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A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) (EPCORE DLBCL-2)

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ClinicalTrials.gov Identifier: NCT05578976
Recruitment Status : Recruiting
First Posted : October 13, 2022
Last Update Posted : April 9, 2024
Sponsor:
Collaborator:
Genmab
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE October 12, 2022
First Posted Date  ICMJE October 13, 2022
Last Update Posted Date April 9, 2024
Actual Study Start Date  ICMJE February 8, 2023
Estimated Primary Completion Date January 31, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2023)
Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5 [ Time Frame: Up to Approximately 46 Months ]
PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC), or death due to any cause whichever comes first.
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2022)
Number of Participants with Progression-Free Survival (PFS) [ Time Frame: Up to Approximately 43 Months ]
PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2023)
  • Number of Participants with PFS [ Time Frame: Up to Approximately 46 Months ]
    PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by IRC, or death due to any cause, whichever occurs first.
  • Number of Participants with Event-free survival (EFS) [ Time Frame: Up to Approximately 46 Months ]
    EFS is defined as the duration from randomization to the date of disease progression determined by Lugano criteria as assessed by IRC, IRC-assessed PR or SD followed by non protocol-specified NALT, a positive biopsy on or after end-of-treatment (EOT), regardless of whether NAL initiated, or death from any cause.
  • Percentage of Participants with Complete Remission (CR) [ Time Frame: On or After to Approximately 28 Weeks ]
    CR is defined as the absence of lymphoma determined by fluorodeoxyglucose positron emission tomography (FDG-PET),determined by Lugano 2014 criteria as assessed by IRC.
  • Overall survival (OS) [ Time Frame: Up to Approximately 76 Months ]
    OS is defined as time from randomization until death due to any causes.
  • Percentage of Participants with Minimal Residual Disease (MRD) Negativity [ Time Frame: Up to Approximately 46 Months ]
    The MRD negativity rate is defined as the percentage of participants who achieve MRD negativity prior to the initiation of any non-protocol-specified new anti-lymphoma therapy.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2022)
  • Number of Participants with Event-free survival (EFS) [ Time Frame: Up to Approximately 43 Months ]
    EFS is defined as the duration from randomization to the date of disease progression determined by Lugano 2014 criteria as assessed by IRC, Initiation of any non-protocol-specified new anti-lymphoma therapy for any reason, or death from any cause.
  • Percentage of Participants with Complete Remission (CR) [ Time Frame: Up to Approximately 28 Weeks ]
    CR is defined as the absence of lymphoma determined by fluorodeoxyglucose positron emission tomography (FDG-PET),determined by Lugano 2014 criteria as assessed by IRC.
  • Overall survival (OS) [ Time Frame: Up to Approximately 73 Months ]
    OS is defined as time from randomization until death due to any causes.
  • Percentage of Participants with Minimal Residual Disease (MRD) Negativity [ Time Frame: Up to Approximately 73 Months ]
    The MRD negativity rate is defined as the percentage of participants who achieve MRD negativity prior to the initiation of any non-protocol-specified new anti-lymphoma therapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Official Title  ICMJE A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Brief Summary

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.

In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B-Cell Lymphoma
Intervention  ICMJE
  • Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other Name: ABBV-GMAB-3013
  • Drug: Cyclophosphamide
    Intravenous (IV) Injection
  • Drug: Rituximab
    IV Infusion
  • Drug: Vincristine
    IV Infusion
  • Drug: Doxorubicin
    IV Infusion
  • Drug: Prednisone
    Oral; Tablet
Study Arms  ICMJE
  • Experimental: Epcoritamab and R-CHOP
    Participants will receive subcutaneous epcoritamab combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.
    Interventions:
    • Drug: Epcoritamab
    • Drug: Cyclophosphamide
    • Drug: Rituximab
    • Drug: Vincristine
    • Drug: Doxorubicin
    • Drug: Prednisone
  • Experimental: R-CHOP and Rituximab
    Participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.
    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Rituximab
    • Drug: Vincristine
    • Drug: Doxorubicin
    • Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2022)
900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2029
Estimated Primary Completion Date January 31, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
  • Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:

    • DLBCL, Not Otherwise Specified (NOS).
    • High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
    • T-cell/histiocyte-rich large B-cell lymphoma.
    • Epstein Barr virus-positive DLBCL, NOS.
    • Follicular lymphoma Grade 3b.

Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.

Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.

  • Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1.
  • Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
  • Has at least one target lesion defined as:

    • >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
    • Positron emission tomography (PET)-positive on PET-CT scan.
  • Laboratory values meeting the criteria laid out in the protocol.
  • Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.

Exclusion Criteria:

  • History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
  • Clinically significant cardiovascular disease as per the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Croatia,   Czechia,   Denmark,   France,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries Argentina,   Germany,   Mexico,   Slovakia,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT05578976
Other Study ID Numbers  ICMJE M20-621
2021-000168-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/
Current Responsible Party AbbVie
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AbbVie
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Genmab
Investigators  ICMJE
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP