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Trial · NCT06313996

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProgression-free survival (PFS)Up to 5 years from the last participant randomizedDefined as the time from randomization to death due to any cause or progressive disease (PD) per independent review committee (IRC) assessment using the Lugano 2014 Criteria, whichever occurs first
SecondaryComplete response (CR)Up to 5 years from the last participant randomizedDefined as participants achieving a complete response per IRC assessment using the Lugano 2014 Criteria
SecondaryOverall survival (OS)Up to approximately 7 yearsDefined as the time from randomization to death due to any cause
SecondaryOverall response (OR)Up to 5 years from the last participant randomizedDefined as participants achieving a response (CR or partial response (PR)) per IRC assessment using the Lugano 2014 Criteria
SecondaryDuration of response (DOR)Up to 5 years from the last participant randomizedDefined as the time from first response (CR or PR) per IRC assessment using the Lugano 2014 Criteria to PD or death due to any cause, whichever occurs first
SecondaryEvent-free survival (EFS)Up to 5 years from the last participant randomized
Defined as the time from randomization to the first documentation of progressive disease (PD) per IRC assessed using the Lugano 2014 Criteria start of new anti-cancer therapy, or death due to any cause, whichever occurs first
SecondaryTime to next anti-cancer therapy (TTNLT)Up to 5 years from the last participant randomizedDefined as time from randomization to start of new anti-cancer therapy or death due to any cause, whichever occurs first
SecondaryPFS rateUp to 5 years from the last participant randomized
SecondaryEFS rateUp to 5 years from the last participant randomized
SecondaryOS rateUp to approximately 7 years
SecondaryProgression-free survival on the next line of treatment (PFS-2)Up to 5 years from the last participant randomizedDefined as the time from randomization to death from any cause or tumor progression on next line treatment per Investigator assessment, whichever occurs first
SecondaryNumber of participants with adverse events (AEs)Up to 5 years from the last participant randomized
SecondaryNumber of participants with adverse event of special interest (AESIs)Up to 5 years from the last participant randomized
SecondaryNumber of participants with serious adverse events (SAEs)Up to 5 years from the last participant randomized
SecondaryNumber of participants with laboratory abnormalitiesUp to 5 years from the last participant randomized
SecondaryFrequency and length of hospitalizationsUp to 5 years from the last participant randomized
SecondaryNumber of participants with intensive care unit (ICU) inpatient daysUp to 5 years from the last participant randomized
SecondaryNumber of participants with non-ICU inpatient daysUp to 5 years from the last participant randomized
SecondaryMean change from baseline in key health-related quality of life (HRQoL) domains.Up to 5 years from the last participant randomized
Key HRQoL Domains: Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20)
SecondaryTime to meaningful improvement/deterioration in key HRQoL domains.Up to 5 years from the last participant randomized
Key HRQoL Domains: Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20)

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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