Trial · NCT07275216
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 metabolic response (CMR) to pembrolizumab and gemcitabine (P-G) | During/after cycles 1-8 of P-G (cycle length = 21 days), before initiation of salvage or maintenance therapy or non-protocol lymphoma therapy | Will be estimated by the proportion of response-evaluable patients achieving a best response of CMR, along with the 95% exact binomial confidence interval. |
| Secondary | CMR | During/after cycles 1-8 of P-G (cycle length = 21 days) or cycles 1-4 of pembrolizumab maintenance (cycle length = 42 days), before initiation of non-protocol lymphoma therapy | Will be estimated by the proportion of response-evaluable patients achieving a best response of CMR, along with the 95% exact binomial confidence interval. |
| Secondary | Overall response (OR) | During/after cycles 1-8 of P-G (cycle length = 21 days) or cycles 1-4 of pembrolizumab maintenance (cycle length = 42 days), before initiation of non-protocol lymphoma therapy | Will be estimated by the proportion of response-evaluable patients achieving a best response of CMR or partial metabolic response (PMR), along with the 95% exact binomial confidence interval. |
| Secondary | Progression-free survival (PFS) | From start of P-G treatment to time of disease relapse/progression or death, assessed up to 24 months | Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median value will be estimated when available. |
| Secondary | Duration of response (DOR) | From first achievement of CMR or PMR during/after cycles 1-8 of P-G (cycle length = 21 days) or cycles 1-4 of pembrolizumab maintenance (cycle length = 42 days) to disease relapse/progression or death, assessed up to 24 months | Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median value will be estimated when available. |
| Secondary | Overall survival (OS) | From start of P-G treatment to time of death, assessed up to 24 months | Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median value will be estimated when available. |
| Secondary | Incidence of adverse events | Up to 24 months | Toxicities will be coded and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version (v) 5.0. Observed toxicities of study therapy will be summarized by type (organ affected or laboratory determination such as absolute neutrophil count), severity, and attribution. |
| Secondary | CMR (for patients who receive salvage therapy) | During/after cycles 1-12 of pembrolizumab, brentuximab vedotin, and dacarbazine (P-BV-D) (cycle length = 21 days), before initiation of non-protocol lymphoma therapy | Will be estimated by the proportion of response-evaluable patients achieving a best response of CMR, along with the 95% exact binomial confidence interval. |
| Secondary | OR (for patients who receive salvage therapy) | During/after cycles 1-12 of P-BV-D (cycle length = 21 days), before initiation of non-protocol lymphoma therapy | Will be estimated by the proportion of response-evaluable patients achieving a best response of CMR or PMR, along with the 95% exact binomial confidence interval. |
| Secondary | PFS (for patients who receive salvage therapy) | From start of P-BV-D treatment to time of disease relapse/progression or death, assessed up to 24 months | Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median value will be estimated when available. |
| Secondary | DOR (for patients who receive salvage therapy) | From first achievement of CMR or PMR during/after cycles 1-12 of P-BV-D (cycle length = 21 days) to disease relapse/progression or death, assessed up to 24 months | Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median value will be estimated when available. |
| Secondary | OS (for patients who receive salvage therapy) | From start of P-BV-D treatment to time of death, assessed up to 24 months | Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median value will be estimated when available. |
| Secondary | Incidence of adverse events (for patients who receive salvage therapy) | Up to 24 months | Toxicities will be coded and graded using the NCI CTCAE v 5.0. Observed toxicities of study therapy will be summarized by type (organ affected or laboratory determination such as absolute neutrophil count), severity, and attribution. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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/NCT07275216/registered