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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,095
Subcutaneous (SC) Injection
Oral Tablet
Intravenous (IV) Infusion
Oral Capsule
IV Injection
IV Injection
IV Injection
IV Infusion
IV Infusion
Scripps Mercy Hospital /ID# 265393
San Diego, California, United States
RECRUITINGSansum Clinic Research /ID# 261596
Santa Barbara, California, United States
RECRUITINGRocky Mountain Cancer Centers - Boulder /ID# 261203
Boulder, Colorado, United States
RECRUITINGChristiana Care Health Service /ID# 261207
Newark, Delaware, United States
Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)
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).
Time frame: Up to 30 Months
Arm A1 vs Arm B: Number of Participants with Progression-free survival (PFS)
PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death of any cause.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate
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.
Time frame: Up to 10 Years
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)
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.
Time frame: 21 Weeks
Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30
CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 30 Months
Arm A1 vs Arm C: Percentage of Participants who Achieve CR30
CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 30 Months
Arm A1 vs Arm A2: Number of Participants with PFS
PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Number of Participants with PFS
PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Rate of MRD Negativity
MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Rate of MRD Negativity
MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Change from Baseline in PF According to EORTC QLQ-C30
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Change from Baseline in PF According to EORTC QLQ-C30
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: OS
OS is defined as the time from the date of randomization to the date of death of any cause.
Time frame: Up to 10 Years
Arm A1 vs Arm C: OS
OS is defined as the time from the date of randomization to the date of death of any cause.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30
CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 30 Months
Arm A1 vs Arm B: Percentage of Participants who Achieve CR30
CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 30 Months
Arm A1 vs Arm C: Percentage of Participants who Achieve CR30
CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 30 Months
Arm A1 vs Arm A2: Number of Participants with PFS
PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Number of Participants with PFS
PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Number of Participants with PFS
PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per IRC
CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Percentage of Participants with Change in CR Rate per Investigator
CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per IRC
CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Percentage of Participants with Change in CR Rate per Investigator
CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per IRC
CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Percentage of Participants with Change in CR Rate per Investigator
CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Number of Participants with Best Overall Response (BOR) per per Investigator
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Number of Participants with BOR per IRC
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Number of Participants with BOR per Investigator
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Number of Participants with BOR per IRC
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Number of Participants with BOR per Investigator
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Number of Participants with BOR per IRC
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Number of Participants with Event-free Survival (EFS) per IRC
EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Number of Participants with EFS per Investigator
EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Number of Participants with EFS per IRC
EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Number of Participants with EFS per Investigator
EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Number of Participants with EFS per IRC
EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Number of Participants with EFS per Investigator
EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Duration of Response (DOR) per IRC
DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: DOR per Investigator
DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm B: DOR per IRC
DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm B: DOR per Investigator
DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm C: DOR per IRC
DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm C: DOR per Investigator
DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Duration of Complete Response (DOCR) per IRC
DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: DOCR per Investigator
DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm B: DOCR per IRC
DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm B: DOCR per Investigator
DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm C: DOCR per IRC
DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm C: DOCR per Investigator
DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Time to Next Anti-lymphoma Therapy (TTNT) per Investigator
TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: TTNT per IRC
TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: TTNT per Investigator
TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.
Time frame: Up to 10 Years
Arm A1 vs Arm B: TTNT per IRC
TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.
Time frame: Up to 10 Years
Arm A1 vs Arm B: TTNT per Investigator
TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.
Time frame: Up to 10 Years
Arm A1 vs Arm C: TTNT per IRC
TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.
Time frame: Up to 10 Years
Arm A1 vs Arm C: TTNT per Investigator
TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Time to Progression per IRC
Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Time to Progression per Investigator
Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Time to Progression per IRC
Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Time to Progression per Investigator
Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Time to Progression per IRC
Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Time to Progression per Investigator
Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Number of Participants with Progression-free Survival After Subsequent Anti-Lymphoma Therapy (PFS2)
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Number of Participants with PFS2
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Number of Participants with PFS2
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Change in Tolerability as Measured by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Change in Tolerability as Measured by PRO-CTCAE
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Change in Tolerability as Measured by PRO-CTCAE
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Change in Tolerability as Measured by The Functional Assessment of Cancer Therapy - General (FACT-G) Item GP5
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Change in Tolerability as Measured by FACT-G Item GP5
The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Change in Tolerability as Measured by FACT-GG Item GP5
The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Change in Symptoms as Measured by The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Change in Symptoms as Measured by FACT-Lym
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Change in Symptoms as Measured by FACT-Lym
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Change in Quality of Life (QoL) as Measured by FACT-Lym
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Change in QoL as Measured by FACT-Lym
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Change in QoL as Measured by FACT-Lym
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Time-to-first PRO deterioration (TTD) in well-being using the lymphoma subscale (LymS) of FACT-Lym
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: TTD in well-being using LymS of FACT-Lym
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: TTD in well-being using LymS of FACT-Lym
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Change in QoL as Measured by 5-Level European Quality of Life (EuroQol)-5-dimension [EQ-5D-5L]
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Change in QoL as Measured by EQ-5D-5L
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Change in QoL as Measured by EQ-5D-5L
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: TTD in PF using the QLQ-C30 Physical Functioning Scale
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: TTD in PF using the QLQ-C30 Physical Functioning Scale
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: TTD in PF using the QLQ-C30 Physical Functioning Scale
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Change from baseline in the remaining items and domains of the EORTC QLQ-C30
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Change from baseline in the remaining items and domains of the EORTC QLQ-C30
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Change from baseline in the remaining items and domains of the EORTC QLQ-C30
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Change in Patient Global Impression of Change (PGIC) for General Lymphoma Symptoms
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Change in PGIC for General Lymphoma Symptoms
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.
Time frame: Up to 10 Years
Arm A1 vs Arm A2: Change in Patient Global Impression of Severity (PGIS) for General Lymphoma Symptoms
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.
Time frame: Up to 10 Years
Arm A1 vs Arm B: Change in PGIS for General Lymphoma Symptoms
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.
Time frame: Up to 10 Years
Arm A1 vs Arm C: Change in PGIS for General Lymphoma Symptoms
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.
Time frame: Up to 10 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445
Jacksonville, Florida, United States
RECRUITINGAdvent Health /ID# 261578
Orlando, Florida, United States
RECRUITINGOrlando Health Cancer Institute /ID# 260983
Orlando, Florida, United States
RECRUITINGMoffitt Cancer Center /ID# 259487
Tampa, Florida, United States
RECRUITINGBeacon Cancer Care /ID# 260670
Coeur d'Alene, Idaho, United States
RECRUITINGNorthwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 259814
Chicago, Illinois, United States
RECRUITING...and 254 more locations