Clinical trial • Phase III • Oncology
EPCORITAMAB for Diffuse large B-cell lymphoma
Phase III trial of EPCORITAMAB for Diffuse large B-cell lymphoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Diffuse large B-cell lymphoma
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody|Monoclonal antibody|Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 29-02-2024
- First CTIS Authorization Date
- 08-04-2024
Trial design
Randomised, open-label, r-chop: rituximab (truxima 100 mg / 500 mg listed; dose field lists 375 mg/m2), cyclophosphamide (cyclophosphamide injection 500 mg; max listed 750 mg/m2), doxorubicin (doxorubicinhydrochlorid; max listed 50 mg/m2), vincristine (vincristine sulfate 1 mg/ml; max listed 2 mg), and prednisone (prednisone 5 mg tablets; max listed 100 mg) — administered as standard r-chop for 6 cycles (per protocol) with subsequent 2 cycles of rituximab in the comparator arm.-controlled Phase III trial in Slovakia, Austria, Poland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- R-CHOP: rituximab (Truxima 100 mg / 500 mg listed; dose field lists 375 mg/m2), cyclophosphamide (Cyclophosphamide Injection 500 mg; max listed 750 mg/m2), doxorubicin (Doxorubicinhydrochlorid; max listed 50 mg/m2), vincristine (Vincristine Sulfate 1 mg/ml; max listed 2 mg), and prednisone (Prednisone 5 mg tablets; max listed 100 mg) — administered as standard R-CHOP for 6 cycles (per protocol) with subsequent 2 cycles of rituximab in the comparator arm.
- Target Sample Size
- 542
Eligibility
Recruits 542 No vulnerable populations selected; participants are adults (Age ≥ 18). Informed consent to be provided by the participant; no assent procedures or other special vulnerable-population consent procedures are described in the CTIS record..
- Vulnerable Population
- No vulnerable populations selected; participants are adults (Age ≥ 18). Informed consent to be provided by the participant; no assent procedures or other special vulnerable-population consent procedures are described in the CTIS record.
Inclusion criteria
- {"criterion_text":"- Age ≥ 18 years old and < 80 years old, with a life expectancy of ≥ 12 months."}
- {"criterion_text":"- Subject is planned to receive treatment with 6 cycles of standard R CHOP per investigator determination."}
- {"criterion_text":"- Subject must have an IPI score of 2-5. The number of subjects with an IPI 2 of will not exceed approximately 30% of the overall sample size."}
Exclusion criteria
- {"criterion_text":"- Subject with history of prior systemic anti-lymphoma therapy for DLBCL (including any definitive radiotherapy with curative intent) other than corticosteroids with or without vincristine during pre-phase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment."}
- {"criterion_text":"- Subject has clinically significant cardiovascular disease, including: • Myocardial infarction or stroke within 6 months prior to enrollment. OR • The following conditions within 3 months prior to enrollment: unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III IV), uncontrolled cardiac arrhythmia OR • Screening 12-lead electrocardiogram showing a baseline QT interval as corrected by Fridericia's formula > 470 msec (male) or > 480 msec (female) OR • Other clinically significant ECG abnormalities within 6 months prior to enrollment unless deemed stable and appropriately treated."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is PFS defined as the duration from the date of randomization to the date of any of the following (whichever occurs first). The primary analysis population is the subset of subjects with an IPI of 3-5","definition_or_measurement_approach":"PFS defined as duration from randomization to the date of any of the listed events (whichever occurs first); primary analysis population: subjects with IPI 3-5."}
- {"endpoint_text":"- Death due to any causes.","definition_or_measurement_approach":"All-cause mortality measured from randomization."}
- {"endpoint_text":"- Disease progression based on the independent review committee (IRC) assessment per Lugano criteria.","definition_or_measurement_approach":"Progression assessed by an Independent Review Committee (IRC) using the Lugano criteria."}
Secondary endpoints
- {"endpoint_text":"- PFS in all randomized subjects.","definition_or_measurement_approach":"Progression-free survival measured in all randomized subjects."}
- {"endpoint_text":"- CR on or after the EOT based on the IRC assessment per Lugano criteria, where EOT is defined as treatment completion or early treatment discontinuation.","definition_or_measurement_approach":"Complete response (CR) assessed by IRC per Lugano criteria at or after end of treatment (EOT), where EOT = treatment completion or early discontinuation."}
- {"endpoint_text":"- OS, defined as time from randomization until death due to any causes.","definition_or_measurement_approach":"Overall survival measured from randomization until death from any cause."}
- {"endpoint_text":"- MRD negativity.","definition_or_measurement_approach":"Minimal residual disease (MRD) negativity as specified in protocol (methodology not detailed in CTIS record)."}
Recruitment
- Registry Or Advocacy Recruitment
- Yes
- Planned Sample Size
- 542
- Recruitment Window Months
- 77
- Consent Approach
- Informed consent is provided by the adult participant (Age ≥ 18). Country-specific informed consent forms (ICFs) are available; ICF documents in the CTIS record include multiple national-language versions (examples in the document list: Slovak, German (Austria), Polish, Danish, Hungarian, Dutch, Czech, Greek, Portuguese, Bulgarian, English, Swedish, Spanish, French, Italian). No assent procedures for minors are described (trial enrols adults only).
Geography
- Total Number Of Sites
- 149
- Total Number Of Participants
- 435
Slovakia
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 25
- Number Of Sites
- 2
- Number Of Participants
- 21
Austria
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 15-04-2024
- Processing Time Days
- 31
- Number Of Sites
- 4
- Number Of Participants
- 27
Poland
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 12-04-2024
- Processing Time Days
- 28
- Number Of Sites
- 7
- Number Of Participants
- 16
Denmark
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 25
- Number Of Sites
- 5
- Number Of Participants
- 22
Hungary
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 25
- Number Of Sites
- 9
- Number Of Participants
- 24
Netherlands
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 08-04-2024
- Processing Time Days
- 24
- Number Of Sites
- 26
- Number Of Participants
- 53
Czechia
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 10-04-2024
- Processing Time Days
- 26
- Number Of Sites
- 6
- Number Of Participants
- 25
Greece
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 20-05-2024
- Processing Time Days
- 66
- Number Of Sites
- 7
- Number Of Participants
- 15
Sweden
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 25
- Number Of Sites
- 5
- Number Of Participants
- 3
Portugal
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 25
- Number Of Sites
- 4
- Number Of Participants
- 12
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 10-05-2024
- Processing Time Days
- 56
- Number Of Sites
- 2
- Number Of Participants
- 8
Belgium
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 07-05-2024
- Processing Time Days
- 53
- Number Of Sites
- 12
- Number Of Participants
- 22
Italy
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 30-04-2024
- Processing Time Days
- 46
- Number Of Sites
- 16
- Number Of Participants
- 57
Croatia
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 25
- Number Of Sites
- 4
- Number Of Participants
- 8
Spain
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 25
- Number Of Sites
- 16
- Number Of Participants
- 52
France
- Earliest CTIS Part Ii Submission Date
- 15-03-2024
- Latest Decision Or Authorization Date
- 11-04-2024
- Processing Time Days
- 27
- Number Of Sites
- 24
- Number Of Participants
- 70
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Cytel Inc.
- Responsibilities
- Service provider to assist with iDMC activities
- Name
- Medidata Solutions Inc.
- Responsibilities
- ePRO and eCRF
- Name
- Greenphire LLC
- Responsibilities
- Patient Reimbursement
- Name
- Perceptive Informatics Inc.
- Responsibilities
- Medical Imaging, IRC
Third parties
- {"country":"United States","full_name":"Avantor Inc.","duties_or_roles":"Thermometer Supplier","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Service provider to assist with iDMC activities","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"ePRO and eCRF","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"Labcorp","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical Imaging, IRC","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Epcoritamab (GEN3013)
- Active Substance
- EPCORITAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Orphan Designation
- Yes
- Combination Treatment
- Yes
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