43 Participants Needed

Glofitamab + Chemotherapy for Non-Hodgkin's Lymphoma

Recruiting at 12 trial locations
RS
Overseen ByReference Study ID Number: GO43693 https://forpatients.roche.com/
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called glofitamab combined with other cancer drugs in patients with a type of lymphoma that hasn't responded to previous treatments. The treatment works by helping the immune system attack cancer cells and using chemotherapy to kill or stop the growth of these cells.

Do I need to stop my current medications to join the trial?

The trial requires that you stop certain cancer treatments, like chemotherapy and immunotherapy, at least 2 weeks before starting the study. If you're on monoclonal antibodies for cancer, you need to stop them 4 weeks before. If you're taking corticosteroids, you must be on a stable dose of 30 mg/day or less for at least 4 weeks before starting the trial.

What data supports the effectiveness of the drug combination Glofitamab + Chemotherapy for Non-Hodgkin's Lymphoma?

The combination of rituximab with chemotherapy has shown improved outcomes in various types of lymphomas, such as increased progression-free survival in mantle cell lymphoma and improved response rates in diffuse large B-cell lymphoma. Additionally, the ICE regimen (ifosfamide, carboplatin, and etoposide) has been effective for patients with relapsed or refractory non-Hodgkin's lymphoma.12345

What safety data exists for the combination of Glofitamab and chemotherapy drugs like Carboplatin, Ifosfamide, and Etoposide?

The combination of Carboplatin, Ifosfamide, and Etoposide has been studied in various trials, showing that the main safety concerns are myelosuppression (a decrease in bone marrow activity leading to fewer blood cells), including neutropenia (low white blood cell count) and thrombocytopenia (low platelet count). Other side effects include nausea, fatigue, and mild nerve damage, but these are generally manageable.678910

What makes the Glofitamab + Chemotherapy treatment unique for non-Hodgkin's lymphoma?

This treatment is unique because it combines glofitamab, a novel antibody targeting CD20 on B cells, with a chemotherapy regimen that includes carboplatin, etoposide, ifosfamide, and rituximab, which are known for their effectiveness in relapsed or refractory cases. The combination aims to enhance the immune system's ability to fight cancer cells while using chemotherapy to reduce tumor size.511121314

Research Team

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for people with a type of cancer called diffuse large B-cell lymphoma that has come back or didn't respond after their first treatment. They must have had therapy before that included an anti-CD20 antibody and anthracycline, be healthy enough to consider more intense treatments like stem cell transplant or CAR-T therapy, and not have certain medical conditions.

Inclusion Criteria

Life expectancy β‰₯ 12 weeks
I am eligible for intense chemotherapy followed by stem cell or CAR-T therapy.
My cancer is a type of B-cell lymphoma confirmed by lab tests.
See 3 more

Exclusion Criteria

I have had a stem cell transplant from a donor.
I am on a stable dose of corticosteroids not exceeding 30 mg/day for at least 4 weeks.
I have or had a brain-related condition like stroke or epilepsy.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 3 cycles of glofitamab, rituximab, ifosfamide, carboplatin, and etoposide (glofit-R-ICE)

9 weeks
3 cycles of 21 days each

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2.5 years

Treatment Details

Interventions

  • Carboplatin
  • Etoposide
  • Glofitamab
  • Ifosfamide
  • Rituximab
Trial OverviewResearchers are testing how well Glofitamab works when given with Rituximab plus Ifosfamide, Carboplatin, and Etoposide in patients whose cancer returned or resisted the first line of treatment. The study will look at the drug's effects on the body and its safety.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: R/R DLBCLExperimental Treatment7 Interventions
Participants will receive up to 3 21-day cycles of glofitamab, rituximab, ifosfamide, carboplatin, and etoposide (glofit-R-ICE).

Carboplatin is already approved in United States, European Union, Canada for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Paraplatin for:
  • Ovarian cancer
  • Testicular cancer
  • Lung cancer
  • Head and neck cancer
  • Brain cancer
πŸ‡ͺπŸ‡Ί
Approved in European Union as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
πŸ‡¨πŸ‡¦
Approved in Canada as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
  • Testicular cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

Salvage chemotherapy followed by high-dose therapy and autologous stem cell transplantation is the standard treatment for relapsed diffuse large B-cell lymphoma, but the addition of rituximab has improved outcomes after first-line treatment and relapses.
The CORAL trial found no significant difference in response rates between two salvage regimens (R-ICE and R-DHAP), and identified that factors like early relapse and certain genetic markers significantly affect survival, indicating that over 70% of patients may not benefit from standard salvage therapy.
Is there any role for transplantation in the rituximab era for diffuse large B-cell lymphoma?Gisselbrecht, C.[2022]
In a study of 91 people living with HIV and Burkitt lymphoma, adding rituximab to CODOX-M/IVAC chemotherapy did not increase severe treatment-related toxicities, indicating it is a safe option for this population.
The addition of rituximab significantly improved both overall survival (72% vs. 55%) and progression-free survival (81% vs. 55%) compared to chemotherapy alone, suggesting it enhances treatment efficacy without added risks.
Adding rituximab to CODOX-M/IVAC chemotherapy in the treatment of HIV-associated Burkitt lymphoma is safe when used with concurrent combination antiretroviral therapy.Alwan, F., He, A., Montoto, S., et al.[2022]
In a study involving 549 patients with advanced indolent lymphoma, bendamustine plus rituximab significantly improved median progression-free survival (69.5 months) compared to R-CHOP (31.2 months), indicating it may be a more effective first-line treatment.
Bendamustine plus rituximab was better tolerated than R-CHOP, with significantly lower rates of side effects such as alopecia, hematological toxicity, infections, and peripheral neuropathy, making it a safer option for patients.
Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial.Rummel, MJ., Niederle, N., Maschmeyer, G., et al.[2022]

References

The addition of rituximab to fludarabine and cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma: results of a randomized UK National Cancer Research Institute trial. [2018]
Is there any role for transplantation in the rituximab era for diffuse large B-cell lymphoma? [2022]
Adding rituximab to CODOX-M/IVAC chemotherapy in the treatment of HIV-associated Burkitt lymphoma is safe when used with concurrent combination antiretroviral therapy. [2022]
Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. [2022]
Ifosfamide, carboplatin, and etoposide: a highly effective cytoreduction and peripheral-blood progenitor-cell mobilization regimen for transplant-eligible patients with non-Hodgkin's lymphoma. [2017]
A phase I trial of AUC-directed carboplatin with infusional doxorubicin and ifosfamide plus G-CSF in patients with advanced gynecologic malignancies. [2013]
Dose-finding studies with carboplatin, ifosfamide, etoposide, and mesna in non-small cell lung cancer. [2018]
Phase I study of escalating targeted doses of carboplatin combined with ifosfamide and etoposide in treatment of newly diagnosed pediatric solid tumors. [2019]
Phase I trial of carboplatin, paclitaxel, etoposide, and cyclophosphamide with granulocyte colony stimulating factor as first-line therapy for patients with advanced epithelial ovarian cancer. [2015]
Paclitaxel and carboplatin in combination in the treatment of advanced non-small-cell lung cancer (NSCLC): a preliminary study. [2015]
11.United Statespubmed.ncbi.nlm.nih.gov
Use of rituximab, the new FDA-approved antibody. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Rituximab plus chemotherapy in follicular and mantle cell lymphomas. [2022]
IEVM chemotherapy with rhGM-CSF support for aggressive non-Hodgkin's lymphomas: a pilot study. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Phase II/III study of R-CHOP-21 versus R-CHOP-14 for untreated indolent B-cell non-Hodgkin's lymphoma: JCOG 0203 trial. [2022]