A clinical trial to look at the safety and effectiveness of three different combinations of drugs for treating follicular lymphoma, mosunetuzumab plus lenalidomide, glofitamab plus lenalidomide, or glofitamab plus obinutuzumab and lenalidomide, as well as the safety and tolerability of two different mosunetuzumab plus lenalidomide regimens

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma

  • Follicular Lymphoma
Trial Status:

Recruiting

This trial runs in
Cities
  • Barcelona
  • chang-chun-shi
  • chang-sha-shi
  • cheng-du-shi
  • Duarte
  • Lille
  • London
  • Madrid
  • Manchester
  • Montpellier
  • Málaga
  • Newcastle upon Tyne
  • Nottingham
  • Oxford
  • Paris
  • Pierre-Bénite
  • Rennes
  • Salamanca
  • Seattle
  • Shanghai
  • tian-jin-shi
  • Toulouse
Trial Identifier:

NCT04246086 2019-004291-20 CO41942

      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 evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab + lenalidomide in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT04246086 , CO41942 , 2019-004291-20 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      How does the CO41942 clinical trial work?

      This clinical trial is recruiting people who have a type of blood cancer called ‘follicular lymphoma’. In order to take part, patients must have ‘relapsed’ or ‘refractory’ follicular lymphoma, which means that the cancer has come back after being treated or did not get better with previous treatment.

      This clinical trial has two stages.

      In the first stage, researchers will test the safety and effectiveness of three different combinations of drugs: mosunetuzumab plus lenalidomide, glofitamab plus lenalidomide, and glofitamab plus obinutuzumab and lenalidomide. The first stage will also help researchers to understand the way your body processes these different combinations at different doses.

      In the second stage of the clinical trial, researchers will test how well two treatment regimens are tolerated: mosunetuzumab administered by an infusion into the vein plus lenalidomide, compared with mosunetuzumab administered by an injection under the skin plus lenalidomide. 

      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 follicular lymphoma, which has either not got better after previous treatment with chemo-immunotherapy, or has come back after you finished treatment. You must be at least 18 years old.

      Your cancer must not be ‘high-grade’ and it cannot have spread to the brain or spinal cord. If you have received certain previous treatments for your cancer you may not be able to take part. You must not have any other significant medical conditions, or be pregnant or breastfeeding.

      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?

      This clinical trial is open-label, which means that everyone involved will know which treatment they are receiving.

      In the first stage, patients will be put into one of three different treatment groups:

      • Mosunetuzumab plus lenalidomide
        • Mosunetuzumab given as an infusion into the vein on Day 1, Day 8 and Day 15 for the first 3 weeks (21 days), and then on Day 1 every 4 weeks (28 days) for a total of 12 rounds of treatment
        • Lenalidomide given as a tablet to take by mouth every day for 21 days, starting from Day 1 of the second round of treatment for a total of 12 rounds of treatment 
      • Glofitamab plus lenalidomide
        • Glofitamab given as an infusion into the vein on Day 8 and Day 15 for the first 3 weeks (21 days), and then on Day 1 every 4 weeks (28 days) for a total of 12 rounds of treatment
          • You will also receive one pretreatment with obinutuzumab, given as an infusion into the vein on Day 1 of the first round of treatment
        • Lenalidomide given as a tablet to take by mouth every day for 21 days, starting from Day 1 of the second round of treatment for a total of 12 rounds of treatment 
      • Glofitamab plus obinutuzumab and lenalidomide
        • Glofitamab given as an infusion into the vein on Day 8 and Day 15 for the first 3 weeks (21 days), and then on Day 1 every 4 weeks (28 days) for a total of 12 rounds of treatment
        • Obinutuzumab, given as an infusion into the vein on Day 1 of each round of treatment for a total of 12 rounds of treatment
        • Lenalidomide given as a tablet to take by mouth every day for 21 days, starting from Day 1 of the second round of treatment for a total of 12 rounds of treatment 

      People who have certain side effects may also receive a treatment called tocilizumab, given as an infusion into the vein.

      In the second stage, patients will be split into two groups randomly and given either:

      • Mosunetuzumab as an infusion into the vein plus lenalidomide
        • Mosunetuzumab given as an infusion into the vein on Day 1, Day 8 and Day 15 for the first 3 weeks (21 days), and then on Day 1 every 4 weeks (28 days) for a total of 12 rounds of treatment
        • Lenalidomide given as a tablet to take by mouth every day for 21 days, starting from Day 1 of the second round of treatment for a total of 12 rounds of treatment

      OR

      • Mosunetuzumab as an injection under the skin (subcutaneous), plus lenalidomide
        • Mosunetuzumab given as an injection under the skin on Day 1, Day 8 and Day 15 for the first 3 weeks (21 days), and then on Day 1 every 4 weeks (28 days) for a total of 12 rounds of treatment
        • Lenalidomide given as a tablet to take by mouth every day for 21 days, starting from Day 1 of the second round of treatment for a total of 12 rounds of treatment

      In this stage, patients will have a 1 in 3 chance of being given mosunetuzumab as an infusion into the vein and a 2 in 3 chance of being given mosunetuzumab as an injection under the skin. 

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

      Enrolment in the first stage of the clinical trial has now been completed.

      If you choose to join this clinical trial, you will join the second stage and will be given the clinical trial treatments for a total of 12 rounds of treatment (approximately 1 year). Throughout the treatment period, you will need to attend regular hospital visits, which will include checks to see how you are responding to the treatment and any side effects that you may be having. You are free to stop treatment at any time. After being given your last dose, you will be contacted by the clinical trial staff approximately every 6 months for 2 years, as long as you agree to it.

      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 may 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/NCT04246086

      Trial-identifier: NCT04246086

      Trial Summary

      This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab + lenalidomide in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT04246086 , CO41942 , 2019-004291-20 Trial Identifier
      Mosunetuzumab (IV), Tocilizumab, Lenalidomide, Mosunetuzumab (SC) Treatments
      Follicular Lymphoma Condition
      Official Title

      A Phase Ib/II, Open-Label, Multicenter Study With a Non-Randomized Stage Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab Plus Lenalidomide (+Len), and a Randomized Stage Evaluating the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Patients With Follicular 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
      • R/R FL after treatment with at least one prior chemo immunotherapy regimen that included an anti CD20 monoclonal antibody (MAb)
      • Previously untreated participants with FL must require systemic therapy assessed by investigator based on the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
      • Histologically documented FL of Grade 1, 2, or 3a, and that expresses CD20 at time of diagnosis as determined by the local laboratory
      • Fluorodeoxyglucose avid lymphoma (i.e., positron emission tomography (PET) positive lymphoma)
      • At least one bi dimensionally measurable nodal lesion (>1.5 cm in its largest dimension by PET- computed tomography (CT) scan), or at least one bi dimensionally measurable extranodal lesion (>1.0 cm in its largest dimension by PET-CT scan)
      • Availability of a representative tumor specimen and the corresponding pathology report for confirmation of the diagnosis of FL
      • Adequate hematologic function (unless due to underlying lymphoma, per the investigator) as defined by the protocol
      • Normal laboratory values (unless due to underlying lymphoma) as defined by the protocol
      • Agreement to comply with all local requirements of the Len risk minimization plan
      • For women of childbearing potential: agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period, and for at least 12 months after the final dose of glofitamab, 28 days after the last dose of Len, 18 months after the last dose of G, 3 months after the final dose of tocilizumab, and 3 months after the final dose of Mosun. Women must refrain from donating eggs during this same period
      • For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, with female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 2 months after the final dose of glofitamab, 28 days after last dose of Len, 18 months after the last dose of G, 3 months after the final dose of tocilizumab, and 3 months after the final dose of Mosun
      Exclusion Criteria
      • Any history of Grade 3b FL
      • Any history of transformation and/or diffuse large B-cell lymphoma (DLBCL)
      • Documented refractoriness to an obinutuzumab monotherapy containing regimen in glofitamab-containing treatment combination
      • Active or history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
      • Documented refractoriness to lenalidomide, defined as no response (partial response (PR) or complete response (CR)) within 6 months of therapy
      • Prior standard or investigational anti-cancer therapy as specified by the protocol
      • Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <=2 prior to Day 1 of Cycle 1
      • Known history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT scan
      • Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
      • History of solid organ transplantation
      • History of severe allergic or anaphylactic reaction to humanized, chimeric or murine MAbs
      • Known sensitivity or allergy to murine products
      • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the glofitamab, Mosun, G, Len, or thalidomide formulation, including mannitol
      • History of erythema multiforme, Grade >=3 rash, or blistering following prior treatment with immunomodulatory derivatives
      • Known history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis or evidence of active pneumonitis on screening chest CT scan
      • Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
      • Known or suspected chronic active Epstein-Barr virus infection or hemophagocytic syndrome
      • Known history of macrophage activating syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
      • Active Hepatitis B and Hepatitis C infection or autoimmune disease requiring treatment
      • Prior allogenic hematopoietic stem cell transplant
      • Known history of HIV positive status
      • History of progressive multifocal leukoencephalopathy
      • Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
      • Other malignancy that could affect compliance with the protocol or interpretation of results
      • Prior allogenic hematopoietic stem cell transplant (HSCT)
      • Contraindication to treatment for thromboembolism prophylaxis
      • Grade >=2 neuropathy
      • Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to significant cardiovascular disease or significant pulmonary disease
      • Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study
      • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
      • Inadequate hematologic function
      • Any of the following abnormal laboratory values
      • Pregnant or lactating or intending to become pregnant during the study
      • Life expectancy < 3 months
      • Unable to comply with the study protocol, in the investigator's judgment
      • History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
      • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or Medical Monitor's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

      About Clinical Research

      What is a clinical trial? Why should I consider taking part in a clinical trial? And why does Genentech conduct clinical trials?

      Find out now