New drug cocktail aims to replace chemo for lymphoma patients
NCT ID NCT07502872
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This phase 2 trial is testing a combination of three drugs (polatuzumab vedotin, glofitamab, and tafasitamab) as a first-line treatment for people with diffuse large B-cell lymphoma or high-grade B-cell lymphoma. The goal is to see if this chemo-free approach can shrink tumors and control the disease with fewer side effects. About 30 participants will receive the treatment, and researchers will monitor how many achieve a complete response and what side effects occur.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Polatuzumab vedotin, glofitamab, and tafasitamab (drug combination)
- What this could lead to
- If successful, this could offer a chemotherapy-free first-line treatment option for certain types of B-cell lymphoma, potentially reducing side effects while controlling the disease.
- What could go wrong
- This is a small, early-phase (phase 2) trial with only 30 participants, so results may not apply broadly. The combination may cause serious side effects like cytokine release syndrome, and it is not expected to cure the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures. 2. Age ≥18 years. 3. Histologically confirmed diagnosis of DLBCL, or HGBL, according to 5th edition WHO classification. Eligible WHO entities include: * 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. Exclusion Criteria: 1. Pregnancy, breast-feeding, or prisoner status. 2. Central nervous system involvement by the lymphoma. 3. Prior solid organ transplantation or allogeneic stem cell transplantation. 4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products. 5. Known NYHA class 3/4 congestive heart failure, left ventricular ejection fraction (LVEF) \<30%, or active ischemic heart disease. 6. Chronic obstructive pulmonary disease (COPD) requiring continuous oral corticosteroids or chronic oxygen. 7. Grade \>1 peripheral neuropathy. 8. Use of systemic immunosuppressive medications (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 2 weeks prior to first dose of study treatment (except as allowed in the inclusion criteria for the management of lymphoma). 9. Any of the following conditions: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rhode Island Hospital
Providence, Rhode Island, 02903, United States
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