Registered outcomes11

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

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	PFS-INV	Time from date of randomization until Progressive Disease or death from any cause. In this trial, the primary endpoint is PFS as assessed by the investigator (up to 43 months)	Progression-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma
Secondary	EFS-INV	From randomization until the first occurrence of disease progression or relapse as assessed by the INV using, start of new anti-lymphoma treatment or death from any cause, whichever occurs first (up to 43 months)	Event-Free Survival as assessed by the investigator using the Lugano Response Criteria for Malignant Lymphoma
Secondary	OS	From randomization until the date of death from any cause (up to 62 months)	Overall Survival
Secondary	Metabolic PET-negative CR-rate at EOT by BIRC	End of treatment, 4-8 weeks after last dose	Metabolic PET-negative CR rate defined as the proportion of patients who achieved metabolic PET-negative CR as per Lugano 2014 criteria based on PET/CTs performed at the end of the treatment by BIRC
Secondary	Metabolic PET-negative CR-rate at EOT by INV	End of treatment, 4-8 weeks after last dose	Metabolic PET-negative CR rate defined as the proportion of patients who achieved metabolic PET-negative CR as per Lugano 2014 criteria based on PET/CTs performed at the end of the treatment by the investigator
Secondary	ORR as per INV at EOT	6 ± 2 weeks after End of Treatment	Overall response rate defined as the proportion of patients with CR or PR as per Lugano 2014 criteria based on assessment at the end of the treatment by the INV
Secondary	Time to next anti-lymphoma treatment (TTNT)	From randomization date to start of next anti-lymphoma therapy (for any reason including disease progression, treatment toxicity, and patient preference) or death due to any cause, whatever comes first (up to 43 months)	TTNT is defined as the time from randomization date to start of next anti-lymphoma therapy (for any reason including disease progression, treatment toxicity, and patient preference) or death due to any cause, whatever comes first.
Secondary	Duration of Complete Response (CR) as assessed by the investigator	From the date of the first occurrence of a documented CR, to the date of progression, relapse, or death from any cause, whichever is earlier (up to 43 months)	Duration of CR is defined as the time from the date of the first occurrence of a documented CR, to the date of progression, relapse, or death from any cause, whichever is earlier for the subgroup of patients with a Best Overall Response (BOR) of CR.
Secondary	EFS at 3 years	36 months after randomization	Event-Free Survival as assessed by the investigator
Secondary	PFS at 3 years	36 months after randomization	Progression-Free Survival as assessed by the investigator
Secondary	OS at 3 years	36 months after randomization	Overall Survival

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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