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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505807-21-00
Acronym
GO42909
Enrollment
150
Registered
2024-11-07
Start date
2021-11-16
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/refractory follicular lymphoma

Brief summary

Arm A and Arm B : 1. Progression-free survival as determined by the IRC with use of the 2014 Lugano Response Criteria or death from any cause in the intent-to-treat (ITT) population, Arm C : 2. Objective response rate, as defined as the proportion of patients whose best overall response is a PR or a CR during the study, as determined by the IRC

Detailed description

1. Arm A and Arm B: Progression-free survival as determined by the investigator in the ITT population. Arm C: Progression-free survival as determined by the investigator and IRC in the ITT population., 2. Arm A, Arm B and Arm C: Complete response rate in the ITT population as determined by the IRC and investigator, 3. Arm A, Arm B and Arm C: Objective response rate in the ITT population as determined by the IRC and investigator, 4. Arm A, Arm B and Arm C: Overall survival in the ITT population, 5. Arm A, Arm B and Arm C: Duration of objective response (DOR), 6. Arm A, Arm B and Arm C: Duration of CR, 7. Arm A, Arm B and Arm C: 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), 8. Arm A, Arm B and Arm C:Time to deterioration in lymphoma symptoms, as measured by the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS), 9. Arm A, Arm B and Arm C : Time to next anti-lymphoma treatment (TTNALT), defined as the time from randomization to the first documented administration of a new anti-lymphoma treatment, 10. Arm A, Arm B and Arm C: Incidence and severity of adverse events, with severity determined according to the NCI CTCAE, v5.0, including cytokine release syndrome (CRS), with severity determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS grading criteria, 11. Arm A, Arm B and Arm C: Change from baseline in targeted vital signs, 12. Arm A, Arm B and Arm C: Change from baseline in targeted clinical laboratory test results, 13. Arm A, Arm B and Arm C: Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, and study treatment discontinuation because of adverse events, 14. Arm A, Arm B and Arm C: Minimum observed concentration (Cmin) of Mosunetuzumab, 15. Arm A, Arm B and Arm C: Cmin of Lenalidomide, 16. Arm A, Arm B and Arm C: Maximum observed concentration (Cmax) of Mosunetuzumab, 17. Arm A, Arm B and Arm C: Cmax of Lenalidomide, 18. Arm A, Arm B and Arm C: Area under the concentration-time curve (AUC) of Mosunetuzumab, 19. Arm A, Arm B and Arm C: AUC of Lenalidomide, 20. Arm A, Arm B and Arm C: Prevalence of anti-drug antibodies (ADAs) against mosunetuzumab at baseline, 21. Arm A and Arm B: Prevalence of ADAs against rituximab at baseline, 22. Arm A, Arm B and Arm C: Incidence of ADAs against mosunetuzumab during the study, 23. Arm A and Arm B: Incidence of ADAs against rituximab during the study, 24. Arm A and Arm B: Cmin of Rituximab, 25. Arm A and Arm B: Cmax of Rituximab, 26. Arm A and Arm B: AUC of Rituximab

Interventions

None listed

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Arm A and Arm B : 1. Progression-free survival as determined by the IRC with use of the 2014 Lugano Response Criteria or death from any cause in the intent-to-treat (ITT) population, Arm C : 2. Objective response rate, as defined as the proportion of patients whose best overall response is a PR or a CR during the study, as determined by the IRC

Secondary

MeasureTime frame
1. Arm A and Arm B: Progression-free survival as determined by the investigator in the ITT population. Arm C: Progression-free survival as determined by the investigator and IRC in the ITT population., 2. Arm A, Arm B and Arm C: Complete response rate in the ITT population as determined by the IRC and investigator, 3. Arm A, Arm B and Arm C: Objective response rate in the ITT population as determined by the IRC and investigator, 4. Arm A, Arm B and Arm C: Overall survival in the ITT population, 5. Arm A, Arm B and Arm C: Duration of objective response (DOR), 6. Arm A, Arm B and Arm C: Duration of CR, 7. Arm A, Arm B and Arm C: 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), 8. Arm A, Arm B and Arm C:Time to deterioration in lymphoma symptoms, as measured by the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS), 9. Arm A, Arm

Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026