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A clinical trial to compare the drug combination mosunetuzumab plus lenalidomide with the drug combination rituximab plus lenalidomide in people with previously treated follicular lymphoma
A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy
- Relapsed or Refractory Follicular Lymphoma
Trial Status:
Recruiting
This trial runs in
Cities
- Adelaide
- Ankara
- Ann Arbor
- Bamberg
- Bayonne
- bei-jing-shi
- Berlin
- Boivre-la-Vallée
- Bologna
- Camden
- Chambéry
- Chuo City
- Créteil
- Dresden
- Duarte
- Fort Wayne
- gaziantep
- Gdynia
- Geelong
- Houston
- İstanbul
- Kashiwa
- Katowice
- Kennewick
- Lille
- Marseille
- Montpellier
- Moscow
- München
- nan-jing-shi
- Nantes
- New Taipei City
- New York
- Nice
- Nottingham
- Olsztyn
- Paraná
- Pessac
- Porto Alegre
- Poznań
- Regensburg
- Reims
- Rennes
- Rio Grande do Sul
- Sendai
- Seongnam-si
- Seoul
- St Priest En Jarez
- St. Louis
- Strasbourg
- Taipei City
- tian-jin-shi
- València
- Wrocław
- wu-han-shi
- Xiamen
- zheng-zhou-shi
Trial Identifier:
NCT04712097 2020-005239-53 GO42909
Trial Summary
This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy. Download brochure
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04712097 , GO42909 , 2020-005239-53
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
How does the GO42909 clinical trial work?
This clinical trial is recruiting people who have a specific type of blood cancer called follicular lymphoma. Patients must have relapsed (the cancer came back after previous treatment) or refractory (the cancer did not get better with previous treatment) follicular lymphoma.
The purpose of this clinical trial is to compare the effects, good or bad, of mosunetuzumab plus lenalidomide with rituximab plus lenalidomide in patients with follicular lymphoma. In this clinical trial, you will get either the mosunetuzumab plus lenalidomide combination or the rituximab plus lenalidomide combination.
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 and be at least 18 years old. You must have already received at least one prior systemic treatment (a treatment that travels through your bloodstream) for your disease.
You will not be able to take part in this clinical trial if you are pregnant, breastfeeding or intending to become pregnant during the clinical trial. You may also not be able to take part in the clinical trial if you have certain other medical conditions or if you have previously received certain medications.
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 measures 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 flipping a coin) and given either:
- Mosunetuzumab plus lenalidomide
- Mosunetuzumab given as an infusion into the vein on Days 1, 8 and 15 for the first 21 days (Cycle 1), and then on Day 1 every 28 days (Cycles 2–12)
- Lenalidomide given as a pill once a day for the first 21 days of every 28-day cycle, starting from Day 1 of Cycle 2
- OR rituximab plus lenalidomide
- Rituximab given as an infusion into the vein on Days 1, 8, 15 and 22 for the first 28 days (Cycle 1), and then on Day 1 of Cycles 3, 5, 7, 9 and 11
- Lenalidomide given as a pill once a day for the first 21 days of every 28-day cycle (12 in total), starting from Day 1 of Cycle 1
People who have certain side effects may also receive a treatment called tocilizumab, given as an infusion into the vein.
You will have an equal chance of being placed in either group.
This is an open-label clinical trial, which means that both you and your clinical trial doctor will know which treatment you are receiving.
How often will I be seen in follow-up appointments and for how long?
You will be given the clinical trial treatment for a total of 12 cycles, which will take roughly one year. During the treatment period, you will need to attend regular hospital visits, which will include checks to see how you are responding to treatment and any side effects that you might be having. You are free to stop this treatment at any time.
After you have had your last dose, you will still be seen regularly by the clinical trial doctor every three months for up to four years, as long as you agree to it. Your total time in the clinical trial will be roughly five years.
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/study/NCT04712097
Trial-identifier: NCT04712097
Trial Summary
This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy. Download brochure
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04712097 , GO42909 , 2020-005239-53
Trial Identifier
Mosunetuzumab, Lenalidomide, Rituximab, Tociluzumab
Treatments
Relapsed or Refractory Follicular Lymphoma
Condition
Official Title
Phase III Randomized, Open-Label, Multicenter Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Histologically documented CD20+ FL (Grades 1-3a)
- Requiring systemic therapy assessed by investigator based on tumor size and/or Groupe d'Etude des Lymphomes Folliculaires criteria
- Received at least one prior systemic lymphoma therapy, which included prior immunotherapy or chemoimmunotherapy
- Availability of a representative tumor specimen and the corresponding pathology report at the time of relapse/persistence for confirmation of the diagnosis of FL. Pretreatment sample of at least 1 core-needle, excisional or incisional tumor biopsy is required. Cytological or fine-needle aspiration samples are not acceptable. Fresh pretreatment biopsy is preferred. Patients who are unable to undergo biopsy procedures may be eligible for study enrollment if an archival tumor tissue sample (preferably from the most recent relapse/persistence) as paraffin blocks or at least 15 unstained slides, or in accordance with local regulatory requirements, can be sent to the Sponsor.
- Adequate hematologic function (unless due to underlying lymphoma, per the investigator)
- Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program.
- For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use 2 adequate methods of contraception, including at least 1 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 (including periods of treatment interruption), and for at least 28 days after the last dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab, and 12 months after final dose of rituximab. Women must refrain from donating eggs during this same period.
- For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined: 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 28 days after last dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab and 12 months after the final dose of rituximab. Men must refrain from donating sperm during this same period.
Exclusion Criteria
- Grade 3b FL
- History of transformation of indolent disease to diffuse-large B cell lymphoma
- Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy
- Active or history of CNS lymphoma or leptomeningeal infiltration
- Prior standard or investigational anti-cancer therapy as specified: Lenalidomide exposure within 12 months prior to Day 1 of Cycle 1; Chimeric antigen receptor T cell therapy within 30 days prior to Day 1 of Cycle 1; Radioimmunoconjugate within 12 weeks prior to Day 1 of Cycle 1; Monoclonal antibody or antibody-drug conjugate within 4 weeks prior to Cycle 1 Day 1; Treatment with any anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
- Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade </= 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0) prior to Day 1 of Cycle 1
- Treatment with systemic immunosuppressive medications, including, but not limited to prednisone (> 20 mg), 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 monoclonal antibodies
- Known sensitivity or allergy to murine products
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the mosunetuzumab, rituximab, tocilizumab, lenalidomide, or thalidomide formulation, including mannitol
- History of erythema multiforme, Grade >/= 3 rash, or blistering following prior treatment with immunomodulatory derivatives
- History of interstitial lung disease, drug-induced pneumonitis, and autoimmune pneumonitis
- 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 (EBV) infection
- Known or suspected history of hemophagocytic lymphohistiocytosis
- Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
- Active Hepatitis B infection
- Active Hepatitis C infection
- Known history of HIV positive status
- History of progressive multifocal leukoencephalopathy (PML)
- 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
- Active autoimmune disease requiring treatment
- History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- Prior allogeneic stem cell transplantation
- Contraindication to treatment for thromboembolism prophylaxis
- 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 (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
- 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
- Pregnant or lactating or intending to become pregnant during the study
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator'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
For the latest version of this information please go to www.forpatients.roche.com