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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04712097




Registration number
NCT04712097
Ethics application status
Date submitted
13/01/2021
Date registered
15/01/2021

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma
Scientific 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 With a Non-Randomized Single Arm US Extension of Mosunetuzumab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy
Secondary ID [1] 0 0
2020-005239-53
Secondary ID [2] 0 0
GO42909
Universal Trial Number (UTN)
Trial acronym
Celestimo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Follicular Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mosunetuzumab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Rituximab
Treatment: Drugs - Tociluzumab

Experimental: M + Len (Arm A) - Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)

Experimental: R + Len (Arm B) - Participants will receive weekly rituximab in Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11. Participants will also receive lenalidomide in Cycles 1-12. (Cycle length = 28 days for Cycles 1-12)

Experimental: M + Len (US Extension Arm C) - Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)


Treatment: Drugs: Mosunetuzumab
Participants will receive intravenous (IV) mosunetuzumab in a step-up dosing schedule on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-12

Treatment: Drugs: Lenalidomide
Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len)

Treatment: Drugs: Rituximab
Participants will receive IV rituximab on Days 1, 8, 15, and 22 of Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11

Treatment: Drugs: Tociluzumab
Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) according to 2014 Lugano Response Criteria
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression as determined by an independent review committee (IRC) or death from any cause (up to approximately 8 years)
Secondary outcome [1] 0 0
PFS as Determined by the Investigator
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or death from any cause (up to approximately 8 years)
Secondary outcome [2] 0 0
Complete Response Rate
Timepoint [2] 0 0
Up to approximately 8 years
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Up to approximately 8 years
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
From randomization to death from any cause (up to approximately 8 years)
Secondary outcome [5] 0 0
Duration of Objective Response (DOR)
Timepoint [5] 0 0
From the first occurrence of a documented objective response (complete response or partial response) to disease progression or death from any cause, whichever occurs first (up to approximately 8 years)
Secondary outcome [6] 0 0
Duration of Complete Reponse (DOCR)
Timepoint [6] 0 0
From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to approximately 8 years)
Secondary outcome [7] 0 0
Time to Deterioration in Physical Functioning and Fatigue, as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
Timepoint [7] 0 0
Up to approximately 8 years
Secondary outcome [8] 0 0
Time to Deterioration in Lymphoma Symptoms, as Measured by the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS)
Timepoint [8] 0 0
Up to approximately 8 years
Secondary outcome [9] 0 0
Percentage of Participants with Adverse Events (AEs)
Timepoint [9] 0 0
Up to approximately 8 years
Secondary outcome [10] 0 0
Serum Concentration of M + Len
Timepoint [10] 0 0
Up to approximately 8 years
Secondary outcome [11] 0 0
Area Under the Curve (AUC) of M + Len
Timepoint [11] 0 0
Up to approximately 8 years
Secondary outcome [12] 0 0
Percentage of Participants with Anti-Drug Antibodies (ADAs)
Timepoint [12] 0 0
Up to approximately 8 years
Secondary outcome [13] 0 0
Time to Next Anti-Lymphoma Treatment (TTNALT)
Timepoint [13] 0 0
From randomization to the first documented administration of a new anti-lymphoma treatment (up to approximately 8 years)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2029
Actual
Sample size
Target
474
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital; Haematology Clinical Trials - Adelaide
Recruitment hospital [4] 0 0
Geelong Hospital; Andrew Love Cancer Centre - Geelong
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
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United States of America
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Indiana
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Texas
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United States of America
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Washington
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United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
Brazil
State/province [15] 0 0
PR
Country [16] 0 0
Brazil
State/province [16] 0 0
RS
Country [17] 0 0
Brazil
State/province [17] 0 0
SP
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China
State/province [18] 0 0
Beijing City
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China
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Beijing
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China
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Changchun City
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China
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Guangzhou City
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China
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Harbin
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China
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Nanchang
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China
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Nanjing
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China
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Shanghai City
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China
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Shanghai
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China
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Tianjin City
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China
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Tianjin
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China
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Wuhan City
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China
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Xiamen
Country [31] 0 0
China
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Zhejiang
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China
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Zhengzhou
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France
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Bayonne
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France
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Chambery
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France
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Creteil
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France
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Lille
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France
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Marseille
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Montpellier
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France
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Nantes
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France
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Nice
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France
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Nimes
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France
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Paris
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France
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Pessac
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France
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Pierre Benite
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France
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Poitiers
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France
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Reims
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France
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Rennes
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France
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Rouen
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France
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St Priest En Jarez
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France
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Strasbourg
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Germany
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Augsburg
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Germany
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Bamberg
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Germany
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Berlin
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Germany
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Chemnitz
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Germany
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Dresden
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Germany
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Düsseldorf
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Germany
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Giessen
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Germany
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Halle (Saale)
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Germany
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Heidelberg
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Germany
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Homburg/Saar
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Germany
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Kaiserslautern
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Germany
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Kiel
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Germany
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Luebeck
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Germany
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München
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Germany
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Regensburg
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Germany
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Rostock
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Germany
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Ulm
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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Marche
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Italy
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Puglia
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Veneto
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Hokkaido
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Japan
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Kumamoto
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Japan
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Kyoto
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Japan
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Mie
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Busan
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Korea, Republic of
State/province [86] 0 0
Seongnam-si
Country [87] 0 0
Korea, Republic of
State/province [87] 0 0
Seoul
Country [88] 0 0
Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Katowice
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Poland
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Olsztyn
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Poland
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Pozna?
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Poland
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Warszawa
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Poland
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Wroc?aw
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Russian Federation
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Moskovskaja Oblast
Country [96] 0 0
Russian Federation
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Niznij Novgorod
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Penza
Country [98] 0 0
Spain
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Guipuzcoa
Country [99] 0 0
Spain
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Madrid
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Spain
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Murcia
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Spain
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Sevilla
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Spain
State/province [102] 0 0
Valencia
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Taiwan
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Kaoisung
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Taiwan
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Taipei City
Country [105] 0 0
Taiwan
State/province [105] 0 0
Taipei
Country [106] 0 0
Taiwan
State/province [106] 0 0
Taoyuan
Country [107] 0 0
Turkey
State/province [107] 0 0
?eh?tkam?l
Country [108] 0 0
Turkey
State/province [108] 0 0
Ankara
Country [109] 0 0
Turkey
State/province [109] 0 0
Istanbul
Country [110] 0 0
Turkey
State/province [110] 0 0
Kayseri
Country [111] 0 0
Turkey
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Sariyer
Country [112] 0 0
Turkey
State/province [112] 0 0
Trabzon
Country [113] 0 0
Ukraine
State/province [113] 0 0
Kharkiv Governorate
Country [114] 0 0
Ukraine
State/province [114] 0 0
KIEV Governorate
Country [115] 0 0
Ukraine
State/province [115] 0 0
Kiev
Country [116] 0 0
Ukraine
State/province [116] 0 0
Kyiv
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Cornwall
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Gloucester
Country [119] 0 0
United Kingdom
State/province [119] 0 0
London
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Nottingham
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Sutton
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Torquay

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID: GO42909 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04712097