MOSUNETUZUMAB for Follicular lymphoma

Inclusion criteria

• {"criterion_text":"- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2"}
• {"criterion_text":"- R/R FL after treatment with at least one prior systemic lymphoma therapy which includes prior immunotherapy or chemoimmunotherapy"}
• {"criterion_text":"- Previously untreated patients with FL must require systemic therapy assessed by investigator based on GELF criteria and have a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5"}
• {"criterion_text":"- Histologically documented FL of Grade 1, 2, or 3a, and that expresses CD20 as determined by the local laboratory"}
• {"criterion_text":"- Fluorodeoxyglucose avid lymphoma (i.e., positron emission tomography (PET) positive lymphoma)"}
• {"criterion_text":"- 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)"}

Exclusion criteria

• {"criterion_text":"- Any history of Grade 3b FL"}
• {"criterion_text":"- Any History of disease transformation and/or diffuse large B-cell lymphoma"}
• {"criterion_text":"- Active or history of central nervous system lymphoma or leptomeningeal infiltration"}
• {"criterion_text":"- Documented refractoriness to lenalidomide, defined as no response (PR or CR) within 6 months of therapy"}
• {"criterion_text":"- Prior standard or investigational anti-cancer therapy as specified"}
• {"criterion_text":"- Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade <=2 prior to Day 1 of Cycle 1"}

Primary endpoints

• {"endpoint_text":"- 1. Non-randomized Stage: Dose-limiting toxicity","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2. Non-randomized Stage: Incidence, nature, and severity of physical findings and adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5.0); for CRS, severity determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) cytokine-release syndrome (CRS) grading criteria","definition_or_measurement_approach":"Severity determined by NCI CTCAE v5.0; for CRS severity determined by ASTCT CRS grading criteria"}
• {"endpoint_text":"- 3. Non-randomized Stage : Change from baseline in targeted vital signs","definition_or_measurement_approach":"Change from baseline measurements of targeted vital signs (as specified in protocol)"}
• {"endpoint_text":"- 4. Non-randomized Stage : Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":"Change from baseline in targeted clinical laboratory test results (as specified in protocol)"}
• {"endpoint_text":"- 5. Non-randomized Stage : Tolerability, as assessed by the incidence of dose interruptions, dose reductions and dose intensity, and treatment discontinuation not due to efficacy events","definition_or_measurement_approach":"Tolerability assessed by incidence of dose interruptions, dose reductions, dose intensity metrics, and treatment discontinuations not due to efficacy"}
• {"endpoint_text":"- 6. ORR, defined as the proportion of patients whose best overall response is a PR or a CR during the study.","definition_or_measurement_approach":"Objective response rate (ORR) = proportion with best overall response of PR or CR during study"}
• {"endpoint_text":"- 7. Randomized stage: Cumulative Area under the concentration-time curve (AUC) over Cycles 1-3 (AUCC1-3)","definition_or_measurement_approach":"Pharmacokinetic measurement: cumulative AUC over cycles 1-3"}
• {"endpoint_text":"- 8. Randomized stage: Serum trough concentration at steady state, approximated by Cycle 4 (Ctrough, C4)","definition_or_measurement_approach":"Serum trough concentration at steady state approximated by Cycle 4"}

Secondary endpoints

• {"endpoint_text":"- 1. Non-randomized and Randomized stages : Complete response rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2. Non-randomized and Randomized stages : Objective response rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- 3. Non-randomized and Randomized stages : Duration of response","definition_or_measurement_approach":""}
• {"endpoint_text":"- 4. Non-randomized and Randomized stages : Duration of complete response","definition_or_measurement_approach":""}
• {"endpoint_text":"- 5. Non-randomized Stage : Minimum serum concentration (Cmin) of Mosun+ Len","definition_or_measurement_approach":""}
• {"endpoint_text":"- 6. Non-randomized Stage : Maximum serum concentration (Cmax) of Mosun+ Len","definition_or_measurement_approach":""}
• {"endpoint_text":"- 7. Randomized stage: Area under the concentration-time curve (AUC) of Mosun+ Len","definition_or_measurement_approach":""}
• {"endpoint_text":"- 8. Non-randomized and Randomized stages: Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study","definition_or_measurement_approach":""}
• {"endpoint_text":"- 9. Randomized stage: Incidence, nature, and severity of physical findings and adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5.0); for CRS, severity determined according to the ASTCT CRS grading criteria","definition_or_measurement_approach":"Severity determined by NCI CTCAE v5.0; for CRS severity determined by ASTCT CRS grading criteria"}
• {"endpoint_text":"- 10. Randomized stage: Change from baseline in targeted vital signs","definition_or_measurement_approach":""}
• {"endpoint_text":"- 11. Randomized stage: Change from baseline in targeted clinical laboratory test results","definition_or_measurement_approach":""}
• {"endpoint_text":"- 12. Randomized stage: Tolerability, as assessed by the incidence of dose interruptions, dose reductions and dose intensity, and treatment discontinuation not due to efficacy events","definition_or_measurement_approach":""}
• {"endpoint_text":"- 13. Randomized stage: Cumulative AUC over Cycles 1-2 (AUCC1-2)","definition_or_measurement_approach":""}
• {"endpoint_text":"- 14. Randomized stage: Serum trough concentration in Cycle 2 (Ctrough, C2)","definition_or_measurement_approach":""}
• {"endpoint_text":"- 15. Randomized stage: AUC at steady state (AUCss)","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

19-07-2023

Latest Decision Or Authorization Date

11-09-2025

Processing Time Days

785

Number Of Sites

6

Number Of Participants

78

Spain

Earliest CTIS Part Ii Submission Date

19-07-2023

Latest Decision Or Authorization Date

04-11-2025

Processing Time Days

839

Number Of Sites

4

Number Of Participants

39

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Fortrea Inc.

Responsibilities

Global CRO

Third parties

• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Independent review committee (IRC) response assessment, imaging collection","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Roche Molecular Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Netherlands","full_name":"QPS Netherlands B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}