Trial · NCT04970901
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) | Day 1 to Day 21 of Cycle 1, where a cycle is 21 days | |
| Primary | Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) | Up to approximately 2 years for Arm C and 3 years for Arms E and F | Frequency and severity of TEAEs and treatment-emergent serious adverse events (TESAEs). TEAEs and TESAEs will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
| Primary | Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Delay | Up to approximately 1 year | |
| Primary | Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Interruption | Up to approximately 1 year | |
| Primary | Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Reduction | Up to approximately 1 year | |
| Primary | Number of Participants Who Experience a Clinically Significant Change from Baseline in Safety Laboratory Measurements | Baseline up to approximately 1 year | |
| Primary | Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Signs | Baseline up to approximately 1 year | |
| Primary | Number of Participants Who Experience a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status | Baseline up to approximately 1 year | ECOG performance status will be measured on a scale from grades 0-5, where a higher grade indicates a worse outcome. |
| Primary | Number of Participants Who Experience a Clinically Significant Change from Baseline in 12-Lead Electrocardiogram (ECG) Measurements | Baseline up to approximately 1 year | |
| Secondary | Complete Response Rate (CRR) | Up to approximately 2 years for Arm C and 3 years for Arms E and F | |
| Secondary | Overall Response Rate (ORR) | Up to approximately 2 years for Arm C and 3 years for Arms E and F | |
| Secondary | Duration of Response (DOR) | Up to approximately 2 years for Arm C and 3 years for Arms E and F | |
| Secondary | Progression-Free Survival (PFS) | Up to approximately 2 years for Arm C and 3 years for Arms E and F | |
| Secondary | Relapse-Free Survival (RFS) | Up to approximately 2 years for Arm C and 3 years for Arms E and F | |
| Secondary | Overall Survival (OS) | Up to approximately 2 years for Arm C and 3 years for Arms E and F | |
| Secondary | Average Concentration of Loncastuximab Tesirine | Day 1 to end of treatment (up to approximately 1 year) | |
| Secondary | Maximum Concentration (Cmax) of Loncastuximab Tesirine | Day 1 to end of treatment (up to approximately 1 year) | |
| Secondary | Time to Maximum Concentration (Tmax) of Loncastuximab Tesirine | Day 1 to end of treatment (up to approximately 1 year) | |
| Secondary | Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine | Day 1 to end of treatment (up to approximately 1 year) | |
| Secondary | Area Under the Concentration-Time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of Loncastuximab Tesirine | Day 1 to end of treatment (up to approximately 1 year) |
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/NCT04970901/registered