Trial reportAdvances in therapy2022
Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma.
Trial report in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02055820 (A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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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.
A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- Population Pharmacokinetic Models of Venetoclax in Hematologic Malignancies: A Systematic Review.Drug design, development and therapy · 2024Pooled it
- Pharmacokinetics of venetoclax in a patient after whipple pancreaticoduodenectomy.Cancer chemotherapy and pharmacology · 2026Article
- Real-World Pharmacokinetic and Exposure-Response Characterization of Venetoclax in Chinese Patients with Hematological Malignancies.Drug design, development and therapy · 2026Article
- Changes in cardiac parameters during venetoclax treatment.Haematologica · 2025Article
- A Population Pharmacokinetics Study of Venetoclax Concomitant with Voriconazole in Patients with Hematologic Malignancies.Drug design, development and therapy · 2025Article
- Exposure-response analyses of venetoclax combined with hypomethylating agents in myelodysplastic syndromes: a retrospective study.Frontiers in pharmacology · 2025Article
- Clinical pharmacokinetics and pharmacodynamics of venetoclax, a selective B-cell lymphoma-2 inhibitor.Clinical and translational science · 2024Review
- Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies.Advances in hematology · 2024Review
- Mechanisms of action of the BCL-2 inhibitor venetoclax in multiple myeloma: a literature review.Frontiers in pharmacology · 2023Review
- Current clinical landscape of oncolytic viruses as novel cancer immunotherapeutic and recent preclinical advancements.Frontiers in immunology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOutcomes remain poor in patients with diffuse large B cell lymphoma (DLBCL) who overexpress BCL-2 protein. We present population pharmacokinetics (PopPK) and exposure-response (ER) analyses for venetoclax (a selective BCL-2 inhibitor) administered with rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with relapsed/refractory (R/R) and previously untreated (1L) non-Hodgkin lymphoma (NHL) from the phase 1b/2 CAVALLI study, to confirm dose selection for future studies.
methodsAnalyses included 216 patients with R/R or 1L NHL treated for eight 21-day cycles with 400-800 mg venetoclax (cycle 1: days 4-10; cycles 2-8: days 1-10) in combination with R for eight cycles and CHOP for 6-8 cycles. A legacy PopPK model for venetoclax was used to describe the observed data and provide post hoc PK parameters. Venetoclax steady-state exposure (AUC
resultsThere was no significant association between venetoclax AUC
conclusionsThe PopPK and ER analyses, in addition to the positive benefit-risk observed in the clinical data, support the selection of 800 mg venetoclax given with R-CHOP for future studies in BCL-2-immunohistochemistry-positive patients with 1L DLBCL.
trial registrationClinicalTrials.gov Identifier NCT02055820.
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