A clinical trial to compare mosunetuzumab plus polatuzumab vedotin with rituximab plus gemcitabine plus oxaliplatin in people with relapsed or refractory aggressive non-Hodgkin’s lymphoma

A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

  • Diffuse Large B-Cell Lymphoma
Trial Status:

Recruiting

This trial runs in
Countries
  • Argentina
  • Israel
  • Mexico
  • New Zealand
  • Peru
  • Russia
  • South Korea
  • Thailand
  • Turkey
Trial Identifier:

NCT05171647 GO43643

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT05171647 , GO43643 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      How does the SUNMO clinical trial work?

      This clinical trial is recruiting people who have aggressive non-Hodgkin’s lymphoma (NHL), according to specific criteria. In order to take part, patients must have disease that has returned after successful treatment (relapsed) or that has not responded to treatment (refractory).

      The purpose of this clinical trial is to compare the effects, good or bad, of mosunetuzumab plus polatuzumab vedotin (called ‘M+P’ in this document) versus rituximab plus gemcitabine plus oxaliplatin (called ‘R-GemOx’ in this document) on patients with aggressive NHL. In this clinical trial, you will get either M+P or R-GemOx.

      How do I take part in this clinical trial?

      To be able to take part in this clinical trial, you must be at least 18 years old and have been diagnosed with aggressive NHL, according to specific criteria. You must have received at least one previous treatment for NHL, after which the cancer did not get better or came back.

      If you have certain other medical conditions or have received certain medications or treatments, you may not be able to take part in this clinical trial. If you are pregnant or breastfeeding, or are intending to become pregnant shortly after your last dose of clinical trial treatment, you will not be able to take part in this clinical trial.

      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.

      While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons. 

      What treatment will I be given if I join this clinical trial?

      Everyone who joins this clinical trial will be split into two groups randomly (like tossing a coin) and given either:

      • M+P treatment: mosunetuzumab, as an injection under the skin (subcutaneous) once a week for the first three weeks (Cycle 1), then once every three weeks for Cycles 2-8. You will also be given polatuzumab vedotin as an infusion into the vein once every three weeks for Cycles 1-6

      OR

      • R-GemOx treatment: rituximab, gemcitabine and oxaliplatin, each given as infusions into the vein every two weeks for up to eight cycles.

      You will have a 2 in 3 chance (67%) of being placed in the M+P group and a 1 in 3 chance (33%) of being placed in the R-GemOx group.

      How often will I be seen in follow-up appointments and for how long?

      You will be given the clinical trial treatments for up to 24 weeks (roughly six months) in the M+P group or for up to 16 weeks (roughly four months) in the R-GemOx group. You will also have some additional tests and procedures, such as blood tests, for research purposes. You are free to stop this treatment at any time. After you have finished your treatment, you will still be seen regularly by the clinical trial doctor every three months for up to two and a half years (from when you started clinical trial treatment). These hospital visits will include checks to see how you have responded to the treatment and checks on 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/NCT05171647

      Trial-identifier: NCT05171647

      Trial Summary

      This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT05171647 , GO43643 Trial Identifier
      Mosunetuzumab, Polatuzumab vedotin, Tocilizumab, Rituximab, Gemcitabine, Oxaliplatin Treatments
      Non-Hodgkin Lymphoma Condition
      Official Title

      A Randomized, Open-Label, Multicenter Phase III Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin in Comparison With Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
      • Life expectancy of at least 12 weeks
      • CD20+ aggressive lymphoma as determined by the local hemopathology laboratory from the following diagnoses by 2016 World Health Organization classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS); high-grade B-cell lymphoma (NOS or double/triple hit); trFL R/R to standard therapies to trFL; FL3B
      • Received at least one prior systemic therapy for aggressive non-Hodgkin's lymphoma (aNHL)
      • Have either relapsed or have become refractory to a prior regimen must meet the following criteria: relapsed to prior regimen(s) after having a documented history of response (CR or PR) of at least 6 months in duration from completion of regimen(s); refractory to any prior regimen, defined as no response to the prior therapy, or progression within 6 months of completion of the last dose of therapy
      • Participants who have received only one prior line of therapy must be ineligible for autologous stem cell transplant (ASCT)
      • Measurable disease, defined as at least 1 bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least 1 bi-dimensionally measurable extra nodal lesion, defined as > 1.0 cm in its longest dimension
      • Have a pathology report for the initial histopathology diagnosis and the most recent histopathology diagnosis prior to entering the study
      • Representative tumor specimen and the corresponding pathology report available for confirmation of diagnosis as well as for biomarker analysis
      • Adequate hepatic, hematologic, and renal function
      Exclusion Criteria
      • Pregnant or breast feeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab, 9 months after the final dose of polatuzumab vedotin, 12 months after the final dose of rituximab, 6 months after the final dose of gemcitabine, 9 months after the final dose of oxaliplatin, and 3 months after the final dose of tocilizumab, as applicable
      • Inability to comply with protocol-mandated activity restrictions
      • Prior treatment with mosunetuzumab or other CD-20-directed bispecific antibodies, polatuzumab vedotin, or R-GemOx or Gem-Ox
      • Contraindication to any component of the study treatment
      • Grade > 1 peripheral neuropathy
      • Received anti-lymphoma treatments with monoclonal antibodies, radio-immunoconjugates or antibody-drug conjugates (ADCs) within 4 weeks before the first dose of study treatment
      • Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of study treatment
      • Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
      • ASCT within 100 days prior to the first study treatment administration
      • Prior treatment with chimeric antigen receptor (CAR) T cell therapy within 30 days before the first study treatment administration
      • Prior allogenic stem cell transplant (SCT)
      • Have had a solid organ transplantation
      • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
      • History of confirmed progressive multifocal leukoencephalopathy
      • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombination antibody-related fusion proteins)
      • History of malignancy that has been treated with curative intent within >/= 2 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.. 5-year overall survival rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage 1 uterine cancer
      • Currently have or have had a past history of central nervous system (CNS) involvement of lymphoma
      • History of CNS disease which was symptomatic or required treatment in the past 1 year, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
      • Significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina
      • Significant active pulmonary disease
      • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of the nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to the first study treatment administration
      • Known or suspected chronic active Epstein-Barr virus (EBV) infection
      • Recent major surgery within 4 weeks prior to the first study treatment administration
      • Positive test results for chronic hepatitis B infection
      • Acute or chronic hepatitis C virus (HCV) infection
      • History of HIV infection
      • Have been administered a live, attenuated vaccine within 4 weeks before the first dose of study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
      • History of autoimmune disease
      • Received systemic immunosuppressive medications (including, but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) with the exception of corticosteroid treatment </= 10 mg/day prednisone or equivalent within 2 weeks prior to first dose of study treatment
      • Received investigational therapy, whether or not intended for lymphoma treatment, within 7 days prior to initiation of study treatment
      • Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
      • Any serious medical condition or abnormality in clinical laboratory tests that precludes the participant's safe participation in and in the completion of the study, or which could affect compliance with the protocol or interpretation of results

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