NCT06765317 · Memorial Sloan Kettering Cancer Center
A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma
What this study 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.
View original scientific description
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).
Interventions
DRUG
Glofitamab
C1D8 2.5 mg iv; C1D15 10 mg iv; C2D1-onwards: 30 mg iv, every 3 weeks
DRUG
Polatuzumab
1.8 mg/kg iv C1D1 onwards, every 3 weeks
DRUG
Rituximab
375 mg/m2 iv D1
DRUG
Cyclophosphamide
400 mg/m2 iv D1
DRUG
Doxorubicin
25 mg/m2 iv D1
DRUG
Obinutuzumab:
1000 mg iv C1D1 (7 days prior to glofitamab administration) single dose
Primary outcome measures
evaluate the complete response rate (CRR)
Time frame: 1 year
according to the 2014 Lugano Response Criteria
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 65-79 years with a fitness assessment of unfit or frail per simplified GA (Appendix 1, www.filinf.it/epi) 2. Age ≥80 years with any fitness level 3. Pathologically confirmed DLBCL, HGBCL or transformed lymphoma 4. No prior systemic anti-lymphoma therapy (prednisone/equivalent up to 100 mg daily x 7 days is permissible) 5. Ann Arbor Stage 2 bulky, 3 or 4 disease (Appendix 1) 6. Any IPI score (Appendix 1) 7. Anthracycline eligible: LVEF ≥ 45% by echocardiogram or MUGA scan. 8. Must have at least one bi-dimensionally measurable lesion (\>1.5 cm in its largest dimension for nodal lesions, or \>1.0 cm in its largest dimension for extranodal lesions by computerized tomography \[CT\] scan or MRI) 9. Eastern Cooperative Oncology Group performance status ≤ 2 (Appendix 1) 10. Must have adequate organ and marrow status: 1. Absolute neutrophil count (ANC) ≥1,000/mm3 or ≥500/mm3 if due to disease involvement in the bone marrow 2. Platelet count ≥50,000 cells/mm3
Where
- Basking Ridge, New Jersey
- Hackensack, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Rockville Centre, New York
Collaborators
Genentech, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations