41 Participants Needed

Glofitamab + Polatuzumab-R-CHP for Diffuse Large B-Cell Lymphoma

Recruiting at 3 trial locations
PA
MF
Jennifer Crombie, MD profile photo
Overseen ByJennifer Crombie, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of drugs to treat high-risk diffuse large B-cell lymphoma in patients who have not been treated before. The drugs help the immune system attack cancer and directly kill cancer cells. The standard treatment for diffuse large B-cell lymphoma (DLBCL) includes rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that prior use of certain treatments, like monoclonal antibodies or cytotoxic drugs, may affect eligibility. It's best to discuss your current medications with the trial team to get a clear answer.

Is the combination of Glofitamab and Polatuzumab-R-CHP safe for humans?

Polatuzumab vedotin, when used in combination with other drugs for treating diffuse large B-cell lymphoma, has shown an acceptable safety profile in clinical trials. Common side effects include blood-related issues like anemia (low red blood cell count) and neutropenia (low white blood cell count), but no fatal adverse events were observed.12345

What makes the drug combination of Glofitamab, Polatuzumab, and R-CHP unique for treating diffuse large B-cell lymphoma?

This drug combination is unique because it includes polatuzumab vedotin, an antibody-drug conjugate that targets CD79b on B-cells and delivers a toxin to kill cancer cells, and is combined with glofitamab, a novel bispecific antibody, and R-CHP chemotherapy, offering a new approach for patients with relapsed or refractory diffuse large B-cell lymphoma who have limited treatment options.23467

What data supports the effectiveness of the drug combination Glofitamab + Polatuzumab-R-CHP for treating Diffuse Large B-Cell Lymphoma?

Research shows that polatuzumab vedotin, part of the treatment, has demonstrated significant clinical efficacy in relapsed or refractory diffuse large B-cell lymphoma, leading to its FDA approval in combination with other drugs. Additionally, glofitamab, another component, has been studied for its survival outcomes in similar conditions, although it did not show a clear advantage over other treatments.24789

Who Is on the Research Team?

Jennifer Crombie, MD - Dana-Farber ...

Jennifer Crombie, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with untreated high-risk diffuse large B-cell lymphoma (DLBCL), a type of cancer. They must have an IPI score of 2-5, be in decent physical shape (ECOG 0-1-2), and their heart and other organs must work well. Women who can have babies and men must agree to use birth control. People with prior organ transplants, recent cancer treatments, or certain infections like HIV can't join.

Inclusion Criteria

I have a lymphoma lesion that shows up on scans.
I have chronic hepatitis B with no detectable virus in my blood.
Women of childbearing potential must use effective contraception
See 9 more

Exclusion Criteria

I have tested positive for HIV or HTLV-1.
I am not allergic to the drugs used in this study.
I have not had an active infection or a flare-up of a hidden infection in the last 2 weeks.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two cycles of polatuzumab-R-CHP and four cycles of glofitamab-polatuzumab-R-CHP, followed by two additional cycles of glofitamab alone

24 weeks
8 cycles of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Glofitamab
  • Polatuzumab
  • R-CHP
Trial Overview The study tests Glofitamab combined with Polatuzumab alongside standard chemo R-CHP (Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Prednisone) for treating DLBCL. Glofitamab is a T-cell bispecific antibody; Polatuzumab is an antibody-drug conjugate; R-CHP are established chemotherapy drugs.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Polatuzumab + Glofitamab + R-CHExperimental Treatment6 Interventions

Glofitamab is already approved in United States for the following indications:

🇺🇸
Approved in United States as COLUMVI for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Philippe Armand, MD, PhD

Lead Sponsor

Trials
1
Recruited
40+

Jennifer Crombie, MD

Lead Sponsor

Trials
2
Recruited
80+

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Published Research Related to This Trial

In a study of patients with transplantation-ineligible relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), the combination of polatuzumab vedotin with bendamustine and rituximab (pola-BR) resulted in a significantly higher complete response (CR) rate of 40% compared to 17.5% with bendamustine and rituximab alone, indicating improved efficacy.
Patients receiving pola-BR also experienced longer progression-free survival (9.5 months vs. 3.7 months) and overall survival (12.4 months vs. 4.7 months), although there were higher rates of certain side effects like neutropenia and peripheral neuropathy, which were mostly manageable.
Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma.Sehn, LH., Herrera, AF., Flowers, CR., et al.[2021]
In a study involving 85 patients with untreated diffuse large B-cell lymphoma, the combination of polatuzumab vedotin with standard chemotherapy (R-CHP or G-CHP) showed promising preliminary efficacy, with 89% of patients achieving an overall response and 77% achieving a complete response.
The safety profile of polatuzumab vedotin was manageable, with common adverse events including neutropenia and peripheral neuropathy, leading to the establishment of a recommended phase 2 dose of 1.8 mg/kg for further investigation.
Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b-2 study.Tilly, H., Morschhauser, F., Bartlett, NL., et al.[2023]
Polatuzumab vedotin, an antibody-drug conjugate targeting CD79b, has shown significant clinical efficacy in treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and received accelerated FDA approval for use in patients who have failed at least two prior therapies.
The drug is currently being evaluated in combination with other therapies for previously untreated DLBCL patients, indicating its potential to play a broader role in the treatment of this heterogeneous disease.
Polatuzumab Vedotin: Current Role and Future Applications in the Treatment of Patients with Diffuse Large B-Cell Lymphoma.Assi, R., Masri, N., Dalle, IA., et al.[2021]

Citations

Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. [2021]
Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b-2 study. [2023]
Polatuzumab Vedotin: Current Role and Future Applications in the Treatment of Patients with Diffuse Large B-Cell Lymphoma. [2021]
Treatments for Relapsed-Refractory Diffuse Large B-cell Lymphoma: A Preliminary Evaluation of the Place in Therapy of Glofitamab, a Bispecific Monoclonal Antibody. [2023]
Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-Hodgkin lymphoma: final results from a phase 2 randomised study (ROMULUS). [2019]
Polatuzumab Vedotin: First Global Approval. [2023]
Polatuzumab vedotin in relapsed / refractory aggressive B-cell lymphoma. [2022]
A phase 2 study of polatuzumab vedotin + bendamustine + rituximab in relapsed/refractory diffuse large B-cell lymphoma. [2021]
Polatuzumab vedotin to treat relapsed or refractory diffuse large B-cell lymphoma, in combination with bendamustine plus rituximab. [2021]
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