Trial reportClinical pharmacokinetics2017
Impact of Venetoclax Exposure on Clinical Efficacy and Safety in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia.
Trial report in Clinical pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- Population Pharmacokinetic Models of Venetoclax in Hematologic Malignancies: A Systematic Review.Drug design, development and therapy · 2024Pooled it
- Venetoclax alone or in combination with other regimens treatment achieve deep and sustained remission of relapsed/refractory chronic lymphocytic leukemia: a meta-analysis.Clinical and experimental medicine · 2022Pooled it
- Exposure-response relationships of venetoclax in combination with carfilzomib and dexamethasone in relapsed/refractory t(11;14) multiple myeloma patients.Investigational new drugs · 2024Trial
- Phase 1/2 study of venetoclax, a BCL-2 inhibitor, in Japanese patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma.International journal of hematology · 2021Trial
- Semimechanistic Modeling to Guide Venetoclax Coadministration with Ritonavir and Digoxin.Clinical and translational science · 2020Trial
- Bayesian Population Model of the Pharmacokinetics of Venetoclax in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results from the Phase III MURANO Study.Clinical pharmacokinetics · 2019Trial
- Analysis of interactions between posaconazole/voriconazole and venetoclax.Antimicrobial agents and chemotherapy · 2026Article
- Pharmacokinetics of venetoclax in a patient after whipple pancreaticoduodenectomy.Cancer chemotherapy and pharmacology · 2026Article
- Population Pharmacokinetic Analyses and Exposure-Efficacy Relationships of Venetoclax in Chinese Pediatric Patients with Hematological Malignancy in a Real-World Setting.Drug design, development and therapy · 2026Article
- Real-World Pharmacokinetic and Exposure-Response Characterization of Venetoclax in Chinese Patients with Hematological Malignancies.Drug design, development and therapy · 2026Article
- Phase Ib study of enzalutamide with venetoclax in patients with metastatic castration-resistant prostate cancer.Cancer chemotherapy and pharmacology · 2025Article
- Semi-mechanistic population PK/PD model to aid clinical understanding of myelodysplastic syndromes following treatment with Venetoclax and Azacitidine.CPT: pharmacometrics & systems pharmacology · 2025Article
- Article
- Exposure-response analyses of venetoclax combined with hypomethylating agents in myelodysplastic syndromes: a retrospective study.Frontiers in pharmacology · 2025Article
- Therapeutic Drug Monitoring: A New Hope for Individualised Treatment with Venetoclax.Current drug targets · 2025Review
- Triazole antifungal drug interactions-practical considerations for excellent prescribing.The Journal of antimicrobial chemotherapy · 2024Review
- Clinical pharmacokinetics and pharmacodynamics of venetoclax, a selective B-cell lymphoma-2 inhibitor.Clinical and translational science · 2024Review
- Article
- The Nanomechanical Properties of CLL Cells Are Linked to the Actin Cytoskeleton and Are a Potential Target of BTK Inhibitors.HemaSphere · 2023Article
- Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet.Clinical drug investigation · 2022Article
Corrections and comments
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Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVenetoclax is a selective, potent, first-in-class B-cell lymphoma-2 inhibitor that restores apoptosis in cancer cells and has demonstrated efficacy in a variety of hematological malignancies.
objectiveThe objective of this research was to characterize the relationship between venetoclax exposures and efficacy and safety in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
methodsA total of 272 and 338 patients from four clinical studies were pooled for the exposure-efficacy and exposure-safety analyses, respectively. Demographics, baseline disease characteristics, and select co-medications were evaluated for their impact on efficacy (lymphocytes, tumor size, objective response [OR]) and safety (neutropenia and infection).
resultsHigher venetoclax concentrations led to a more rapid decrease in lymphocyte counts and tumor size, which translated into patients more rapidly achieving OR. The 17p deletion somatic mutation was not identified, in any of the analyses, to affect the responsiveness of patients to venetoclax. Model-based simulations of lymphocyte counts and tumor size estimated an OR rate (ORR) of 84.8 % (95 % confidence interval 81.5-88.0 %) at a venetoclax dosage of 400 mg daily, with minimal increase in ORR at higher doses. The safety analyses of the adverse events (grade 3 or higher) of neutropenia and infection indicated that higher average venetoclax concentrations were not associated with an increase in adverse events.
conclusionsThe exposure-response analyses indicated that a venetoclax dosage regimen of 400 mg daily results in a high (>80 %) probability of achieving OR in R/R CLL/SLL patients, with minimal probability of increasing neutropenia or infection with higher exposures.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.