Clinical trial • Phase III • Oncology
EPCORITAMAB for Follicular lymphoma (relapsed or refractory)
Phase III trial of EPCORITAMAB for Follicular lymphoma (relapsed or refractory).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Follicular lymphoma (relapsed or refractory)
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody | Small molecule | Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 01-03-2024
- First CTIS Authorization Date
- 08-04-2024
Trial design
Randomised, open-label, r2 (rituximab + lenalidomide) — rituximab (truxima) intravenous infusion; lenalidomide (revlimid) oral capsules (product information lists up to 20 mg daily); schedule details not specified in the available record.-controlled Phase III trial in Austria, Belgium, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- R2 (rituximab + lenalidomide) — Rituximab (Truxima) intravenous infusion; Lenalidomide (Revlimid) oral capsules (product information lists up to 20 mg daily); schedule details not specified in the available record.
- Target Sample Size
- 263
- Trial Duration For Participant
- 1440
Eligibility
Recruits 263 No vulnerable populations selected; participants are adults and must provide written informed consent. No assent or parental consent procedures are described in the available record..
- Vulnerable Population
- No vulnerable populations selected; participants are adults and must provide written informed consent. No assent or parental consent procedures are described in the available record.
Inclusion criteria
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.\n- Participant has: Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND >= 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI.\n- Histologically confirmed classic follicular lymphoma (FL) [previously Grade 1 to 3a FL] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.\n- Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)\n- Eligible to receive R2 per investigator determination."}
Exclusion criteria
- {"criterion_text":"- Documented refractoriness to lenalidomide.\n- Have lenalidomide exposure within 12 months prior to randomization."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-Free Survival (PFS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Best overall response (BOR) of CR or PR, determined by Lugano criteria (Appendix F), as assessed by an Independent Review Committee (IRC)","definition_or_measurement_approach":"Determined by Lugano criteria (Appendix F) as assessed by an Independent Review Committee (IRC)"}
Secondary endpoints
- {"endpoint_text":"- Percentage of Participants Achieving Complete Response (CR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity","definition_or_measurement_approach":""}
- {"endpoint_text":"- Changes from baseline in Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym).","definition_or_measurement_approach":""}
- {"endpoint_text":"- PFS, BOR, and CR during the study, determined per Lugano criteria as assessed by investigator.","definition_or_measurement_approach":"Determined per Lugano criteria as assessed by investigator"}
- {"endpoint_text":"- Duration of response (DOR), duration of complete response (DOCR), time to progression (TTP), and CR at the end of treatment (12 cycles), time to response (TTR), time to complete response (TTCR), per Lugano criteria as assessed by an IRC and by the investigator, respectively.","definition_or_measurement_approach":"Per Lugano criteria as assessed by IRC and by investigator (respectively)"}
- {"endpoint_text":"- Event-Free Survival (EFS), defined as the duration from randomization to the date of any of the following (whichever occurs first): •\tDisease progression determined by Lugano criteria as assessed by the investigator •\tInitiation of any non-protocol-specified new anti lymphoma therapy for any reason •\tDeath","definition_or_measurement_approach":"Defined as duration from randomization to earliest of progression (Lugano criteria by investigator), start of non-protocol anti-lymphoma therapy, or death"}
- {"endpoint_text":"- Time to next anti-lymphoma treatment (TTNLT).","definition_or_measurement_approach":""}
- {"endpoint_text":"- Changes from baseline in Patient-Reported Outcome Instruments (PROs; including Patient Global Impression of Severity [PGIS], Patient Global Impression of Change [PGIC], and EuroQol 5 dimension questionnaire, 5 level [EQ 5D 5L]).","definition_or_measurement_approach":"Changes from baseline in listed PRO instruments (PGIS, PGIC, EQ-5D-5L)"}
Recruitment
- Planned Sample Size
- 263
- Recruitment Window Months
- 92
- Consent Approach
- Written informed consent to be provided by participants. Country-specific informed consent documents are included (multiple country ICFs and pregnancy/pregnant-partner information forms are listed in the submitted documents). No specific assent/parental consent procedures are described in the available record.
Geography
- Total Number Of Sites
- 110
- Total Number Of Participants
- 263
Austria
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 29-04-2024
- Processing Time Days
- 46
- Number Of Sites
- 3
- Number Of Participants
- 13
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 18-04-2024
- Processing Time Days
- 35
- Number Of Sites
- 7
- Number Of Participants
- 7
Germany
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 26
- Number Of Sites
- 13
- Number Of Participants
- 6
Italy
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 11-04-2024
- Processing Time Days
- 28
- Number Of Sites
- 14
- Number Of Participants
- 28
Netherlands
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 26
- Number Of Sites
- 12
- Number Of Participants
- 24
Denmark
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 4
Greece
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 22-05-2024
- Processing Time Days
- 69
- Number Of Sites
- 5
- Number Of Participants
- 29
Poland
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 12-04-2024
- Processing Time Days
- 29
- Number Of Sites
- 5
- Number Of Participants
- 21
Slovakia
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 08-04-2024
- Processing Time Days
- 25
- Number Of Sites
- 2
- Number Of Participants
- 2
Czechia
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 10-04-2024
- Processing Time Days
- 27
- Number Of Sites
- 4
- Number Of Participants
- 14
Sweden
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 26
- Number Of Sites
- 3
- Number Of Participants
- 3
Hungary
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 12-04-2024
- Processing Time Days
- 29
- Number Of Sites
- 8
- Number Of Participants
- 19
Spain
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 09-04-2024
- Processing Time Days
- 26
- Number Of Sites
- 15
- Number Of Participants
- 53
France
- Earliest CTIS Part Ii Submission Date
- 14-03-2024
- Latest Decision Or Authorization Date
- 10-04-2024
- Processing Time Days
- 27
- Number Of Sites
- 17
- Number Of Participants
- 57
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Medidata Solutions Inc.
- Responsibilities
- eCRF/eCOA
- Name
- Endpoint Clinical Inc.
- Responsibilities
- code: 3
- Name
- Perceptive Informatics Inc.
- Responsibilities
- Medical Imaging, IRC
- Name
- Q Squared Solutions Limited
- Responsibilities
- code: 4
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCRF/eCOA","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":"code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"code: 2","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":"Perceptive Informatics Inc.","duties_or_roles":"Medical Imaging, IRC","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code: 4","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Epcoritamab (GEN3013)
- Active Substance
- EPCORITAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Not authorised (investigational product record prodAuthStatus=1)
- Orphan Designation
- Yes
- Investigational Product Name
- Revlimid 5 mg hard capsules
- Active Substance
- LENALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation EU)
- Frequency
- Daily (product listing: maxDailyDoseAmount 20 mg)
- Maximum Dose
- 20 mg
- Investigational Product Name
- Revlimid 20 mg hard capsules
- Active Substance
- LENALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation EU)
- Frequency
- Daily (product listing: maxDailyDoseAmount 20 mg)
- Maximum Dose
- 20 mg
- Investigational Product Name
- Truxima 100 mg concentrate for solution for infusion
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised (marketing authorisation EU)
- Maximum Dose
- 375 mg/m2
- Investigational Product Name
- Truxima 500 mg concentrate for solution for infusion
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised (marketing authorisation EU)
- Maximum Dose
- 375 mg/m2
- Combination Treatment
- Yes
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