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NCT Number: NCT06191744

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with previously untreated FL. Adverse events and change in disease condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world.

Participants will receive R2 (intravenous [IV] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) [G-CHOP]/ R-CHOP or G and IV infusion of bendamustine (Benda) [G-Benda]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment.

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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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Key information

Conditions

Follicular Lymphoma (FL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Prince Alfred Hospital /ID# 259320, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of follicular lymphoma (FL).
  • Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
  • Are willing and able to comply with procedures required in the protocol.
  • Must have stage, III, IV or II with bulky disease >= 7cm).
  • Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
  • Has one or more target lesions:
  • A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
  • >=1 measurable nodal lesion (long axis >1.5cm) or >=1 measurable extra-nodal lesion (long axis >1.0 cm) on CT scan or MRI
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: [Arm B] at the discretion of the Investigator, and rituximab and lenalidomide (R2) [Arm C].
  • Have laboratory values meeting the criteria in the protocol.

Exclusion criteria

  • Had major surgery within 4 weeks prior to randomization.
  • Have active cytomegalovirus (CMV) disease.

Treatment and study plan

Epcoritamab

Drug

Subcutaneous (SC) Injection

Other names: ABBV-GMAB-3013, GEN3013, Epkinly

Prednisone

Drug

Oral Tablet

Rituximab

Drug

Intravenous (IV) Infusion

Lenalidomide

Drug

Oral Capsule

Doxorubicin

Drug

IV Injection

Vincristine

Drug

IV Injection

Cyclophosphamide

Drug

IV Injection

Obinutuzumab

Drug

IV Infusion

Bendamustine

Drug

IV Infusion

Primary outcomes

  1. Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)

    Time frame: Up to 30 Months

    CR30 will be determined by positron emission tomography-computerized tomography (cat scan) [PET-CT] per Lugano 2014 criteria, as assessed by independent review committee (IRC).

  2. Arm A1 vs Arm B: Number of Participants with Progression-free survival (PFS)

    Time frame: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

Secondary outcomes

  1. Arm A1 vs Arm B: Overall Survival (OS)

    Time frame: Up to 10 Years

    OS is defined as the time from the date of randomization to the date of death of any cause.

  2. Arm A1 vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate

    Time frame: Up to 10 Years

    MRD negativity rate, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with follicular lymphoma (FL) MRD at baseline.

  3. Arm A1 vs Arm B: Change from Baseline in Physical Functioning (PF) According to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30)

    Time frame: 21 Weeks

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

  4. Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30

    Time frame: Up to 30 Months

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

  5. Arm A1 vs Arm C: Percentage of Participants who Achieve CR30

    Time frame: Up to 30 Months

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

  6. Arm A1 vs Arm A2: Number of Participants with PFS

    Time frame: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

  7. Arm A1 vs Arm C: Number of Participants with PFS

    Time frame: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

  8. Arm A1 vs Arm A2: Rate of MRD Negativity

    Time frame: Up to 10 Years

    MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.

  9. Arm A1 vs Arm C: Rate of MRD Negativity

    Time frame: Up to 10 Years

    MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.

  10. Arm A1 vs Arm A2: Change from Baseline in PF According to EORTC QLQ-C30

    Time frame: Up to 10 Years

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

  11. Arm A1 vs Arm C: Change from Baseline in PF According to EORTC QLQ-C30

    Time frame: Up to 10 Years

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

  12. Arm A1 vs Arm A2: OS

    Time frame: Up to 10 Years

    OS is defined as the time from the date of randomization to the date of death of any cause.

  13. Arm A1 vs Arm C: OS

    Time frame: Up to 10 Years

    OS is defined as the time from the date of randomization to the date of death of any cause.

  14. Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30

    Time frame: Up to 30 Months

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

  15. Arm A1 vs Arm B: Percentage of Participants who Achieve CR30

    Time frame: Up to 30 Months

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

  16. Arm A1 vs Arm C: Percentage of Participants who Achieve CR30

    Time frame: Up to 30 Months

    CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

  17. Arm A1 vs Arm A2: Number of Participants with PFS

    Time frame: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

  18. Arm A1 vs Arm B: Number of Participants with PFS

    Time frame: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

  19. Arm A1 vs Arm C: Number of Participants with PFS

    Time frame: Up to 10 Years

    PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

  20. Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per IRC

    Time frame: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

  21. Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per Investigator

    Time frame: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

  22. Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per IRC

    Time frame: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

  23. Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per Investigator

    Time frame: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

  24. Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per IRC

    Time frame: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

  25. Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per Investigator

    Time frame: Up to 10 Years

    CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.

  26. Arm A1 vs Arm A2: Number of Participants with Best Overall Response (BOR) per per Investigator

    Time frame: Up to 10 Years

    BOR is defined as the percentage of participants who achieve CR or partial response (PR) determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

  27. Arm A1 vs Arm A2: Number of Participants with BOR per IRC

    Time frame: Up to 10 Years

    BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.

  28. Arm A1 vs Arm B: Number of Participants with BOR per Investigator

    Time frame: Up to 10 Years

    BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

  29. Arm A1 vs Arm B: Number of Participants with BOR per IRC

    Time frame: Up to 10 Years

    BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.

  30. Arm A1 vs Arm C: Number of Participants with BOR per Investigator

    Time frame: Up to 10 Years

    BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

  31. Arm A1 vs Arm C: Number of Participants with BOR per IRC

    Time frame: Up to 10 Years

    BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.

  32. Arm A1 vs Arm A2: Number of Participants with Event-free Survival (EFS) per IRC

    Time frame: Up to 10 Years

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

  33. Arm A1 vs Arm A2: Number of Participants with EFS per Investigator

    Time frame: Up to 10 Years

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

  34. Arm A1 vs Arm B: Number of Participants with EFS per IRC

    Time frame: Up to 10 Years

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

  35. Arm A1 vs Arm B: Number of Participants with EFS per Investigator

    Time frame: Up to 10 Years

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

  36. Arm A1 vs Arm C: Number of Participants with EFS per IRC

    Time frame: Up to 10 Years

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

  37. Arm A1 vs Arm C: Number of Participants with EFS per Investigator

    Time frame: Up to 10 Years

    EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.

  38. Arm A1 vs Arm A2: Duration of Response (DOR) per IRC

    Time frame: Up to 10 Years

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

  39. Arm A1 vs Arm A2: DOR per Investigator

    Time frame: Up to 10 Years

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

  40. Arm A1 vs Arm B: DOR per IRC

    Time frame: Up to 10 Years

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

  41. Arm A1 vs Arm B: DOR per Investigator

    Time frame: Up to 10 Years

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

  42. Arm A1 vs Arm C: DOR per IRC

    Time frame: Up to 10 Years

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

  43. Arm A1 vs Arm C: DOR per Investigator

    Time frame: Up to 10 Years

    DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

  44. Arm A1 vs Arm A2: Duration of Complete Response (DOCR) per IRC

    Time frame: Up to 10 Years

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

  45. Arm A1 vs Arm A2: DOCR per Investigator

    Time frame: Up to 10 Years

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

  46. Arm A1 vs Arm B: DOCR per IRC

    Time frame: Up to 10 Years

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

  47. Arm A1 vs Arm B: DOCR per Investigator

    Time frame: Up to 10 Years

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

  48. Arm A1 vs Arm C: DOCR per IRC

    Time frame: Up to 10 Years

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.

  49. Arm A1 vs Arm C: DOCR per Investigator

    Time frame: Up to 10 Years

    DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.

  50. Arm A1 vs Arm A2: Time to Next Anti-lymphoma Therapy (TTNT) per Investigator

    Time frame: Up to 10 Years

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

  51. Arm A1 vs Arm A2: TTNT per IRC

    Time frame: Up to 10 Years

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

  52. Arm A1 vs Arm A2: TTNT per Investigator

    Time frame: Up to 10 Years

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

  53. Arm A1 vs Arm B: TTNT per IRC

    Time frame: Up to 10 Years

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

  54. Arm A1 vs Arm B: TTNT per Investigator

    Time frame: Up to 10 Years

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

  55. Arm A1 vs Arm C: TTNT per IRC

    Time frame: Up to 10 Years

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

  56. Arm A1 vs Arm C: TTNT per Investigator

    Time frame: Up to 10 Years

    TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.

  57. Arm A1 vs Arm A2: Time to Progression per IRC

    Time frame: Up to 10 Years

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.

  58. Arm A1 vs Arm A2: Time to Progression per Investigator

    Time frame: Up to 10 Years

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.

  59. Arm A1 vs Arm B: Time to Progression per IRC

    Time frame: Up to 10 Years

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.

  60. Arm A1 vs Arm B: Time to Progression per Investigator

    Time frame: Up to 10 Years

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.

  61. Arm A1 vs Arm C: Time to Progression per IRC

    Time frame: Up to 10 Years

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.

  62. Arm A1 vs Arm C: Time to Progression per Investigator

    Time frame: Up to 10 Years

    Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.

  63. Arm A1 vs Arm A2: Number of Participants with Progression-free Survival After Subsequent Anti-Lymphoma Therapy (PFS2)

    Time frame: Up to 10 Years

    PFS2 is defined as the time after subsequent anti-lymphoma therapy to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

  64. Arm A1 vs Arm B: Number of Participants with PFS2

    Time frame: Up to 10 Years

    PFS2 is defined as the time after subsequent anti-lymphoma therapy to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

  65. Arm A1 vs Arm C: Number of Participants with PFS2

    Time frame: Up to 10 Years

    PFS2 is defined as the time after subsequent anti-lymphoma therapy to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

  66. Arm A1 vs Arm A2: Change in Tolerability as Measured by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Time frame: Up to 10 Years

    The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence.

  67. Arm A1 vs Arm B: Change in Tolerability as Measured by PRO-CTCAE

    Time frame: Up to 10 Years

    The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence.

  68. Arm A1 vs Arm C: Change in Tolerability as Measured by PRO-CTCAE

    Time frame: Up to 10 Years

    The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence.

  69. Arm A1 vs Arm A2: Change in Tolerability as Measured by The Functional Assessment of Cancer Therapy - General (FACT-G) Item GP5

    Time frame: Up to 10 Years

    The functional assessment of cancer therapy singly item - GP5 (FACT-GP5) is a single question asking if participant is bothered by side effects of treatment.

  70. Arm A1 vs Arm B: Change in Tolerability as Measured by FACT-G Item GP5

    Time frame: Up to 10 Years

    The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.

  71. Arm A1 vs Arm C: Change in Tolerability as Measured by FACT-GG Item GP5

    Time frame: Up to 10 Years

    The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.

  72. Arm A1 vs Arm A2: Change in Symptoms as Measured by The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

    Time frame: Up to 10 Years

    The objective of the FACT-Lym patient reported outcome (PRO) is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

  73. Arm A1 vs Arm B: Change in Symptoms as Measured by FACT-Lym

    Time frame: Up to 10 Years

    The objective of the FACT-Lym patient reported outcome (PRO) is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

  74. Arm A1 vs Arm C: Change in Symptoms as Measured by FACT-Lym

    Time frame: Up to 10 Years

    The objective of the FACT-Lym patient reported outcome (PRO) is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

  75. Arm A1 vs Arm A2: Change in Quality of Life (QoL) as Measured by FACT-Lym

    Time frame: Up to 10 Years

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

  76. Arm A1 vs Arm B: Change in QoL as Measured by FACT-Lym

    Time frame: Up to 10 Years

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

  77. Arm A1 vs Arm C: Change in QoL as Measured by FACT-Lym

    Time frame: Up to 10 Years

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

  78. Arm A1 vs Arm A2: Time-to-first PRO deterioration (TTD) in well-being using the lymphoma subscale (LymS) of FACT-Lym

    Time frame: Up to 10 Years

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

  79. Arm A1 vs Arm B: TTD in well-being using LymS of FACT-Lym

    Time frame: Up to 10 Years

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

  80. Arm A1 vs Arm C: TTD in well-being using LymS of FACT-Lym

    Time frame: Up to 10 Years

    The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.

  81. Arm A1 vs Arm A2: Change in QoL as Measured by 5-Level European Quality of Life (EuroQol)-5-dimension [EQ-5D-5L]

    Time frame: Up to 10 Years

    The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.

  82. Arm A1 vs Arm B: Change in QoL as Measured by EQ-5D-5L

    Time frame: Up to 10 Years

    The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.

  83. Arm A1 vs Arm C: Change in QoL as Measured by EQ-5D-5L

    Time frame: Up to 10 Years

    The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.

  84. Arm A1 vs Arm A2: TTD in PF using the QLQ-C30 Physical Functioning Scale

    Time frame: Up to 10 Years

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

  85. Arm A1 vs Arm B: TTD in PF using the QLQ-C30 Physical Functioning Scale

    Time frame: Up to 10 Years

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

  86. Arm A1 vs Arm C: TTD in PF using the QLQ-C30 Physical Functioning Scale

    Time frame: Up to 10 Years

    The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.

  87. Arm A1 vs Arm A2: Change from baseline in the remaining items and domains of the EORTC QLQ-C30

    Time frame: Up to 10 Years

    The EORTC QLQ-C30: A 30 items questionnaire to assess the quality of life of cancer patients on physical, emotional, cognitive, and social functions and symptoms. with a higher score indication worse quality of life.

  88. Arm A1 vs Arm B: Change from baseline in the remaining items and domains of the EORTC QLQ-C30

    Time frame: Up to 10 Years

    The EORTC QLQ-C30: A 30 items questionnaire to assess the quality of life of cancer patients on physical, emotional, cognitive, and social functions and symptoms. with a higher score indication worse quality of life.

  89. Arm A1 vs Arm C: Change from baseline in the remaining items and domains of the EORTC QLQ-C30

    Time frame: Up to 10 Years

    The EORTC QLQ-C30: A 30 items questionnaire to assess the quality of life of cancer patients on physical, emotional, cognitive, and social functions and symptoms. with a higher score indication worse quality of life.

  90. Arm A1 vs Arm A2: Change in Patient Global Impression of Change (PGIC) for General Lymphoma Symptoms

    Time frame: Up to 10 Years

    The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.

  91. Arm A1 vs Arm C: Change in PGIC for General Lymphoma Symptoms

    Time frame: Up to 10 Years

    The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.

  92. Arm A1 vs Arm A2: Change in Patient Global Impression of Severity (PGIS) for General Lymphoma Symptoms

    Time frame: Up to 10 Years

    The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity.

  93. Arm A1 vs Arm B: Change in PGIS for General Lymphoma Symptoms

    Time frame: Up to 10 Years

    The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity.

  94. Arm A1 vs Arm C: Change in PGIS for General Lymphoma Symptoms

    Time frame: Up to 10 Years

    The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

Genmab

Industry

Collaborators

  • AbbVie

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

Acronym: EPCORE™FL-2

Important dates

Study start
2024
Primary completion
2037
Study completion
2037
First posted
Jan 5, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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