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A clinical trial to compare glofitamab plus chemotherapy with rituximab plus chemotherapy in people with diffuse large B-cell lymphoma (after previous treatment has not worked).
A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Cancer
- Non Hodgkin Lymphoma (NHL)
- Diffuse Large B-Cell Lymphoma (DLBCL)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Active, not recruiting
This trial runs in
Countries
- Australia
- Belgium
- China
- Denmark
- France
- Germany
- Poland
- Puerto Rico
- South Korea
- Spain
- Switzerland
- Taiwan
- United Kingdom
- United States
Trial Identifier:
NCT04408638 2020-001021-31 GO41944
Trial Summary
This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04408638, GO41944, 2020-001021-31
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
How does the GO41944 clinical trial work?
This clinical trial is recruiting people who have a type of disease called diffuse large B-cell lymphoma, or DLBCL. In order to take part, patients must have DLBCL that is relapsed or refractory.
The purpose of this clinical trial is to compare the effects, good or bad, of glofitamab plus chemotherapy versus rituximab plus chemotherapy on patients with relapsed or refractory DLBCL.
In this clinical trial, you will get either glofitamab plus two chemotherapy drugs (gemcitabine and oxaliplatin, often shortened to GemOx) or rituximab plus GemOx.
How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must have been diagnosed with DLBCL that has not improved within 6 months of completing your last treatment (refractory), or has come back after a minimum of 6 months from completing your last treatment (relapsed). If you have only received one previous course of treatment, your doctor must also make sure that you are not a candidate for bone marrow transplant.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
If you or your partner are able to become pregnant, your doctor will talk to you about requirements for contraception (or alternatively abstaining from sexual intercourse) during the clinical trial.
What treatment will I be given if I join this clinical trial?
The treatments in this clinical trial will be given in ‘cycles’, with each cycle lasting for 3 weeks (21 days). Everyone who joins this clinical trial will be split into 2 groups randomly (like flipping a coin).
Patients in the glofitamab plus GemOx group will receive:
- Obinutuzumab (pretreatment to reduce the side effects of glofitamab) given as an infusion into the vein on Day 1 of cycle 1
- Gemcitabine and oxaliplatin given as an infusion into the vein on Day 2 of cycle 1 and then on Day 1 or Day 2 of subsequent cycles, for up to 8 cycles in total
- Glofitamab, given as an infusion into the vein on Day 8 and Day 15 of cycle 1, and then on Day 1 of each of the next 11 cycles
Patients in the rituximab plus GemOx group will receive:
- Rituximab, given as an infusion into the vein on Day 1 of each cycle for up to 8 cycles
- Gemcitabine and oxaliplatin on Day 2 of cycle 1 and then on Day 1 or Day 2 of subsequent cycles, for up to 8 cycles in total
You will have a 2 in 3 chance of being entered into the glofitamab plus GemOx group, and a 1 in 3 chance of being entered into the rituximab plus GemOx group.
How often will I be seen in follow-up appointment and for how long?
You will be given the clinical trial treatment glofitamab for up to 12 cycles or rituximab for up to 8 cycles, plus up to 8 cycles of GemOx chemotherapy. You are free to stop this treatment at any time. After being given treatment, you will still be seen regularly by the clinical trial doctor every 3 months. These hospital visits will include checks to see how you are responding to the treatment and any side effects that you may be having.
What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT04408638
Trial-identifier: NCT04408638
Trial Summary
This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04408638, GO41944, 2020-001021-31
Trial Identifier
Obinutuzumab, Glofitamab, Rituxumab, Tocilizumab, Gemcitabine, Oxaliplatin
Treatments
Diffuse Large B-cell Lymphoma
Condition
Official Title
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL), not otherwise specified
- Relapsed/refractory (R/R) disease, defined as follows: Relapsed = disease that has recurred ≥6 months after completion of the last line of therapy; Refractory = disease that either progressed during the last line of therapy or progressed within 6 months (<6 months) of the last line of prior therapy
- At least one (≥1) line of prior systemic therapy
- Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant, as defined by the study protocol
- Confirmed availability of tumor tissue, unless unobtainable per investigator assessment. Freshly collected biopsy is preferred. Archival tissue is acceptable
- At least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on computed tomography (CT) scan
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Adequate hematologic function (unless attributable to the underlying disease, as established by extensive bone marrow involvement or associated with hypersplenism secondary to the involvement of the spleen by DLBCL per the investigator), as defined by the study protocol
- Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment
- Adequate renal function, defined as an estimated creatinine clearance ≥30 mL/min
Exclusion Criteria
- Patient has failed only one prior line of therapy and is a candidate for stem cell transplantation
- History of transformation of indolent disease to DLBCL
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma not otherwise specified, as defined by 2016 WHO guidelines
- Primary mediastinal B-cell lymphoma
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- Contraindication to obinutuzumab, rituximab, gemcitabine or oxaliplatin, or tocilizumab
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
- Peripheral neuropathy assessed to be Grade >1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment
- Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
- Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
- Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
- Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment
- Positive SARS-CoV-2 infection within 30 days prior to the first study treatment, including asymptomatic SARS-CoV-2 infection
- Documented SARS-CoV-2 infection within 6 months of first study treatment
- Suspected or latent tuberculosis
- Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Known or suspected chronic active Epstein-Barr viral infection
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- Known history of progressive multifocal leukoencephalopathy
- Adverse events from prior anti-cancer therapy not resolved to Grade 1 or better (with the exception of alopecia and anorexia)
- Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
- Prior solid organ transplantation
- Prior allogeneic stem cell transplant
- Active autoimmune disease requiring treatment
- Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 4 weeks prior to first dose of study treatment
- Corticosteroid therapy within 2 weeks prior to first dose of study treatment (exceptions defined by study protocol)
- Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
- Clinically significant history of cirrhotic liver disease
For the latest version of this information please go to www.forpatients.roche.com