Trial · NCT05410418
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 With Complete Response (CR) as Best Response | Through completion of treatment (estimated to be 1 year) | CR determined by response to treatment by PET-CT at end of treatment per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Number of Participants With Complete Response (CR) | After Cycle 8 (each cycle is 21 days; estimated to be 6 months) | CR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Number of Participants With Partial Response (PR) | After Cycle 8 (each cycle is 21 days; estimated to be 6 months) | PR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Number of Participants With Partial Response (PR) as Best Response | Through completion of treatment (estimated to be 1 year) | PR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Overall Response Rate (ORR) as Measured by Number of Participants With Complete Response (CR) and Partial Response (PR) | After Cycle 8 (each cycle is 21 days; estimated to be 6 months) | CR and PR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Overall Response Rate (ORR) as Measured by Number of Participants With Complete Response (CR) and Partial Response (PR) | Through completion of treatment (estimated to be 1 year) | CR and PR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Number of Participants With Stable Disease (SD) | After Cycle 8 (each cycle is 21 days; estimated to be 6 months) | SD determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Number of Participants With Stable Disease (SD) as Best Response | Through completion of treatment (estimated to be 1 year) | SD determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Number of Participants With Progressive Disease (PD) | After Cycle 8 (each cycle is 21 days; estimated to be 6 months) | PD determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Number of Participants With Progressive Disease (PD) as Best Response | Through completion of treatment (estimated to be 1 year) | PD determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Number of Participants With Complete Response (CR) | After Cycle 2 (each cycle is 21 days; estimated to be 42 days) | CR determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Number of Participants With Partial Response (PR) | After Cycle 2 (each cycle is 21 days; estimated to be 42 days) | PR determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Overall Response Rate (ORR) as Measured by Number of Participants With Complete Response (CR) and Partial Response (PR) | After Cycle 2 (each cycle is 21 days; estimated to be 42 days) | CR and PR determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Number of Participants With Stable Disease (SD) | After Cycle 2 (each cycle is 21 days; estimated to be 42 days) | SD determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Number of Participants With Progressive Disease (PD) | After Cycle 2 (each cycle is 21 days; estimated to be 42 days) | PD determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. |
| Secondary | Time to First Response of Complete Response (CR) or Partial Response (PR) | Through completion of treatment (estimated to be 1 year) | Response determined by PET-CT per the Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. Response assessment is performed after cycle 2 (estimated to be day 42), after cycle 8 (estimated to be at 6 months), and at end of treatment (estimated to be 1 year). |
| Secondary | Time to First Complete Response (CR) | Through completion of treatment (estimated to be 1 year) | Response determined by PET-CT per the Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. Response assessment is performed after cycle 2 (estimated to be day 42), after cycle 8 (estimated to be at 6 months), and at end of treatment (estimated to be 1 year) |
| Secondary | Frequencies and Grades of Treatment-emergent Adverse Events (TEAEs) | Evaluated from start of treatment to 30 day follow-up after conclusion of treatment, study discontinuation/termination, or initiation of alternative lymphoma-directed therapy, whichever occurs first (estimated to be 1 year and 30 days). | |
| Secondary | Rate of Treatment Discontinuation Due to Treatment-emergent Adverse Events (TEAEs) | Evaluated from start of treatment to 30 day follow-up after conclusion of treatment, study discontinuation/termination, or initiation of alternative lymphoma-directed therapy, whichever occurs first (estimated to be 1 year and 30 days). | TEAEs are defined as adverse events that are possibly, probably, or definitely related to study treatment and occur on or after first dose of study treatment.. |
| Secondary | Percentage of Patients Requiring Any Tocilizumab Doses for Management of Cytokine Release Syndrome (CRS) | Up to approximately 1 year and 3 days | Tocilizumab is recommended for treatment of grade 2 CRS and required for grade 3 or 4 CRS. Tocilizumab should be administered by IV infusion for a maximum of 4 doses. |
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/NCT05410418/registered