Trial · NCT05409066
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Best Overall Response (BOR) | Up to approximately 2 years and 3 months | BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC. |
| Primary | Progression-Free Survival (PFS) | Up to approximately 2 years and 3 months | PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first). |
| Secondary | Percentage of Participants Achieving CR | Up to approximately 5 years | Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy. |
| Secondary | Overall Survival (OS) | Up to approximately 8 years from randomization | Overall survival is defined as the duration from the date of randomization to the date of the participant's death. |
| Secondary | Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity | Up to approximately 5 years | MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy. |
| Secondary | Change in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) | Up to approximately 8 years | The objective of the FACT-Lym patient-reported outcome (PRO) is to address health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Like-type scale, with a higher score signifying a higher quality of life. |
| Secondary | PFS as Assessed by Investigator | Up to approximately 5 years | PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by investigator or death (whichever occurs first). |
| Secondary | Percentage of Participants Achieving BOR as Assessed by Investigator | Up to approximately 5 years | BOR is defined as CR PR, determined by Lugano criteria, as assessed by an investigator. |
| Secondary | Percentage of Participants Achieving CR as Assessed by Investigator | Up to approximately 5 years | Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the investigator prior to the initiation of subsequent anti-lymphoma therapy. |
| Secondary | Duration of Response (DOR) | Up to approximately 8 years | DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first. |
| Secondary | Duration of Complete Response (DOCR) | Up to approximately 8 years | DOR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first. |
| Secondary | Time to Progression (TTP) | Up to approximately 8 years | Time to progression is defined as the number of days from the date of study drug start to the date of the first documented disease progression or relapse. |
| Secondary | Time to Next Anti-Lymphoma Treatment (TTNLT) | Up to approximately 8 years | Time to next anti-lymphoma treatment is defined as the number of days from the date of the first documented disease progression or relapse to the date of next anti-lymphoma treatment. |
| Secondary | Percentage of Participants Achieving CR at the End of Treatment | Up to approximately 5 years | Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy. |
| Secondary | Time to Response (TTR) | Up to approximately 8 years | Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR. |
| Secondary | Time to Complete Response (TTCR) | Up to approximately 8 years | Time to complete response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR. |
| Secondary | Event-Free Survival (EFS) | Up to approximately 8 years | EFS is defined as the duration from randomization to disease progression determined by Lugano criteria as assessed by the investigator, initiation of any non-protocol-specified new anti-lymphoma therapy for any reason, or death (whichever occurs first). |
| Secondary | Time to next anti-lymphoma treatment (TTNLT) | Up to approximately 8 years | |
| Secondary | Change in Patient's Global Impression of Severity (PGIS) | Up to approximately 8 years | PGIS is a self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity. Participants rate their lymphoma symptoms severity as none, mild, moderate, severe, or very severe. |
| Secondary | Change in Patient's Global Impression of Change (PGIC) | Up to approximately 8 years | PGIS is a self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. |
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/NCT05409066/registered