Trial · NCT06453044
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of grade 3 or higher adverse events (AEs) | Up to completion of first 2 cycles of treatment - each cycle is 28 days | Unacceptable toxicity will be defined as events occurring during the first 2 cycles of treatment that is at least possibly related to study treatment. Observed toxicities will be summarized by type, severity, and attribution. |
| Primary | Complete response (CR) rate | Up to 36 months after last dose of protocol therapy | CR rate will be defined as the proportion of response-evaluable participants that achieve a best response of CR after the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy. CR rate will be estimated along with the 95% exact binomial confidence interval. |
| Secondary | Incidence of AEs | Up to 30 days from last dose of protocol therapy | AEs will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Cytokine release syndrome (CRS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading Criteria. Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS) will be graded according to the ASTCT ICANS Consensus Grading Criteria. Observed toxicities will be summarized by type, severity, and attribution. |
| Secondary | Overall response rate (ORR) | Up to 36 months after last dose of protocol therapy | ORR will be defined as the proportion of response-evaluable participants that achieve a best response of CR or partial response (PR) after the start of protocol therapy and prior to disease progression and/or start of other anti-lymphoma therapy. ORR will be estimated along with the 95% exact binomial confidence interval. |
| Secondary | Time to first CR | At start of protocol therapy to CR up to 36 months after last dose of protocol therapy | Time to first CR will be defined as the time from start of protocol therapy until the time the patients first achieve CR. Time for first CR will be summarized by descriptive statistics. |
| Secondary | Time to best response | At start of protocol therapy to first best response up to 36 months after last dose of protocol therapy | Time to best response will be defined as the time from start of protocol therapy until the time the patients achieve first best response (CR or PR). Time to best response will be summarized by descriptive statistics. |
| Secondary | Duration of response (DOR) | At first PR or CR to progression or death up to 36 months after last dose of protocol therapy | DOR will be defined as the time from first achievement of PR or CR to time of progression or death, whichever is earlier. DOR will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. The 95% confidence interval will be constructed based on log-log transformation. Median DOR will be estimated when available. |
| Secondary | Duration of response among CR (DORC) | At CR up to 36 months after last dose of protocol therapy | DORC will be limited to patients who achieve a best response of CR. DORC will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. The 95% confidence interval will be constructed based on log-log transformation. |
| Secondary | Progression-free survival (PFS) | At start of protocol treatment to disease relapse/progression or death up to 36 months after last dose of protocol therapy | PFS will be defined as the duration of time from start of protocol treatment to time of disease relapse or progression to death due to any cause, whichever occurs earlier. PFS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. The 95% confidence interval will be constructed based on log-log transformation. Median PFS will be estimated when available. |
| Secondary | Overall survival (OS) | At start of protocol treatment to death up to 36 months after last dose of protocol therapy | OS will be defined as the duration of time from start of protocol treatment to time of death due to any cause.OS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. The 95% confidence interval will be constructed based on log-log transformation. Median OS will be estimated when available. |
| Secondary | Patient reported quality of life (QOL) | At baseline and up to 24 months of follow-up | Patient reported QOL will be assessed using the European Quality of Life Five Dimension Five Level scale. Changes in QOL measures will be summarized by each timepoint and longitudinally. |
| Secondary | Use of tocilizumab | Up to 36 months after last dose of protocol therapy | Use of tocilizumab will be defined as the need to administer tocilizumab. Use of tocilizumab for CRS will be summarized by descriptive statistics. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06453044/registered