Tafasitamab + Polatuzumab Vedotin + Glofitamab for Diffuse Large B-Cell Lymphoma
(TPG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of three drugs to treat diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The goal is to evaluate the effectiveness of this combination as a first-line treatment. It is open to individuals diagnosed with DLBCL or HGBL who have received minimal prior treatment for their lymphoma. Those experiencing symptoms and requiring immediate treatment might be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot use systemic immunosuppressive medications within 2 weeks before starting the study treatment, unless they are allowed for managing lymphoma.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of tafasitamab, polatuzumab vedotin, and glofitamab is generally safe for patients with certain types of lymphoma. Specifically, studies found that using glofitamab with polatuzumab vedotin remained safe even for patients with extensive prior treatments. While some side effects occurred, they were usually not serious enough to outweigh the potential benefits.
Additionally, tafasitamab has received approval for use with other drugs for similar conditions, indicating it is generally well-tolerated. However, more than half of the patients in some studies experienced side effects that were moderate to severe.
These findings suggest that while the combination treatment is generally safe, participants should remain aware of possible side effects and discuss them with their healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Tafasitamab, Polatuzumab Vedotin, and Glofitamab for treating Diffuse Large B-Cell Lymphoma because each component offers a unique mechanism of action. Tafasitamab is an antibody that targets CD19 on B-cells, enhancing the immune response against cancer cells. Polatuzumab Vedotin delivers a potent chemotherapy agent directly to B-cells by targeting CD79b, minimizing damage to healthy cells. Glofitamab is a bispecific antibody that connects T-cells to cancer cells, boosting the body’s ability to attack tumors. This combination could offer a more targeted and potentially more effective alternative to existing treatments like R-CHOP, which primarily rely on broad cytotoxic chemotherapy.
What evidence suggests that this trial's treatments could be effective for diffuse large B-cell lymphoma?
Research has shown that combining the drugs glofitamab and polatuzumab vedotin holds promise for treating certain types of lymphoma. Studies have found that this combination can lead to high response rates and long-lasting remissions, even in patients who have tried multiple treatments before. For example, one study reported an overall response rate of 59%. Tafasitamab, another drug included in the TPG therapy under study in this trial, targets specific cancer cells, potentially improving treatment effectiveness. While the exact effectiveness of using all three drugs together is still under investigation in this trial, each drug has demonstrated strong results in treating similar conditions. These findings suggest that this combination could offer a powerful new option for patients with diffuse large B-cell lymphoma.25678
Who Is on the Research Team?
Adam Olszewski
Principal Investigator
Brown University Health
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) with certain types of aggressive B-cell lymphomas, including diffuse large B-cell lymphoma and high-grade B-cell lymphoma. Participants must be able to give informed consent and follow study procedures.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TPG therapy for the first four 21-day cycles, followed by response-adapted therapy based on PET-CT assessment
Response Assessment
Primary endpoint evaluation using PET-CT based Lugano criteria to determine subsequent therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Glofitamab
- Polatuzumab Vedotin
- Tafasitamab
Trial Overview
The study is testing a new combination of three drugs—tafasitamab, polatuzumab vedotin, and glofitamab—as the first treatment for these lymphomas. All participants receive this drug combo in an open-label phase 2 trial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brown University
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
Natera, Inc.
Industry Sponsor
Citations
Efficacy and Safety of Glofitamab Plus Polatuzumab ...
Glofitamab and polatuzumab vedotin are novel treatments with promising antilymphoma activity when delivered in combination (Glofit-Pola). This ...
Efficacy and Safety of Glofitamab Plus Polatuzumab ...
Glofit-Pola demonstrated high efficacy and durable responses, with manageable safety, in heavily pretreated patients with R/R LBCL, ...
Tafasitamab + Polatuzumab Vedotin + Glofitamab for ...
This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) ...
4.
hematologyadvisor.com
hematologyadvisor.com/news/lymphoma-lbcl-glofitamab-polatuzumab-vedotin-therapy-treatment-risk/Combination Glofitamab and Polatuzumab Vedotin ...
It has an overall response rate of 59.0%, the study authors noted. Polatuzumab vedotin has also shown efficacy when administered in conjunction ...
5.
ashpublications.org
ashpublications.org/blood/article/146/18/2177/546196/Real-world-outcomes-of-patients-with-aggressive-BReal-world outcomes of patients with aggressive B-cell ...
Key PointsBispecifics had an ORR and CR rate of 51.7% and 25.4%, respectively; median PFS and OS were 2.5 and 7.8 months, respectively.
761163Orig1s000 - accessdata.fda.gov
Based on the efficacy and safety information currently available, the clinical reviewer recommends approval of tafasitamab-cxix in combination ...
Tafasitamab for the treatment of patients with diffuse large B ...
This study reported outcomes for three pre-specified treatments not assessed in the RE-MIND study which included treatment with polatuzumab vedotin in ...
8.
ashpublications.org
ashpublications.org/bloodadvances/article/9/15/3865/534578/Safety-and-efficacy-of-glofitamab-for-relapsedSafety and efficacy of glofitamab for relapsed/refractory large ...
Glofitamab has a 46% ORR (27% CR; 19% PR) and a manageable safety in heavily pretreated patients with r/r LBCL. Increased lactate dehydrogenase is the ...
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