Trial · NCT07197307
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best overall response rate (BORR) | 12 months after the start of study therapy | BORR defined as the proportion of patients with r/r DLBCL, HGBL and FL grade 3B who achieve a complete or partial remission as best response up to 12-months of study treatment according to the 2014 Lugano criteria. |
| Secondary | Progression-free survival (PFS) | 2 years after the start of study therapy | 2-year progression-free survival (PFS) with a 95% confidence interval. PFS is defined as time from the first dose of study drug until one of the following events occurs, whichever is first: Disease progression, Relapse or Death due to any cause. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment. |
| Secondary | Overall survival (OS) | 2 years after the start of study therapy | 2-year overall survival (OS) defined as the time from the first dose of study drug to death of any cause. Patients who have not experienced an event at the time of analysis will be censored at the last date known to be alive. |
| Secondary | Complete response (CR) rate | 12 months after the start of study therapy | Complete response (CR) rate measured as the number of complete remissions as best response (achieved up to 12 months) divided by the number of patients treated with at least one dose of study drug. |
| Secondary | Partial response (PR) rate | 12 months after the start of study therapy | Partial response (PR) rate measured as the number of partial remissions as best response (achieved up to 12 months) divided by the number of patients treated with at least one dose of study drug. |
| Secondary | Time to complete response | from the start of therapy to documentation of complete remission | Time to complete response measured as the time from the start of therapy to documentation of complete remission. |
| Secondary | Time to best response | 12 months after the start of study therapy | Time to best response (achieved up to 12 months) measured as the time from the start of therapy to documentation of the best tumor response according to type of response. |
| Secondary | Duration of response | from documentation of tumor response (complete or partial remission) to relapse or progressive disease | Duration of response measured as the time from documentation of tumor response (complete or partial remission) to relapse or progressive disease. |
| Secondary | Progression rate | 12 months after the start of study therapy | Progression rate measured as the number of progressions (observed up to 12 months) divided by the number of patients treated with at least one dose of study drug. |
| Secondary | Rate of relapse | From date of complete or partial remission until the date of relapse, assessed until the end of the study | Relapse rate measured as the number of relapses divided by the number of patients included with complete or partial remission. |
| Secondary | Biological characteristics of the lymphoma | Screening visit (day -28 to day -1); during therapy cycles of loncastuximab tesirine and epcoritamab; end of trial, or in case of relapse/progression, or subject discontinuation, whichever comes first. | Outcomes of the study will be evaluated according to biological characteristics of the lymphoma. |
| Secondary | Adverse Events (AEs) | AEs will be assessed at each study visit from start of the study until 150 days after the last administration of loncastuximab tesirine and/or epcoritamab (whichever is administered last). | AEs that occurred in the study. |
| Secondary | Serious Adverse Events (SAEs) | SAEs will be assessed at each study visit from start of the study until 150 days after the last administration of loncastuximab tesirine and/or epcoritamab (whichever is administered last). | SAEs that occurred in the study. |
| Secondary | Rate of treatment-related deaths | from start of the therapy to 2 months after the end of therapy | Rate of treatment-related deaths defined as the number of treatment-related deaths during therapy or up to 2 months after the end of therapy divided by the number of patients treated with at least one dose of study drug. |
| Secondary | Number and duration of treatment cycles and cumulative doses of loncastuximab tesirine and epcoritamab | At each therapy cycle from start of the study therapy until the last administration of loncastuximab tesirine and/or epcoritamab (whichever is administered last). | Number of treatment cycles received, duration of treatment cycles and cumulative doses of loncastuximab tesirine and epcoritamab. |
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/NCT07197307/registered