Actively Recruiting
Optimizing Frontline Therapy for Diffuse Large B-cell Lymphoma in Older Adults Using a Glofitamab-based, Response-adapted Treatment Approach
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-05
42
Participants Needed
8
Research Sites
N/A
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
Researchers are evaluating a combination treatment involving glofitamab, polatuzumab, and obinutuzumab alongside standard therapy for older adults with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), or transformed lymphoma. This Phase 2 study aims to determine if this combination is effective and causes few or mild side effects in patients aged 65 to 79 years or older. The study is led by Memorial Sloan Kettering Cancer Center and focuses on optimizing frontline therapy for these lymphoma types in older adults. Participants will receive an initial 2 cycles of glofitamab and polatuzumab followed by an interim PET scan to assess response. If the scan is negative, they will get 4 cycles of the combined treatment with glofitamab, polatuzumab, and R-miniCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone). If the scan is positive but shows partial response or stable disease, participants will receive 6 cycles of the combination, omitting polatuzumab in the last 2 cycles to maintain standard dosing. Drug doses and administration schedules are specified for each medication. During the study, participants will undergo assessments including PET scans to monitor treatment response and other evaluations to measure organ function and side effects. The primary outcome is the complete response rate at one year. Safety and treatment effects will be closely monitored throughout the study period. Participants must comply with study procedures and attend scheduled visits for evaluations. The total duration involves multiple treatment cycles and follow-up assessments to understand the treatment's impact on lymphoma.
CONDITIONS
Brief 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 to 79 years with unfit or frail fitness assessment
- Age 80 years or 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 (except limited prednisone use)
- Ann Arbor Stage 2 bulky, 3, or 4 disease
- Any International Prognostic Index (IPI) score
- Left ventricular ejection fraction (LVEF) of 45% or higher
- At least one measurable lesion by CT or MRI
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Adequate organ and marrow function as defined by specific blood counts and liver/kidney tests
- Negative HIV test or stable HIV with controlled viral load and CD4 count above 200
- Signed informed consent
- Ability to comply with study procedures
- Female patients must be postmenopausal or surgically sterile
- Male participants must agree to contraception or abstinence during and after treatment as specified
You will not qualify if you...
- Prior systemic anti-lymphoma therapy
- Prior solid organ or allogeneic stem cell transplantation
- Active central nervous system involvement
- Uncontrolled HIV, active hepatitis B or C infections (with some exceptions for controlled cases)
- Uncontrolled active systemic infections
- Major surgery within 4 weeks before treatment start
- Significant cardiovascular disease or recent heart events
- Uncontrolled autoimmune disorders
- History of progressive multifocal leukoencephalopathy
- Any life-threatening illness or condition compromising safety
- Inability to comply with study procedures
- Contraindications or allergies to study drugs
- Prior immune therapies within 4 weeks or certain monoclonal antibodies within 3 months
- Prior radiotherapy to mediastinal/pericardial area
- High-dose corticosteroid use beyond specified limits
- Recent use of live attenuated vaccines
- History of other malignancies that may affect study compliance or results, with some exceptions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles, each cycle approximately 3 weeks
Participants receive a Glofitamab-based treatment regimen including Glofitamab, Polatuzumab, Rituximab, Cyclophosphamide, Doxorubicin, and Obinutuzumab. Treatment is response-adapted based on an interim PET scan after 2 cycles, with further cycles adjusted accordingly.
Visits every 3 weeks for treatment administration and assessments
Trial Site Locations
Total: 8 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Hackensack Meridian Health (Data collection only)
Hackensack, New Jersey, United States, 07601
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
P
Pallawi Torka, MD
P
Paul Hamlin, MD
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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