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Phase 2 Study of TPG for Lymphoma

This study is testing a new combination of three drugs—Tafasitamab, Polatuzumab vedotin, and Glofitamab—as a first treatment for people with Diffuse Large B-cell Lymphoma (DLBCL) or High-grade B-cell Lymphoma (HGBL). These are types of B-cell lymphoma, a cancer of the immune system. Researchers want to see how many patients have a complete response (meaning the cancer is no longer detectable) after 3 months of treatment. They are also carefully watching for any side effects. You may be able to join if you are 18 or older and have a confirmed diagnosis of DLBCL or HGBL. This study plans to enroll about 30 participants.

Study design
This is a Phase 2, open-label study, meaning both you and your doctors will know which treatments you are receiving. It is a single-center study, planning to enroll about 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for side effects from the day you give consent until 90 days after your last study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07502872

TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Brown University
~30 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:TafasitamabPolatuzumab vedotinGlofitamabObinutuzumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response rate
Measured over 3 months after starting therapy
+1 more outcome measured

Conditions

Diffuse Large B Cell Lymphoma
High-grade B-cell Lymphoma
Lymphoma
Lymphoma, B-Cell

Explore related trials

Diffuse Large B-Cell LymphomaFollicular LymphomaHigh Grade B-Cell Lymphoma

Where it's being run

1 sites across 1 states
Rhode Island1

Study leadership

  • Adam Olszewski · PRINCIPAL_INVESTIGATOR · Brown University Health

Who to contact

Roxanne Wood
[email protected]
(401) 863-3000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diffuse large B-cell lymphoma, not otherwise specified (NOS)
T-cell/histiocyte-rich large B-cell lymphoma
DLBCL/HGBL with MYC and BCL2 rearrangements
Large B-cell lymphoma with IRF4 rearrangement
HGBL with 11q aberration
EBV-positive diffuse large B-cell lymphoma
DLBCL associated with chronic inflammation
Primary large B-cell lymphoma of immune-privileged sites
Primary cutaneous DLBCL, leg type
Intravascular large B-cell lymphoma
Primary mediastinal large B-cell lymphoma
HGBL, NOS
Grade 3B follicular lymphoma. 4. FDG-avid disease by PET-CT Lugano criteria. 5. No prior systemic therapy for B-cell lymphoma, except for:
corticosteroids;
a single cycle of chemotherapy administered prior to enrollment (to facilitate enrolling patients who require emergent initiation of therapy for rapidly progressive or symptomatic lymphoma);
prior local radiation therapy;
prior treatment for indolent lymphoma. 6. Performance status ECOG 0, 1, or 2. 7. Ability to receive one of the standard chemotherapy regimens for DLBCL/HGBL including attenuated versions, where clinically appropriate 8. Required initial laboratory values: (unless due to underlying lymphoma):
absolute neutrophil count ≥1.0 x 109/L,
platelet count ≥75 x 109/L.
creatinine ≤ 1.5 mg/dL or glomerular filtration rate (GFR) ≥40 mL/min/1.73m2 using the Mayo Quadratic Formula
total bilirubin ≤ 1.5 × institution upper limit of normal (ULN) unless attributable to Gilbert's disease
AST and ALT ≤ 3 × institution ULN.
Negative antigen or PCR test for SARS-CoV-2. 9. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) and refrain from donating eggs or sperm throughout the treatment and for 3 months after the last dose of trial therapy.
active bacterial infection requiring antibiotics
chronic active Epstein Barr virus (CAEBV) infection
history of hemophagocytic lymphohistiocytosis (HLH)
history of Stevens-Johnson syndrome or toxic epidermal necrolysis
progressive multifocal leukoencephalopathy (PML)
known active EBV or CMV viremia
autoimmune disease requiring systemic immunosuppressive therapy
active myasthenia gravis, myositis, autoimmune hepatitis, idiopathic pulmonary fibrosis, systemic lupus erythematosus, inflammatory bowel disease, granulomatosis with polyangiitis, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
active hepatitis B (HBV) or hepatitis C (HCV) infection. Patients with a positive total/IgG HBV core antibody (HBcAb) are eligible if (1) HBV DNA is documented at screening, (2) they agree to take entecavir or tenofovir, and (3) they agree to undergo periodic DNA testing. Patients with a positive HCV antibody are eligible if a negative polymerase chain reaction (PCR) for HCV is documented.
HIV infection with a detectable viral load or a CD4 count \<200 cells/mm3. Patients (1) with an undetectable viral load and CD4 count \>200 cells/mm3 within 6 months prior to enrollment, and (2) on antiretroviral therapy are eligible. 10. Administration of a live, attenuated vaccine within 4 weeks before first treatment or anticipation that such a live, attenuated vaccine will be required during the study. 11. History of other malignancy that could affect compliance with the protocol or interpretation of the primary endpoint in the judgement of the investigator. 12. Any major surgery within 4 weeks before the first dose of treatment. 13. Evidence of other significant or uncontrolled medical or psychiatric conditions that could affect compliance with the protocol, in the judgement of the investigator.

What this trial measures

  • Complete response rate3 months after starting therapy

    • Complete response (CR) rate after 4 cycles of TPG therapy, evaluated by PET-CT using Lugano criteria

  • Rate of toxicitiesFrom the day when informed consent is obtained until 90 days following the last administration of study treatment.

    Occurrence and severity of adverse events will be examined throughout the treatment using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0, except cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) will be assessed using the American Society of Transplantation and Cellular Therapy (ASTCT) criteria