Trial · NCT05458297
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants with MCL (Cohort C), FL (Cohort D), and CLL (Cohort D) with ≥1 Adverse Event (AE) | Up to approximately 81 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL (Cohort C), FL (Cohort D), and CLL (Cohort D) who experienced an AE will be reported. |
| Primary | Percentage of Participants with MCL (Cohort C), FL (Cohort D), and CLL (Cohort D) who Discontinue from Study Therapy Due to AE | Up to approximately 81 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL (Cohort C), FL (Cohort D), and CLL (Cohort D) who discontinued study treatment due to an AE will be reported. |
| Primary | Percentage of Participants with MCL (Cohort C) who Experience a Dose-Limiting Toxicity (DLT) | Up to approximately 81 months | The Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 will be used to grade the severity of AEs. DLTs for participants with MCL (Cohort C) as assessed by investigator will be reported. |
| Primary | Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by Blinded Independent Central Review (BICR) in Participants with MCL (Cohort A), RT (Cohort B), and FL (Cohort D) | Up to approximately 81 months | ORR, defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano Response Criteria as assessed by BICR in Participants with MCL (Cohort A), RT (Cohort B), and FL (Cohort D) will be reported. |
| Primary | ORR per Lugano Response Criteria as Assessed by Investigator in Participants with MCL (Cohort C) | Up to approximately 81 months | ORR, defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano Response Criteria as assessed by investigator in Participants with MCL (Cohort C) will be reported. |
| Primary | ORR per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Investigator in Participants with CLL (Cohort D) | Up to approximately 81 months | ORR, defined as the percentage of participants who achieve a CR or PR per iwCLL criteria as assessed by investigator in participants with CLL (Cohort D) will be reported. |
| Secondary | Duration of Response (DOR) per Lugano Response Criteria as Assessed by BICR in Participants with MCL (Cohort A), RT (Cohort B), and FL (Cohort D) | Up to approximately 81 months | DOR, defined as the time from the first documented evidence of CR or PR per Lugano Response Criteria as assessed by BICR, until disease progression or death due to any cause, whichever occurs first, in Participants with MCL (Cohort A), RT (Cohort B), and FL (Cohort D) will be reported. |
| Secondary | DOR per Lugano Response Criteria as Assessed by Investigator in Participants with MCL (Cohort C) | Up to approximately 81 months | DOR, defined as the time from the first documented evidence of CR or PR per Lugano Response Criteria as assessed by investigator, until disease progression or death due to any cause, whichever occurs first, in participants with MCL (Cohort C) will be reported. |
| Secondary | DOR per iwCLL Criteria as Assessed by Investigator in Participants with CLL (Cohort D) | Up to approximately 81 months | DOR, defined as the time from the first documented evidence of CR or PR per iwCLL criteria as assessed by investigator, until disease progression or death due to any cause, whichever occurs first, in participants with CLL (Cohort D) will be reported. |
| Secondary | Percentage of Participants with ≥1 AE in Participants with MCL (Cohort A) and RT (Cohort B) | Up to approximately 81 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL (Cohort A) and RT (Cohort B) who experienced an AE will be reported. |
| Secondary | Percentage of Participants Discontinuing from Study Therapy Due to AE in Participants with MCL (Cohort A) and RT (Cohort B) | Up to approximately 81 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with MCL (Cohort A) and RT (Cohort B) who discontinued study treatment due to an AE will be reported. |
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/NCT05458297/registered