GLOFITAMAB for Diffuse large B-cell lymphoma

Inclusion criteria

• {"criterion_text":"- Previously untreated patients with cluster of differential (CD20)-positive DLBCL, including diagnoses by the 2016 World Health Organization (WHO) classification of lymphoid neoplasms"}
• {"criterion_text":"- International Prognostic Index (IPI): 1-5"}
• {"criterion_text":"- Life expectancy of >=6 months"}
• {"criterion_text":"- Adequate biomarker blood samples prior to initiation of R-CHOP on Day 1 of Cycle 1 and on Day 1 of Cycle 2 submitted for screening for determination of ctDNA status"}
• {"criterion_text":"- At least one bi-dimensionally fluorodeoxyglucose (FDG)-avid measurable lymphoma lesion on positron emission tomography/computed tomography (PET/CT) scan"}
• {"criterion_text":"- Left ventricular ejection fraction (LVEF) >=50%, as determined on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)"}

Exclusion criteria

• {"criterion_text":"- Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines, history of severe allergic or anaphylactic reactions to murine monoclonal antibodies, or known sensitivity or allergy to murine products"}
• {"criterion_text":"- Prior treatment for indolent lymphoma"}
• {"criterion_text":"- Prior solid organ or allogeneic stem cell transplant"}
• {"criterion_text":"- Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable"}
• {"criterion_text":"- Prior therapy for DLBCL and high-grade B-cell lymphoma (HGBCL) with the exception of palliative, short-term treatment with corticosteroids"}
• {"criterion_text":"- Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the final dose of R-CHOP, 3 months after the final dose of tocilizumab (if applicable), or 2 months after the final dose of glofitamab"}

Primary endpoints

• {"endpoint_text":"- 1. EOT CR rate, as determined by the investigator according to the 2014 Lugano Response Criteria for Malignant Lymphoma","definition_or_measurement_approach":"Determined by the investigator according to the 2014 Lugano Response Criteria for Malignant Lymphoma"}

Secondary endpoints

• {"endpoint_text":"- 1. ORR at the EOT, as determined by the investigator according to the 2014 Lugano Response Criteria","definition_or_measurement_approach":"As determined by the investigator according to the 2014 Lugano Response Criteria"}
• {"endpoint_text":"- 2. PFS, as determined by the investigator according to the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first","definition_or_measurement_approach":"As determined by the investigator according to the 2014 Lugano Response Criteria or death due to any cause"}
• {"endpoint_text":"- 3. OS","definition_or_measurement_approach":"Overall survival (OS) - as stated"}
• {"endpoint_text":"- 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)","definition_or_measurement_approach":"Adverse events classified and graded per NCI CTCAE v5.0"}
• {"endpoint_text":"- 5. Tolerability, as assessed by dose modifications, dose intensity, and study treatment discontinuation because of adverse events","definition_or_measurement_approach":"Assessed by dose modifications, dose intensity, and treatment discontinuation due to adverse events"}
• {"endpoint_text":"- 6. Serum concentrations of glofitamab at specified timepoints","definition_or_measurement_approach":"Serum concentrations measured at specified timepoints (pharmacokinetic assessment)"}
• {"endpoint_text":"- 7. Serum trough concentrations of glofitamab at specified timepoints","definition_or_measurement_approach":"Trough concentrations measured at specified timepoints"}
• {"endpoint_text":"- 8. Maximum concentration (Cmax) of glofitamab at specified timepoints","definition_or_measurement_approach":"Cmax measured at specified timepoints"}
• {"endpoint_text":"- 9. Area under the concentration–time curve (AUC) of glofitamab at specified timepoints","definition_or_measurement_approach":"AUC determined from concentration–time data at specified timepoints"}
• {"endpoint_text":"- 10. Relationship between ADA status and efficacy, safety, or PK endpoints","definition_or_measurement_approach":"Assessment of relationship between anti-drug antibody (ADA) status and efficacy, safety, and PK endpoints"}

Denmark

Earliest CTIS Part Ii Submission Date

26-04-2024

Latest Decision Or Authorization Date

17-05-2024

Processing Time Days

21

Number Of Sites

1

Number Of Participants

2

France

Earliest CTIS Part Ii Submission Date

26-04-2024

Latest Decision Or Authorization Date

22-05-2024

Processing Time Days

26

Number Of Sites

2

Number Of Participants

6

Spain

Earliest CTIS Part Ii Submission Date

26-04-2024

Latest Decision Or Authorization Date

17-05-2024

Processing Time Days

21

Number Of Sites

4

Number Of Participants

6

Netherlands

Earliest CTIS Part Ii Submission Date

26-04-2024

Latest Decision Or Authorization Date

17-05-2024

Processing Time Days

21

Number Of Sites

1

Number Of Participants

2

Poland

Earliest CTIS Part Ii Submission Date

26-04-2024

Latest Decision Or Authorization Date

20-05-2024

Processing Time Days

24

Number Of Sites

2

Number Of Participants

4

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

PPD Development L.P.

Responsibilities

code:4

Name

QPS Netherlands B.V.

Responsibilities

code:4

Name

Almac Clinical Technologies LLC

Responsibilities

code:3

Name

Worldcare Clinical LLC

Responsibilities

Imaging

Name

Q Squared Solutions Limited

Responsibilities

code:4

Third parties

• {"country":"United States","full_name":"Roche Molecular Systems Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Worldcare Clinical LLC","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"PPD Development L.P.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"QPS Netherlands B.V.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}