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Diffuse Large B Cell LymphomaPhase 2TPGNCT07502872

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

A Phase 2 study testing Tafasitamab, Polatuzumab vedotin and Glofitamab in people with Diffuse Large B Cell Lymphoma and High-grade B-cell Lymphoma, run by Brown University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) as first-line treatment of patients with diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tafasitamab, Polatuzumab vedotin and Glofitamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Nov 2026to 1 Jan 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures.
  • Age ≥18 years.
  • 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
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  • 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.
  • FDG-avid disease by PET-CT Lugano criteria.
  • 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.
  • Performance status ECOG 0, 1, or 2.
  • Ability to receive one of the standard chemotherapy regimens for DLBCL/HGBL including attenuated versions, where clinically appropriate
  • 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.
  • 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.

Who cannot join

  • Pregnancy, breast-feeding, or prisoner status.
  • Central nervous system involvement by the lymphoma.
  • Prior solid organ transplantation or allogeneic stem cell transplantation.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
  • Known NYHA class 3/4 congestive heart failure, left ventricular ejection fraction (LVEF) <30%, or active ischemic heart disease.
  • Chronic obstructive pulmonary disease (COPD) requiring continuous oral corticosteroids or chronic oxygen.
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  • Grade >1 peripheral neuropathy.
  • 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).
  • 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.
  • 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.
  • History of other malignancy that could affect compliance with the protocol or interpretation of the primary endpoint in the judgement of the investigator.
  • Any major surgery within 4 weeks before the first dose of treatment.
  • Evidence of other significant or uncontrolled medical or psychiatric conditions that could affect compliance with the protocol, in the judgement of the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Roxanne Wood contact

(401) 863-3000

BrUOG@brown.edu

United States1 site

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Roxanne Wood, 1-844-222-2881, BrUOG@brown.edu

    Adam Olszewski, MD

Other trials in United States

About this study

Official title: TPG: a Phase 2 Trial of Polatuzumab Vedotin, Glofitamab, and Tafasitamab as Chemotherapy-sparing First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) as first-line treatment of patients with diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL).

Being tested
Tafasitamab, Polatuzumab vedotin, Glofitamab, Obinutuzumab
Keywords
glofitamab, polatuzumab vedotin, tafasitamab, immunotherapy
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TafasitamabDrug

    Also called Monjuvi

    Cytolytic monoclonal antibody targeting CD19.

  • Polatuzumab vedotinDrug

    Also called Polivy

    CD79b-targeting antibody-drug conjugate

  • GlofitamabDrug

    Also called Columvi

    CD20xCD3 bispecific antibody

  • ObinutuzumabDrug

    Also called Gazyva

    Anti-CD20 monoclonal antibody

Study groups in NCT07502872
Study groupRoleWhat they receive
TPG therapyExperimentalAll enrolled patients will receive the same study therapy for the first four 21-day cycles, followed by the primary endpoint evaluation, and subsequent response-adapted therapy. After 4 cycles, the primary endpoint will be assessed by using positron emission tomography/computed tomography (PET-CT) based Lugano criteria. Subsequent therapy will be determined at that time, guided by the response assessment. Patients in complete response or with a partial metabolic response and a negative minimal residual disease (MRD) assay will continue with subsequent cycles of TPG immunotherapy. Patients who do not achieve these criteria will transition to standard immunochemotherapy, which will be delivered according to institutional standards.
Receives: Drug: Tafasitamab; Drug: Polatuzumab vedotin; Drug: Glofitamab; Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate

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

    Measured: 3 months after starting therapy

  2. Rate of toxicities

    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

    Measured: From the day when informed consent is obtained until 90 days following the last administration of study treatment.

Secondary outcomes (8)

  1. Progression-free survival

    PFS will be determined according to the guidance from the International Working Group

    Measured: PFS will be measured from the day of the registration on study until the end of follow up, for up to 5 years

  2. Event-free survival

    EFS will be determined using the following events: disease progression, disease recurrence, a switch from TPG to standard chemotherapy (or alternative therapy), initiation of any new therapy for lymphoma after attaining a CR, or death from any cause.

    Measured: EFS will be measured from the day of the registration on study until the end of follow up, for up to 5 years

  3. Overall survival

    OS will be determined using death from any cause and measured from registration until the end of follow up.

    Measured: OS will be measured from the day of the registration on study until the end of follow up, for up to 5 years

  4. Duration of response

    assessed only for patients who achieve an overall response

    Measured: Duration of response will be measured from the day of the first response recored on study until the end of follow up, for up to 5 years

  5. Duration of complete response

    assessed only for patients who achieve a complete response

    Measured: Duration of complete response will be measured from the first response assessment showing a complete response until the end of follow up, up to 5 years.

  6. Health-related quality of life

    HR-QOL will be measured using FACT-Lym instrument. FACT-Lym has a score range of 0 to 88 and the higher scores indicate worse HR-QOL

    Measured: At timepoints specified in the protocol: at baseline, after Cycle 4 (cycle length is 21 days), at the end of therapy visit (typically 9 months from the start).

  7. Patient-centered measure of treatment burden

    Measured using the PRIMIS-APSRA instrument. The instrument has a score range 8 to 40 and higher scores indicate better functional status.

    Measured: At timepoints specified in the protocol: at baseline, after Cycle 4 (cycle length is 21 days), at the end of therapy visit (typically 9 months from the start of therapy).

  8. Minimal residual disease

    using a ctDNA assay performed at protocol-specified timepoints

    Measured: At timepoints specified in the protocol: at baseline, after Cycle 4 (cycle length is 21 days), at the end of therapy (typically 9 months from the start), then every 6 months until 2 years of follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Jan 2030 (estimated)
  4. Study completion1 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07502872
Sponsor's protocol ID
BrUOG-450
Other IDs
ML46671, I-000585-25-02
Acronym
TPG
Status last verified
Aug 2026
First submitted
14 Mar 2026
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: IPD are protected by applicable US laws. Summary data can be provided by the principal investigator to qualified researchers with adequate human subject protection committee approval and data use agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tafasitamab, Polatuzumab vedotin and Glofitamab in people with Diffuse Large B Cell Lymphoma and High-grade B-cell Lymphoma, run by Brown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roxanne Wood ((401) 863-3000, BrUOG@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: 3 months after starting therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07502872.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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