older with any fitness level
- Pathologically confirmed diffuse large B-cell lymphoma, high-grade B-cell lymphoma, or transformed lymphoma
- No prior systemic anti-lymphoma therapy (prednisone up to 100 mg daily for 7 days allowed)
- Ann Arbor Stage 2 bulky, 3, or 4 disease
- Any International Prognostic Index (IPI) score
- Eligible for anthracycline treatment with left ventricular ejection fraction (LVEF) ≥ 45%
- At least one measurable lesion larger than 1.5 cm for nodal or 1.0 cm for extranodal by CT or MRI
- Eastern Cooperative Oncology Group performance status ≤ 2
- Adequate organ and marrow function including specific blood counts and liver/kidney tests
- Negative HIV test or stable HIV with controlled viral load and CD4 count ≥ 200/μL
- Signed informed consent
- Ability to comply with study procedures
- Female patients must not be of childbearing potential; male patients must agree to use contraception or abstain as specified
You will not qualify if you...
- Prior systemic anti-lymphoma therapy (except localized radiation, steroids, and antibiotics)
- Prior solid organ or allogeneic stem cell transplantation
- Active central nervous system involvement
- Uncontrolled HIV or active hepatitis B or C infection
- Uncontrolled active systemic infection
- Major surgery within 4 weeks before starting study drug unless fully recovered
- Significant cardiovascular disease including recent myocardial infarction or unstable conditions
- Uncontrolled autoimmune disorders
- History of progressive multifocal leukoencephalopathy
- Life-threatening illness or organ dysfunction that could compromise safety or study outcomes
- Inability to comply with study procedures
- Allergy or severe reaction to study drugs or related antibodies
- Prior immunotherapy or monoclonal antibody treatment within specified timeframes
- Prior radiotherapy to mediastinal/pericardial region
- Corticosteroid use greater than 50 mg/day prednisone equivalent for non-lymphoma reasons
- Recent live attenuated vaccine within 4 weeks prior to treatment
- History of other malignancy affecting compliance unless meeting specific remission or treatment criteria
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
P
Pallawi Torka, MD
CONTACT
P
Paul Hamlin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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