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Trial · NCT06045806

Registered outcomes19

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

ListOutcomeTime frameDescription
PrimaryProgression Free Survival (PFS)Up to approximately 50 months after the first participant is randomizedPFS as assessed by Independent Review Committee (IRC)
SecondaryOverall Survival (OS)Up to approximately 60 months after the last participant is randomized
SecondaryPercentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 monthsFrom randomization up to 60 months from randomization
SecondaryPercentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)From randomization up to 15 months from randomization
SecondaryEvent-Free Survival (EFS)Up to approximately 60 months after the last participant is randomized
SecondaryDuration of Response (DOR)Up to approximately 60 months after the last participant is randomized
SecondaryPercentage of Participants with Complete Response (CR)Up to approximately 60 months after the last participant is randomizedCR as assessed by IRC
SecondaryTime to Progression (TTP)Up to approximately 60 months after the last participant is randomizedProgression as assessed by IRC
SecondaryProgression post-next line of treatment (PFS2)Up to approximately 60 months after the last participant is randomized
SecondaryTime to Next Treatment (TTNT)Up to approximately 60 months after the last participant is randomized
SecondaryNumber of Participants Experiencing Adverse Events (AEs)Up to approximately 60 months after the last participant is randomized
SecondaryNumber of Participants Experiencing Adverse Events of Special Interest (AESI)Up to approximately 60 months after the last participant is randomized
SecondaryMaximum Observed Plasma Concentration (Cmax)Up to approximately 60 months after the last participant is randomized
SecondaryTime of Maximum Observed Plasma Concentration (Tmax)Up to approximately 60 months after the last participant is randomized
SecondaryArea Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])Up to 28 days post infusion
SecondaryTime of Last Measurable Observed Plasma Concentration (Tlast)Up to approximately 60 months after the last participant is randomized
SecondaryTime-to-Definitive DeteriorationUp to approximately 50 months after the first participant is randomizedTime-to-definitive deterioration based on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 global health status/quality of life subscale
SecondaryMean Change from Baseline in EORTC QLQ-C30 Selected SubscalesUp to approximately 50 months after the first participant is randomized
The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 will be assessed: * Global health status/quality of life * Physical Functioning * Fatigue * Pain
SecondaryMean Change from Baseline in EORTC QLQ-MY20 Selected SubscalesUp to approximately 50 months after the first participant is randomized
The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-MY20 will be assessed: * Disease symptoms * Side-effects of treatment

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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