Trial · NCT06014489
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetic equivalence of cobicistat boosted venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2).venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2). | 6-8 months | run-in phase |
| Primary | Overall survival (OS). | 48 months | extension phase |
| Secondary | Venetoclax and cobicistat CL, Cmax, Tmax, Cmin and AUC0-24. | 6-8 months | run-in phase |
| Secondary | Complete remission (CR) rate defined as CR as best response during or at completion of the treatment, as determined by the Investigator, based on the European LeukemiaNet (ELN2022) recommended response criteria (see Appendix B). | 48 months | extension phase |
| Secondary | CR with incomplete hematologic recovery (CRi) rate, based on the European LeukemiaNet (ELN2022) recommended response criteria (see Appendix B). | 48 months | extension phase |
| Secondary | CR and CR with incomplete hematologic recovery (CRi) rate, based on the European LeukemiaNet (ELN2022) recommended response criteria (see Appendix B). | 48 months | extension phase |
| Secondary | CR with partial hematologic recovery (CRh) rate, based on ELN 2022 recommendations. | 48 months | extension phase |
| Secondary | CR and CR with partial hematologic recovery (CRh) rate, based on ELN 2022 recommendations. | 48 months | extension phase |
| Secondary | CR or CR/CRi or CR/CRh without minimal residual disease (flow and or molecular) (CRMRD- or CR/CRiMRD- or CR/CRhMRD-). | 48 months | extension phase |
| Secondary | Morphologic leukemia-free state (MLFS) rate, based on ELN2022 recommendations. | 48 months | extension phase |
| Secondary | Event free survival (EFS). | 48 months | extension phase |
| Secondary | Relapse-free survival (RFS). | 48 months | extension phase |
| Secondary | Incidence and severity of adverse events according to CTCAE version 5.0. | 48 months | extension phase |
| Secondary | Early (30-day and 60-day) mortality (in general, non-leukemic). | 48 months | extension phase |
| Secondary | Time to next cycle, defined as the time from the start of the cycle until the start of the next cycle. | 48 months | extension phase |
| Secondary | OS of AZA/VEN/COBI treated patients in comparison with a real-world data cohort treated during the same time period and monitored by the Dutch Cancer registry. | 48 months | extension phase |
| Secondary | Prognostic/predictive impact of disease-associated genetic changes at diagnosis. | 48 months | extension phase |
| Secondary | Relapse-associated genetic changes (determined at relapse). The average relative dose intensity will be computed and given by categories. The same will be done for treatment deviation. | 48 months | extension phase |
| Secondary | Clonal evolution during treatment. | 48 months | extension phase |
| Secondary | Exposure-response and exposure-toxicity relation of venetoclax in patients with AML. | 48 months | extension phase |
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
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GET https://conductscience.org/api/trials/v1/NCT06014489/registered