MedPath

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

Registration Number
NCT06191744
Lead Sponsor
Genmab
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
1095
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm A1: Epcoritamab + Lenalidomide and Rituximab (R2)EpcoritamabParticipants will receive epcoritamab in combination with R2 (ER2), followed by epcoritamab during the 120 week treatment duration.
Arm A1: Epcoritamab + Lenalidomide and Rituximab (R2)RituximabParticipants will receive epcoritamab in combination with R2 (ER2), followed by epcoritamab during the 120 week treatment duration.
Arm A1: Epcoritamab + Lenalidomide and Rituximab (R2)LenalidomideParticipants will receive epcoritamab in combination with R2 (ER2), followed by epcoritamab during the 120 week treatment duration.
Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2)EpcoritamabParticipants will receive epcoritamab in combination with R2 (ER2), during the 24 week treatment duration.
Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2)RituximabParticipants will receive epcoritamab in combination with R2 (ER2), during the 24 week treatment duration.
Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2)LenalidomideParticipants will receive epcoritamab in combination with R2 (ER2), during the 24 week treatment duration.
Arm B: Chemoimmunotherapy (CIT) Option APrednisoneParticipants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) \[G-CHOP\]/ rituximab (R)-CHOP during the 120 week treatment duration.
Arm B: Chemoimmunotherapy (CIT) Option ARituximabParticipants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) \[G-CHOP\]/ rituximab (R)-CHOP during the 120 week treatment duration.
Arm B: Chemoimmunotherapy (CIT) Option ADoxorubicinParticipants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) \[G-CHOP\]/ rituximab (R)-CHOP during the 120 week treatment duration.
Arm B: Chemoimmunotherapy (CIT) Option AVincristineParticipants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) \[G-CHOP\]/ rituximab (R)-CHOP during the 120 week treatment duration.
Arm B: Chemoimmunotherapy (CIT) Option ACyclophosphamideParticipants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) \[G-CHOP\]/ rituximab (R)-CHOP during the 120 week treatment duration.
Arm B: Chemoimmunotherapy (CIT) Option AObinutuzumabParticipants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) \[G-CHOP\]/ rituximab (R)-CHOP during the 120 week treatment duration.
Arm B: Chemoimmunotherapy (CIT) Option BPrednisoneParticipants will receive CIT Option B (G and bendamustine (Benda) \[G-Benda\]/R-Benda during the 120 week treatment duration.
Arm B: Chemoimmunotherapy (CIT) Option BRituximabParticipants will receive CIT Option B (G and bendamustine (Benda) \[G-Benda\]/R-Benda during the 120 week treatment duration.
Arm B: Chemoimmunotherapy (CIT) Option BObinutuzumabParticipants will receive CIT Option B (G and bendamustine (Benda) \[G-Benda\]/R-Benda during the 120 week treatment duration.
Arm B: Chemoimmunotherapy (CIT) Option BBendamustineParticipants will receive CIT Option B (G and bendamustine (Benda) \[G-Benda\]/R-Benda during the 120 week treatment duration.
Arm C: Lenalidomide and Rituximab (R2)RituximabParticipants will receive lenalidomide and rituximab (R2) during the 120 week treatment duration.
Arm C: Lenalidomide and Rituximab (R2)LenalidomideParticipants will receive lenalidomide and rituximab (R2) during the 120 week treatment duration.
Primary Outcome Measures
NameTimeMethod
Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)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).

Arm A1 vs Arm B: Number of Participants with Progression-free survival (PFS)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 Outcome Measures
NameTimeMethod
Arm A1 vs Arm C: Rate of MRD NegativityUp 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.

Arm A1 vs Arm A2: Change from Baseline in PF According to EORTC QLQ-C30Up 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.

Arm A1 vs Arm C: Change from Baseline in PF According to EORTC QLQ-C30Up 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.

Arm A1 vs Arm A2: OSUp to 10 Years

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

Arm A1 vs Arm C: OSUp to 10 Years

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

Arm A1 vs Arm B: Percentage of Participants who Achieve CR30Up to 30 Months

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

Arm A1 vs Arm B: Number of Participants with PFSUp 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.

Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per IRCUp to 10 Years

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

Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per InvestigatorUp to 10 Years

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

Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per IRCUp to 10 Years

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

Arm A1 vs Arm A2: TTNT per IRCUp to 10 Years

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

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

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

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

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

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

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

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

Arm A1 vs Arm A2: Duration of Response (DOR) per IRCUp to 10 Years

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

Arm A1 vs Arm A2: DOR per InvestigatorUp to 10 Years

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

Arm A1 vs Arm B: DOR per IRCUp to 10 Years

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

Arm A1 vs Arm B: DOR per InvestigatorUp to 10 Years

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

Arm A1 vs Arm C: DOR per IRCUp to 10 Years

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

Arm A1 vs Arm C: DOR per InvestigatorUp to 10 Years

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

Arm A1 vs Arm A2: Duration of Complete Response (DOCR) per IRCUp to 10 Years

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

Arm A1 vs Arm A2: DOCR per InvestigatorUp to 10 Years

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

Arm A1 vs Arm B: DOCR per IRCUp to 10 Years

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

Arm A1 vs Arm B: DOCR per InvestigatorUp to 10 Years

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

Arm A1 vs Arm C: DOCR per IRCUp to 10 Years

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

Arm A1 vs Arm C: DOCR per InvestigatorUp to 10 Years

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

Arm A1 vs Arm A2: Time to Progression per InvestigatorUp to 10 Years

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

Arm A1 vs Arm B: Time to Progression per IRCUp to 10 Years

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

Arm A1 vs Arm B: Time to Progression per InvestigatorUp to 10 Years

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

Arm A1 vs Arm C: Time to Progression per IRCUp to 10 Years

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

Arm A1 vs Arm C: Time to Progression per InvestigatorUp to 10 Years

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

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

Arm A1 vs Arm B: Number of Participants with PFS2Up 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.

Arm A1 vs Arm C: Number of Participants with PFS2Up 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.

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

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

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

Arm A1 vs Arm A2: Change in Tolerability as Measured by The Functional Assessment of Cancer Therapy - General (FACT-G) Item GP5Up 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.

Arm A1 vs Arm B: Change in Tolerability as Measured by FACT-G Item GP5Up to 10 Years

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

Arm A1 vs Arm C: Change in Tolerability as Measured by FACT-GG Item GP5Up to 10 Years

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

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

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

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

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

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

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

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

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

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

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

Arm A1 vs Arm A2: Change from baseline in the remaining items and domains of the EORTC QLQ-C30Up 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.

Arm A1 vs Arm B: Change from baseline in the remaining items and domains of the EORTC QLQ-C30Up 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.

Arm A1 vs Arm C: Change from baseline in the remaining items and domains of the EORTC QLQ-C30Up 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.

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

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

Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per InvestigatorUp to 10 Years

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

Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per IRCUp to 10 Years

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

Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per InvestigatorUp to 10 Years

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

Arm A1 vs Arm C: TTNT per IRCUp to 10 Years

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

Arm A1 vs Arm C: TTNT per InvestigatorUp to 10 Years

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

Arm A1 vs Arm A2: Time to Progression per IRCUp to 10 Years

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

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

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

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

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

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

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

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

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

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

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

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

Arm A1 vs Arm A2: Time to Next Anti-lymphoma Therapy (TTNT) per InvestigatorUp to 10 Years

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

Arm A1 vs Arm A2: TTNT per InvestigatorUp to 10 Years

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

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

Arm A1 vs Arm B: TTNT per IRCUp to 10 Years

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

Arm A1 vs Arm B: TTNT per InvestigatorUp to 10 Years

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

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

Arm A1 vs Arm B: Overall Survival (OS)Up to 10 Years

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

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

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)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.

Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30Up to 30 Months

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

Arm A1 vs Arm C: Percentage of Participants who Achieve CR30Up to 30 Months

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

Arm A1 vs Arm A2: Number of Participants with PFSUp 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.

Arm A1 vs Arm C: Number of Participants with PFSUp 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.

Arm A1 vs Arm A2: Rate of MRD NegativityUp 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.

Trial Locations

Locations (220)

Hôpital Saint-Louis /ID# 260509

🇫🇷

Paris, France

Clinique Sainte-Anne /ID# 261528

🇫🇷

Strasbourg, France

Zhujiang Hospital of Southern Medical University /ID# 260558

🇨🇳

Guangzhou, Guangdong, China

HaEmek Medical Center /ID# 259936

🇮🇱

Afula, H_efa, Israel

Fondazione Policlinico Universitario Campus Bio-Medico /ID# 260891

🇮🇹

Roma, Italy

Taichung Veterans General Hospital /ID# 260361

🇨🇳

Taichung, Taiwan

Nanfang Hospital of Southern Medical University /ID# 260795

🇨🇳

Guangzhou, Guangdong, China

Sansum Clinic Research /ID# 261596

🇺🇸

Santa Barbara, California, United States

Rocky Mountain Cancer Centers - Boulder /ID# 261203

🇺🇸

Boulder, Colorado, United States

Christiana Care Health Service /ID# 261207

🇺🇸

Newark, Delaware, United States

Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445

🇺🇸

Jacksonville, Florida, United States

Advent Health /ID# 261578

🇺🇸

Orlando, Florida, United States

Orlando Health Cancer Institute /ID# 260983

🇺🇸

Orlando, Florida, United States

Beacon Cancer Care /ID# 260670

🇺🇸

Coeur d'Alene, Idaho, United States

Peninsula Private Hospital /ID# 259325

🇦🇺

Frankston, Victoria, Australia

Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 259814

🇺🇸

Chicago, Illinois, United States

Cancer Care Specialists Of Central Illinois /ID# 272464

🇺🇸

Decatur, Illinois, United States

Illinois Cancer Care, PC /ID# 261526

🇺🇸

Peoria, Illinois, United States

Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583

🇺🇸

Fort Wayne, Indiana, United States

University of Iowa Health Care /ID# 262132

🇺🇸

Des Moines, Iowa, United States

University of Louisville Hospital /ID# 260544

🇺🇸

Louisville, Kentucky, United States

Norton Cancer Institute - St. Matthews /ID# 261076

🇺🇸

Louisville, Kentucky, United States

New England Cancer Specialists - Westbrook /ID# 260672

🇺🇸

Westbrook, Maine, United States

University of Maryland, Baltimore /ID# 259538

🇺🇸

Baltimore, Maryland, United States

American Oncology Partners of Maryland /ID# 259476

🇺🇸

Bethesda, Maryland, United States

St. Luke's Hospital - Chesterfield /ID# 260489

🇺🇸

Chesterfield, Missouri, United States

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006

🇺🇸

Billings, Montana, United States

Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506

🇺🇸

Grand Island, Nebraska, United States

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 262505

🇺🇸

Omaha, Nebraska, United States

University of Nebraska Medical Center /ID# 261996

🇺🇸

Omaha, Nebraska, United States

University of New Mexico /ID# 261083

🇺🇸

Albuquerque, New Mexico, United States

Presbyterian Kaseman Hospital /ID# 262451

🇺🇸

Albuquerque, New Mexico, United States

Presbyterian Rust Medical Center /ID# 262447

🇺🇸

Rio Rancho, New Mexico, United States

New York Oncology Hematology - Albany Cancer Center /ID# 261814

🇺🇸

Albany, New York, United States

Icahn School of Medicine at Mount Sinai /ID# 259595

🇺🇸

New York, New York, United States

New York Oncology Hematology /ID# 270208

🇺🇸

Troy, New York, United States

Clinical Research Alliance, Inc. /ID# 261078

🇺🇸

Westbury, New York, United States

Novant Health Presbyterian Medical Center /ID# 259740

🇺🇸

Charlotte, North Carolina, United States

Fudan University Cancer Hospital /ID# 260564

🇨🇳

Shanghai, Shanghai, China

Novant Health Forsyth Medical Center /ID# 259741

🇺🇸

Winston Salem, North Carolina, United States

Oncology Hematology Care, Inc - Blue Ash /ID# 261204

🇺🇸

Cincinnati, Ohio, United States

Taylor Cancer Research Center /ID# 260488

🇺🇸

Maumee, Ohio, United States

Oncology Associates of Oregon, P.C. /ID# 261816

🇺🇸

Eugene, Oregon, United States

MUSC Hollings Cancer Center /ID# 259604

🇺🇸

Charleston, South Carolina, United States

Prisma Health /ID# 259602

🇺🇸

Greenville, South Carolina, United States

Texas Oncology - Austin Midtown /ID# 261208

🇺🇸

Austin, Texas, United States

Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 261206

🇺🇸

Dallas, Texas, United States

MD Anderson Cancer Center /ID# 260984

🇺🇸

Houston, Texas, United States

Oncology Consultants /ID# 268390

🇺🇸

Houston, Texas, United States

Joe Arrington Cancer Research /ID# 260382

🇺🇸

Lubbock, Texas, United States

Intermountain Healthcare LDS Hospital /ID# 259759

🇺🇸

Salt Lake City, Utah, United States

Virginia Cancer Specialists - Fairfax /ID# 261205

🇺🇸

Fairfax, Virginia, United States

Oncology and Hematology Associates of Southwest Virginia /ID# 261592

🇺🇸

Roanoke, Virginia, United States

Vista Oncology - East Olympia /ID# 261360

🇺🇸

Olympia, Washington, United States

Virginia Mason Hospital & Medical Center /ID# 260549

🇺🇸

Seattle, Washington, United States

Northwest Medical Specialties - Tacoma /ID# 262133

🇺🇸

Tacoma, Washington, United States

Royal Prince Alfred Hospital /ID# 259320

🇦🇺

Camperdown, New South Wales, Australia

Liverpool Hospital /ID# 259321

🇦🇺

Liverpool, New South Wales, Australia

Peter MacCallum Cancer Center /ID# 260431

🇦🇺

Melbourne, New South Wales, Australia

Westmead Hospital /ID# 261465

🇦🇺

Westmead, New South Wales, Australia

Townsville University Hospital /ID# 259323

🇦🇺

Douglas, Queensland, Australia

Royal Brisbane and Women's Hospital /ID# 259326

🇦🇺

Herston, Queensland, Australia

Princess Alexandra Hospital /ID# 259329

🇦🇺

Woolloongabba, Queensland, Australia

Fiona Stanley Hospital /ID# 259324

🇦🇺

Murdoch, Western Australia, Australia

Royal Perth Hospital /ID# 259319

🇦🇺

Perth, Western Australia, Australia

Algemeen Ziekenhuis klina /ID# 260324

🇧🇪

Brasschaat, Antwerpen, Belgium

Cliniques Universitaires UCL Saint-Luc /ID# 260311

🇧🇪

Bruxelles, Bruxelles-Capitale, Belgium

UZ Gent /ID# 260312

🇧🇪

Gent, Oost-Vlaanderen, Belgium

AZ-Delta /ID# 260313

🇧🇪

Roeselare, West-Vlaanderen, Belgium

Groupe Sante CHC - Clinique du MontLegia /ID# 260325

🇧🇪

Liege, Belgium

UMHAT Dr Georgi Stranski EAD /ID# 260763

🇧🇬

Pleven, Bulgaria

Acibadem City Clinic Tokuda University Hospital EAD /ID# 260685

🇧🇬

Sofia, Bulgaria

UMHAT Sveti Ivan Rilski /ID# 259277

🇧🇬

Sofia, Bulgaria

SHAT Hematologic Diseases /ID# 260457

🇧🇬

Sofia, Bulgaria

Centre Hospitalier de l'Université de Montréal (CHUM) /ID# 260617

🇨🇦

Montréal, Quebec, Canada

Peking University Third Hospital /ID# 259806

🇨🇳

Beijing, Beijing, China

The First Affiliated Hospital of Xiamen University /ID# 260014

🇨🇳

Xiamen, Fujian, China

Sun Yat-Sen University Cancer Center /ID# 260478

🇨🇳

Guangzhou, Guangdong, China

Shenzhen People's Hospital /ID# 260137

🇨🇳

Shenzhen, Guangdong, China

Affiliated Cancer Hospital of Guangxi Medical University /ID# 260537

🇨🇳

Nanning, Guangxi, China

People's Hospital of Henan Province /ID# 259619

🇨🇳

Zhengzhou, Henan, China

Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 259743

🇨🇳

Wuhan, Hubei, China

Hubei Cancer Hospital /ID# 260506

🇨🇳

Wuhan, Hubei, China

The First Affiliated Hospital of Soochow University /ID# 260507

🇨🇳

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University /ID# 260556

🇨🇳

Nanchang, Jiangxi, China

The First Hospital of China Medical University /ID# 260217

🇨🇳

Shenyang, Liaoning, China

Shandong Cancer Hospital /ID# 260808

🇨🇳

Jinan, Shandong, China

West China Hospital, Sichuan University /ID# 260015

🇨🇳

Chengdu, Sichuan, China

Tianjin Cancer Hospital /ID# 259807

🇨🇳

Tianjin, Tianjin, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259616

🇨🇳

Tianjin, Tianjin, China

The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 260644

🇨🇳

Urumqi, Xinjiang, China

Zhejiang Cancer hospital /ID# 259742

🇨🇳

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University /ID# 260566

🇨🇳

Wenzhou, Zhejiang, China

Clinical Hospital Dubrava /ID# 260452

🇭🇷

Zagreb, Grad Zagreb, Croatia

Klinicka bolnica Merkur /ID# 260393

🇭🇷

Zagreb, Grad Zagreb, Croatia

Klinicki bolnicki centar Sestre milosrdnice /ID# 260456

🇭🇷

Zagreb, Grad Zagreb, Croatia

Klinicki bolnicki centar Zagreb /ID# 260364

🇭🇷

Zagreb, Grad Zagreb, Croatia

Klinicki bolnicki centar Rijeka /ID# 260455

🇭🇷

Rijeka, Primorsko-goranska zupanija, Croatia

Klinicki Bolnicki Centar (KBC) Split /ID# 260454

🇭🇷

Split, Splitsko-dalmatinska zupanija, Croatia

Zadar General Hospital /ID# 260837

🇭🇷

Zadar, Croatia

Fakultní nemocnice Hradec Králové - Sokolská /ID# 260560

🇨🇿

Hradec Králové, Hradec Kralove, Czech Republic

Fakultni nemocnice Kralovske Vinohrady /ID# 260572

🇨🇿

Praha, Czech Republic

Regionshospitalet Godstrup /ID# 260778

🇩🇰

Herning, Midtjylland, Denmark

Roskilde Sygehus /ID# 260780

🇩🇰

Roskilde, Sjælland, Denmark

Odense University Hospital /ID# 260777

🇩🇰

Odense, Syddanmark, Denmark

Sygehus Lillebalt, Vejle /ID# 260781

🇩🇰

Vejle, Syddanmark, Denmark

Hopital Prive du Confluent /ID# 260596

🇫🇷

Nantes CEDEX 2, Loire-Atlantique, France

Centre Hospitalier D'Avignon /ID# 260511

🇫🇷

Avignon, Provence-Alpes-Cote-d Azur, France

HCL - Hopital Lyon Sud /ID# 260508

🇫🇷

Pierre Benite CEDEX, Rhone, France

Centre Hospitalier du Mans /ID# 260510

🇫🇷

Le Mans CEDEX 9, Sarthe, France

CHU de CAEN - Hopital de la Cote de Nacre /ID# 260875

🇫🇷

Caen, France

CH Libourne - Hopital Robert Boulin /ID# 261478

🇫🇷

Libourne, France

Städtisches Klinikum Karlsruhe /ID# 260348

🇩🇪

Karlsruhe, Baden-Wuerttemberg, Germany

Universitaetsklinikum Frankfurt /ID# 260388

🇩🇪

Frankfurt am Main, Hessen, Germany

Klinikum Kassel /ID# 260432

🇩🇪

Kassel, Hessen, Germany

St.-Antonius-Hospital /ID# 260520

🇩🇪

Eschweiler, Nordrhein-Westfalen, Germany

Klinikum Ludwigshafen /ID# 260688

🇩🇪

Ludwigshafen am Rhein, Rheinland-Pfalz, Germany

Otto-von-Guericke-Universitaet /ID# 260425

🇩🇪

Magdeburg, Germany

Olympion General Clinic /ID# 262395

🇬🇷

Patras, Achaia, Greece

General Hospital of Athens Laiko /ID# 259708

🇬🇷

Athens, Attiki, Greece

University General Hospital Attikon /ID# 260855

🇬🇷

Athens, Attiki, Greece

General University Hospital of Alexandroupolis /ID# 260858

🇬🇷

Alexandroupolis, Greece

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259709

🇬🇷

Athens, Greece

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 260051

🇭🇺

Gyor, Gyor-Moson-Sopron, Hungary

Tolna Varmegyei Balassa Janos Korhaz /ID# 260048

🇭🇺

Szekszard, Tolna, Hungary

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 260050

🇭🇺

Szombathely, Vas, Hungary

Orszagos Onkologiai Intezet /ID# 260052

🇭🇺

Budapest, Hungary

Soroka University Medical Center /ID# 259937

🇮🇱

Be'er Sheva, HaDarom, Israel

Meir Medical Center /ID# 259938

🇮🇱

Kfar Saba, HaMerkaz, Israel

The Chaim Sheba Medical Center /ID# 259934

🇮🇱

Ramat Gan, Tel-Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 259933

🇮🇱

Tel Aviv, Tel-Aviv, Israel

Hadassah /ID# 259935

🇮🇱

Jerusalem, Yerushalayim, Israel

Rabin Medical Center /ID# 268328

🇮🇱

Petah Tikva, Israel

Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 260889

🇮🇹

Candiolo, Torino, Italy

IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 260886

🇮🇹

Bologna, Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 260888

🇮🇹

Palermo, Italy

AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 260744

🇮🇹

Reggio Emilia, Italy

Fujita Health University Hospital /ID# 264679

🇯🇵

Toyoake, Aichi, Japan

Matsuyama Red Cross Hospital /ID# 266426

🇯🇵

Matsuyama-shi, Ehime, Japan

University of Fukui Hospital /ID# 265680

🇯🇵

Yoshida-gun, Fukui, Japan

National Hospital Organization Kyushu Cancer Center /ID# 265960

🇯🇵

Fukuoka-shi, Fukuoka, Japan

Kyushu University Hospital /ID# 267861

🇯🇵

Fukuoka-shi, Fukuoka, Japan

Fukushima Medical University Hospital /ID# 264994

🇯🇵

Fukushima-shi, Fukushima, Japan

Chugoku Central Hospital /ID# 266520

🇯🇵

Fukuyama, Hiroshima, Japan

Sapporo Medical University Hospital /ID# 265031

🇯🇵

Sapporo, Hokkaido, Japan

Kobe City Medical Center General Hospital /ID# 266379

🇯🇵

Kobe-shi, Hyogo, Japan

Hitachi General Hospital /ID# 265676

🇯🇵

Hitachi, Ibaraki, Japan

Kitasato University Hospital /ID# 264675

🇯🇵

Sagamihara-shi, Kanagawa, Japan

Kanagawa Cancer Center /ID# 265497

🇯🇵

Yokohama-shi, Kanagawa, Japan

Okayama University Hospital /ID# 267135

🇯🇵

Okayama-shi, Okayama, Japan

Kansai Medical University Hospital /ID# 266019

🇯🇵

Hirakata-shi, Osaka, Japan

Kindai University Hospital /ID# 265038

🇯🇵

Osakasayama-shi, Osaka, Japan

Tokyo Metropolitan Komagome Hospital /ID# 267692

🇯🇵

Bunkyo ku, Tokyo, Japan

The University of Tokyo Hospital /ID# 266422

🇯🇵

Bunkyo-ku, Tokyo, Japan

Yamaguchi University Hospital /ID# 265619

🇯🇵

Ube, Yamaguchi, Japan

University of Yamanashi Hospital /ID# 264677

🇯🇵

Chuo, Yamanashi, Japan

Aomori Prefectural Central Hospital /ID# 265692

🇯🇵

Aomori, Japan

Chiba Cancer Center /ID# 267316

🇯🇵

Chiba, Japan

Seoul National University Bundang Hospital /ID# 260009

🇰🇷

Seongnam-si, Gyeonggido, Korea, Republic of

Seoul National University Hospital /ID# 260007

🇰🇷

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Asan Medical Center /ID# 260010

🇰🇷

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Samsung Medical Center /ID# 260008

🇰🇷

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Bravis Ziekenhuis /ID# 259055

🇳🇱

Bergen op Zoom, Noord-Brabant, Netherlands

Elisabeth Tweesteden Ziekenhuis /ID# 261239

🇳🇱

Tilburg, Noord-Brabant, Netherlands

Olvg /Id# 259543

🇳🇱

Amsterdam, Noord-Holland, Netherlands

St. Antonius Ziekenhuis /ID# 259053

🇳🇱

Nieuwegein, Utrecht, Netherlands

HagaZiekenhuis /ID# 261220

🇳🇱

Den Haag, Zuid-Holland, Netherlands

Leids Universitair Medisch Centrum /ID# 259049

🇳🇱

Leiden, Zuid-Holland, Netherlands

Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 259052

🇳🇱

Rotterdam, Zuid-Holland, Netherlands

Rijnstate /ID# 261219

🇳🇱

Arnhem, Netherlands

Universitair Medisch Centrum Groningen /ID# 259051

🇳🇱

Groningen, Netherlands

Auckland City Hospital /ID# 259330

🇳🇿

Grafton, Auckland, New Zealand

North Shore Hospital /ID# 260824

🇳🇿

Takapuna, Auckland, New Zealand

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 260633

🇵🇱

Lodz, Lodzkie, Poland

Pratia MCM Krakow /ID# 260075

🇵🇱

Krakow, Malopolskie, Poland

Narodowy Instytut Onkologii im. M. Sklodowskiej /ID# 260861

🇵🇱

Warszawa, Mazowieckie, Poland

Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 260170

🇵🇱

Kielce, Swietokrzyskie, Poland

Fundacao Champalimaud /ID# 259652

🇵🇹

Lisbon, Lisboa, Portugal

Unidade Local de Saude de Gaia/Espinho, EPE /ID# 259655

🇵🇹

Vila Nova de Gaia, Porto, Portugal

Unidade Local de Saude de Santa Maria, EPE /ID# 259650

🇵🇹

Lisboa, Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 259649

🇵🇹

Porto, Portugal

Pan American Center for Oncology Trials, LLC /ID# 260265

🇵🇷

Rio Piedras, Puerto Rico

Auxilio Mutuo Cancer Center /ID# 260262

🇵🇷

San Juan, Puerto Rico

Fundeni Clinical Institute /ID# 260296

🇷🇴

Bucharest, Bucuresti, Romania

Institutul Oncologic Prof Dr I Chiricuta /ID# 259704

🇷🇴

Cluj Napoca, Cluj, Romania

Institutul Regional de Oncologie /ID# 259697

🇷🇴

Jassi, Iasi, Romania

Spitalul Clinic Coltea /ID# 259699

🇷🇴

Bucharest, Romania

Clinical Hospital Center Zvezdara /ID# 260900

🇷🇸

Belgrade, Beograd, Serbia

University Clinical Center Serbia /ID# 259271

🇷🇸

Belgrade, Beograd, Serbia

University Clinical Center Kragujevac /ID# 259274

🇷🇸

Kragujevac, Sumadijski okrug, Serbia

Institute for Oncology of Vojvodina /ID# 260223

🇷🇸

Sremska Kamenica, Vojvodina, Serbia

University Clinical Center Vojvodina /ID# 259272

🇷🇸

Novi Sad, Serbia

Narodny onkologicky ustav /ID# 260638

🇸🇰

Bratislava, Bratislavsky kraj, Slovakia

Univerzitna nemocnica Martin /ID# 260631

🇸🇰

Martin, Zilinsky kraj, Slovakia

Alberts Cellular Therapy /ID# 260514

🇿🇦

Pretoria, Gauteng, South Africa

Haemalife Inc. /ID# 260513

🇿🇦

Kuilsrivier, Western Cape, South Africa

Instituto Catalan de Oncologia (ICO) Badalona /ID# 260495

🇪🇸

Badalona, Barcelona, Spain

Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 261439

🇪🇸

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Marques de Valdecilla /ID# 260497

🇪🇸

Santander, Cantabria, Spain

Clinica Universidad de Navarra - Pamplona /ID# 260496

🇪🇸

Pamplona, Navarra, Spain

Hospital Universitario Vall d'Hebron /ID# 260490

🇪🇸

Barcelona, Spain

National Taiwan University Hospital /ID# 260341

🇨🇳

Taipei City, Taipei, Taiwan

Hospital Clinic de Barcelona /ID# 260492

🇪🇸

Barcelona, Spain

Hospital Santa Creu i Sant Pau /ID# 260498

🇪🇸

Barcelona, Spain

Hospital San Pedro de Alcantara /ID# 260502

🇪🇸

Caceres, Spain

CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 261512

🇪🇸

Madrid, Spain

MD Anderson Madrid /ID# 260500

🇪🇸

Madrid, Spain

Hospital Universitario de Salamanca /ID# 260491

🇪🇸

Salamanca, Spain

Sodra Alvsborgs sjukhus /ID# 261168

🇸🇪

Boras, Vastra Gotalands lan, Sweden

China Medical University Hospital /ID# 260357

🇨🇳

Taichung, Taiwan

National Cheng Kung University Hospital /ID# 260363

🇨🇳

Tainan, Taiwan

Ege Universitesi Tip Fakultesi /ID# 259803

🇹🇷

Izmir, Turkey

Kocaeli University Med Faculty /ID# 259717

🇹🇷

Kocaeli, Turkey

Ondokuz Mayis Universitesi /ID# 259713

🇹🇷

Samsun, Turkey

Derriford Hospital and the Royal Eye Infirmary /ID# 262671

🇬🇧

Plymouth, Devon, United Kingdom

Hammersmith Hospital /ID# 261124

🇬🇧

London, England, United Kingdom

Queen Alexandra Hospital /ID# 269708

🇬🇧

Portsmouth, Hampshire, United Kingdom

Leeds Teaching Hospitals NHS Trust /ID# 260466

🇬🇧

Leeds, West Yorkshire, United Kingdom

The Christie Hospital /ID# 260463

🇬🇧

Manchester, United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260792

🇬🇧

Newcastle upon Tyne, United Kingdom

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