Trial · NCT07191249
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 | Overall Response Rate-ORR Overall response rate (ORR) at the end of treatment (6 months) using the Lugano criteria | 6 months | ORR is defined as the proportion of patients who achieved Complete Response or Partial Response determined by Lugano 2014 criteria as assessed by investigators at 6 months after initiation of treatment and prior to the initiation of any subsequent anti-lymphoma therapy. Patients without post-baseline disease assessments will be considered non-responders. |
| Secondary | Progression Free Survival -PFS | up to 24 months after last treatment dose | PFS is defined as the time in months from the first dose of study drug to disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause. Surviving patients without disease progression will be censored at the time of the last adequate disease assessment. Surviving subjects without post-baseline disease assessment will be censored at the date of first dose of study drug. |
| Secondary | Duration of response -DOR | up to 24 months after last treatment dose | DOR is defined for patients who achieved Complete Response (CR) or Partial Response (PR) ('responders'), as the time in months from initial CR/PR to disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause. Surviving responders without radiographic disease progression will be censored at the time of the last adequate disease assessment |
| Secondary | Complete Response Rate - CRR - Lymphoma (FACT-Lym) subscale. | up to 24 months after last treatment dose | CRR is defined as the proportion of patients who achieved Complete Response, determined by Lugano 2014 criteria as assessed by the investigator. All responses of Complete Response after initiation of subsequent anti-lymphoma therapy will be excluded. Subjects without post-baseline disease assessments will be considered as not achieving Complete Response. |
| Secondary | Duration of Complete Response -DOCR | up to 24 months after last treatment dose | DOCR is defined for patients who achieved Complete Response, as the time in months from initial CR/PR to disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause. Surviving responders without radiographic disease progression will be censored at the time of the last adequate disease assessment. |
| Secondary | Time to Next Treatment -TTNT | up to 24 months after last treatment dose | TTNT is defined as the time from the date of the first dose of study drug to the start of new non-protocol-specified anti-lymphoma therapy or death due to disease progression. Surviving patients who were reported as not having started new non-protocol-specified anti-lymphoma therapy will be censored at the last known alive date to be free of non-protocol-specified anti-lymphoma therapy. Surviving patients without any post-baseline visit will be censored at the date of the first dose of study drug |
| Secondary | Overall Survival -OS | up to 24 months after last treatment dose | OS is defined as the time in months from the first dose of study drug to death from any cause. Patients who are still alive at the end of the study or at the time of the analyses (12 and 24 months after the first dose of study drug) will be censored at the last known alive date |
| Secondary | Statistical Analysis for Safety | from first dose through 90 days after administration of last dose | Incidence of adverse events (AEs) and abnormal laboratory test results - including all AEs, treatment-emergent AEs (TEAEs), Adverse drug reactions (ADRs), SAEs, AEs leading to discontinuation, and AEs leading to death. |
| Secondary | Health related quality of life | whole treatment period- 6 months | Health-related quality of life will be assessed using the FACT-Lym (Functional Assessment of Cancer Therapy - Lymphoma) questionnaire. |
| Other | Exploratory Biomarker Research Endpoints: Longitudinal measurement of ctDNA in the peripheral blood (PB), before and during treatment, at disease progression, at CR and one year after achievement of CR, as a biomarker for long-term remission | up to one year after achievement CR | Longitudinal measurement of ctDNA in the peripheral blood (PB), before and during treatment, at disease progression, at CR and one year after achievement of CR, as a biomarker for long-term remission; |
| Other | Exploratory Biomarker Research Endpoints: | up to year after achievement of CR | Evaluating the treatment-induced dynamics and molecular signatures of the non-tumor lymphocytic and myeloid compartments in peripheral blood, before and during treatment, at disease progression, at CR and one year after achievement of CR by performing consecutive flow cytometry, single cell RNA sequencing (scRNA-seq) and epigenetic studies, and correlation with outcome; |
| Other | Exploratory Biomarker Research Endpoints: | up to year after achievement of CR | Analyzing tumor microenvironment (TME) in lymph nodes pre-treatment at disease progression, at CR and one year after achievement of CR by performing scRNA-seq; |
| Other | Exploratory Biomarker Research Endpoints | 24 months after last treatment | Evaluating the association between patient's microbiome and response to treatment |
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/NCT07191249/registered