Trial · NCT03336333
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 | Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR) | Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021) | PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the ICR per 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with small lymphocytic lymphoma (SLL). |
| Secondary | Cohort 1: Overall Response Rate (ORR) Between Treatment Groups as Determined by ICR | Up to 5 years | ORR in Cohort 1 is defined as the percentage of participants who achieve a complete response, complete response with incomplete bone marrow recovery, partial response, or partial response with lymphocytosis, determined by the ICR. |
| Secondary | Pooled Cohort 1/1a: Overall Response Rate (ORR) Between Treatment Groups | Up to 5 years | |
| Secondary | Cohort 1: Overall Survival (OS) Between Treatment Groups as Determined by the ICR | Up to 5 years | OS in Cohort 1 is defined as the time from randomization to the date of death due to any reason. |
| Secondary | Cohort 1: Duration of Response (DOR) Between Treatment Groups as Determined by the ICR | Up to 5 years | Duration of response in Cohort 1 determined using the iwCLL criteria with modification for treatment related lymphocytosis (in participants with CLL) and the Lugano Classification for non-Hodgkin lymphoma (NHL; in participants with SLL), is defined as the time from the date that criteria for response (ie, partial response with lymphocytosis \[PR-L\] or better) are first met to the date that disease progression is objectively documented or death, whichever occurs first. |
| Secondary | Pooled Cohort 1/1a: Duration of Response (DOR) Between Treatment Groups | Up to 5 years | |
| Secondary | Cohort 1: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA) | Up to 5 years | PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per iwCLL guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with SLL. |
| Secondary | Pooled Cohort 1/1a: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA) | Up to 5 years | |
| Secondary | Cohort 1: Patient-reported Outcomes as Assessed by the (European Quality Of Life 5D 5L) EQ-5D-5L Questionnaire | Up to 5 years | |
| Secondary | Cohort 1: Patient-reported Outcomes as Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Questionnaire. | Up to 5 years | |
| Secondary | Cohort 2: Overall Response Rate (ORR) | Up to 5 years | |
| Secondary | Cohort 2: Progression-free Survival (PFS) | Up to 5 years | |
| Secondary | Cohort 2: Duration of Response (DOR) | Up to 5 years | |
| Secondary | Cohort 3: Overall Response Rate (ORR) | Up to 5 years | |
| Secondary | Cohort 3: Progression-free Survival (PFS) | Up to 5 years | |
| Secondary | Cohort 3: Duration of Response (DOR) | Up to 5 years | |
| Secondary | Cohort 3: Rate of Undetectable Minimal Residual Disease (MRD4) | Up to 5 years | |
| Secondary | Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 5 years | |
| Secondary | Apparent Rate of Clearance of Zanubrutinib From Plasma (CL/F)CL/F | Predose up to 12 hours postdose | |
| Secondary | Cohort 1 Zanubrutinib Only Arms: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12) | Predose up to 12 hours postdose |
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/NCT03336333/registered