Trial · NCT05660967
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) rate | From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years | Percentage of participants achieving CR. Assessed by the Investigator per Lugano criteria |
| Secondary | Duration of response (DOR) | From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years | Defined as the time between date of first response to the date of first documented tumor progression or death (due to any cause) whichever occurs first |
| Secondary | Duration of complete response (DOCR) | From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years | Defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first |
| Secondary | Time to response (TTR) | From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 1 year | Defined as the time from first dose to first documentation of objective tumor response (CR or PR) |
| Secondary | Overall Response Rate (ORR) | From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years | Defined as the percentage of patients who achieve best overall response of complete response (CR) or partial response (PR) determined by Lugano criteria |
| Secondary | Progression-free survival (PFS) | From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years | Defined as the time from first dose to date of PD or death (due to any cause) whichever occurs first |
| Secondary | Time to next anti-lymphoma therapy (TTNT) | From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years | Defined as the time from first dose to administration of subsequent anti-lymphoma therapy |
| Secondary | Rate of minimal residual disease (MRD) negativity | From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years | Percentage of participants with at least 1 post-screening MRD negative result |
| Secondary | Overall survival (OS) | From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 3 years | Defined at the timeframe from first dose to death |
| Secondary | Incidence and severity of adverse events (AEs) | From screening until end of the safety follow-up period (60 days after last dose) | An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment |
| Secondary | Incidence of anti-drug antibodies (ADAs) to epcoritamab in plasma | From first dose until treatment discontinuation (assessed up to 12 months) | To evaluate immunogenicity |
| Secondary | Evaluate patient-reported outcomes (PROs) related to lymphoma symptoms | From cycle 1, day 1 until 90 days after last dose (each cycle is 28 days) | Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym). Scale from 0-168 obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life |
| Secondary | Epcoritamab plasma concentrations over time | From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months) |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05660967/registered