Trial · NCT04680052
Outcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First | up to approximately 34 months | Follicular Lymphoma (FL) Full Analysis Set: all randomized participants with FL. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis. | months | MEDIAN |
| PRIMARY | FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to 2 years | FL Full Analysis Set. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set. | percent probability | NUMBER |
| SECONDARY | Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to approximately 34 months | Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis. | months | MEDIAN |
| SECONDARY | Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to 2 years | Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set. | percent probability | NUMBER |
| SECONDARY | FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria | up to approximately 34 months | FL FDG-avid Set: all randomized participants with FL and with a PET scan at Baseline with a resulting Deauville score of 4 or 5. Participants who did not have a post-baseline PET scan were considered to be not assessed, but were included in the analysis. The 95% confidence intervals were calculated using the Clopper-Pearson method. | percentage of participants | NUMBER |
| SECONDARY | FL Population: Overall Survival | up to approximately 34 months | FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis. | months | MEDIAN |
| SECONDARY | FL Population: Kaplan-Meier Estimates of Overall Survival | up to 2 years | FL Full Analysis Set. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set. | percent probability | NUMBER |
| SECONDARY | FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria | up to approximately 34 months | Overall FDG-avid Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Participants who did not have a post-baseline PET scan were considered to be not assessed, but were included in the analysis. The 95% confidence intervals were calculated using the Clopper-Pearson method. | percentage of participants | NUMBER |
| SECONDARY | FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment | up to approximately 34 months | FL MRD Blood-Evaluable Set: all participants in the Full Analysis Set with FL who received at least 1 dose of study treatment with identifiable clonality in blood samples at Cycle 1 Day 1. The 95% confidence intervals were calculated using the Clopper-Pearson method. Participants who did not have a post-baseline assessment were considered to be not assessed, but were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment | up to approximately 34 months | Overall MRD Blood-Evaluable Set. As pre-specified in the Statistical Analysis Plan, the MZL population was a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 95% confidence intervals were calculated using the Clopper-Pearson method. Participants who did not have a post-baseline assessment were considered to be not assessed, but were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment | up to approximately 34 months | FL Full Analysis Set. The 95% confidence intervals were calculated using the Clopper-Pearson method. | percentage of participants | NUMBER |
| SECONDARY | Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment | up to approximately 34 months | Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 95% confidence intervals were calculated using the Clopper-Pearson method. | percentage of participants | NUMBER |
| SECONDARY | FL Population: Duration of Response (DOR; the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | up to approximately 34 months | FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Only those participants who achieved an objective response (CR or PR) were analyzed. | months | MEDIAN |
| SECONDARY | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | up to 2 years | FL Full Analysis Set. Only those participants who achieved an objective response (CR or PR) were analyzed. Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set. | percent probability | NUMBER |
| SECONDARY | Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | up to approximately 34 months | Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Only participants who achieved an objective response (CR or PR) were analyzed. | months | MEDIAN |
| SECONDARY | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | up to 2 years | Overall Full Analysis Set. Per the SAP, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population (main analysis population). Participants who achieved CR or PR were analyzed. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set. | percent probability | NUMBER |
| SECONDARY | Overall Population: Overall Survival | up to approximately 34 months | Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis. | months | MEDIAN |
| SECONDARY | Overall Population: Kaplan-Meier Estimates of Overall Survival | up to 2 years | Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set. | percent probability | NUMBER |
| SECONDARY | FL Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to approximately 34 months | FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis. | months | MEDIAN |
| SECONDARY | FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to 2 years | FL Full Analysis Set. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set. | percent probability | NUMBER |
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.
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