Trial · NCT06191744
Registered outcomes96
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 96
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). |
| Primary | 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 | 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. |
| Secondary | Arm A1 vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate | 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. |
| Secondary | 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. |
| Secondary | Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30 | Up to 30 Months | CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC. |
| Secondary | Arm A1 vs Arm C: Percentage of Participants who Achieve CR30 | Up to 30 Months | CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC. |
| Secondary | Arm A1 vs Arm A2: Number of Participants with 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 | Arm A1 vs Arm C: Number of Participants with 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 | Arm A1 vs Arm A2: Rate of MRD Negativity | 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. |
| Secondary | Arm A1 vs Arm C: Rate of MRD Negativity | 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. |
| Secondary | Arm A1 vs Arm A2: Change from Baseline in PF According to EORTC QLQ-C30 | 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. |
| Secondary | Arm A1 vs Arm C: Change from Baseline in PF According to EORTC QLQ-C30 | 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. |
| Secondary | Arm A1 vs Arm A2: OS | Up to 10 Years | OS is defined as the time from the date of randomization to the date of death of any cause. |
| Secondary | Arm A1 vs Arm C: OS | Up to 10 Years | OS is defined as the time from the date of randomization to the date of death of any cause. |
| Secondary | Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30 | Up to 30 Months | CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator. |
| Secondary | Arm A1 vs Arm B: Percentage of Participants who Achieve CR30 | Up to 30 Months | CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator. |
| Secondary | Arm A1 vs Arm C: Percentage of Participants who Achieve CR30 | Up to 30 Months | CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator. |
| Secondary | Arm A1 vs Arm A2: Number of Participants with PFS | 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. |
| Secondary | Arm A1 vs Arm B: Number of Participants with PFS | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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