A5066196706- Acute Myeloid Leukemia Research
- Chronic Lymphocytic Leukemia Research
- Chronic Myeloid Leukemia Treatments
- Lymphoma Diagnosis and Treatment
- Acute Lymphoblastic Leukemia research
- Hemoglobinopathies and Related Disorders
- Advanced Breast Cancer Therapies
- Multiple Myeloma Research and Treatments
- Myeloproliferative Neoplasms: Diagnosis and Treatment
- Immunodeficiency and Autoimmune Disorders
- Protein Degradation and Inhibitors
- Histone Deacetylase Inhibitors Research
- HIV/AIDS drug development and treatment
- Neutropenia and Cancer Infections
- Cell death mechanisms and regulation
- Cancer Genomics and Diagnostics
- Monoclonal and Polyclonal Antibodies Research
- PARP inhibition in cancer therapy
- Glioma Diagnosis and Treatment
- CAR-T cell therapy research
- Hematopoietic Stem Cell Transplantation
- DNA Repair Mechanisms
- Phagocytosis and Immune Regulation
- Epigenetics and DNA Methylation
- Lung Cancer Research Studies
AbbVie (United States)
2016-2025
Amsterdam University Medical Centers
2023
Rabin Medical Center
2023
Bristol-Myers Squibb (United States)
2023
Moores Cancer Center
2023
Institute of Hydrology of the Slovak Academy of Sciences
2023
Universitätsklinikum des Saarlandes
2018
AbbVie (Japan)
2014
Cincinnati Children's Hospital Medical Center
2014
National Cancer Institute
2014
We present a phase II, single-arm study evaluating 800 mg daily venetoclax, highly selective, oral small-molecule B-cell leukemia/lymphoma-2 (BCL2) inhibitor in patients with high-risk relapsed/refractory acute myelogenous leukemia (AML) or unfit for intensive chemotherapy. Responses were evaluated following revised International Working Group (IWG) criteria. The overall response rate was 19%; an additional 19% of demonstrated antileukemic activity not meeting IWG criteria (partial bone...
Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. An international phase Ib/II study evaluated the safety and preliminary efficacy of venetoclax, a selective B-cell leukemia/lymphoma-2 inhibitor, together low-dose cytarabine (LDAC) in older adults AML.Adults 60 years or previously untreated AML ineligible chemotherapy were enrolled. Prior myelodysplastic syndrome, including hypomethylating agents (HMA), was...
Bcl-2 is a critical regulator of apoptosis that overexpressed in the majority small cell lung cancers (SCLC). Nativoclax (ABT-263) potent and selective inhibitor Bcl-x(L). The primary objectives this phase IIa study included safety at recommended II dose preliminary, exploratory efficacy assessment patients with recurrent progressive SCLC after least one prior therapy.Thirty-nine received navitoclax 325 mg daily, following an initial lead-in 150 daily for 7 days. Study endpoints toxicity...
Purpose Venetoclax is an orally bioavailable B-cell lymphoma 2 inhibitor. US Food and Drug Administration European Medicines Agency approval for patients with 17p deleted relapsed/refractory chronic lymphocytic leukemia [del(17p) CLL] was based on results from 107 patients. An additional 51 were enrolled in a safety expansion cohort. Extended analysis of all patients, including the effect minimal residual disease (MRD) negativity outcome, now reported. Patients Methods Overall, 158 or...
In previous analyses of the MURANO study, fixed-duration venetoclax plus rituximab (VenR) resulted in improved progression-free survival (PFS) compared with bendamustine (BR) patients relapsed or refractory chronic lymphocytic leukemia (CLL). At 4-year follow-up, we report long-term outcomes, response to subsequent therapies, and predictive value molecular genetic characteristics.Patients CLL were randomly assigned 2 years (VenR for first six cycles) cycles BR. PFS, overall (OS),...
The FMS-related tyrosine kinase 3 (FLT3) inhibitor gilteritinib is standard therapy for relapsed/refractory FLT3-mutated (FLT3mut) acute myeloid leukemia (AML) but seldom reduces FLT3mut burden or induces sustained efficacy. Gilteritinib combines synergistically with the BCL-2 venetoclax in preclinical models of AML.This phase Ib open-label, dose-escalation/dose-expansion study (ClinicalTrials.gov identifier: NCT03625505) enrolled patients FLT3 wild-type and (escalation) (expansion) AML....
PURPOSE There is limited evidence on the clinical utility of monitoring measurable residual disease (MRD) in patients with acute myeloid leukemia treated lower-intensity therapy. Herein, we explored outcomes venetoclax and azacitidine who achieved composite complete remission (CRc; + incomplete hematologic recovery) MRD < 10 –3 VIALE-A trial. METHODS The included this report were azacitidine. Bone marrow aspirate samples for multiparametric flow cytometry assessments collected central...
Abstract Purpose: To evaluate efficacy and safety of venetoclax + azacitidine among treatment-naïve patients with IDH1/2-mutant (mut) acute myeloid leukemia (AML). Patients Methods: Data were pooled from enrolled in a phase III study (NCT02993523) that compared treated or placebo prior Ib (NCT02203773) where azacitidine. Enrolled ineligible for intensive therapy due to age ≥75 years and/or comorbidities. on received 400 mg orally (days 1–28) (75 mg/m2; days 1–7/28-day cycle). Results: In the...
The CLL14 study has established one-year fixed-duration treatment of venetoclax and obinutuzumab (Ven-Obi) for patients with previously untreated chronic lymphocytic leukemia. With all off at least three years, we report a detailed analysis minimal residual disease (MRD) kinetics long-term outcome treated in the study.Patients were randomly assigned to receive six cycles 12 or chlorambucil (Clb-Obi). Progression-free survival (PFS) was primary end point. Key secondary points included rates...
The MURANO trial (A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine in Participants Relapsed or Refractory Chronic Lymphocytic Leukemia [CLL]; ClinicalTrials.gov identifier #NCT02005471) reported superior progression-free survival (PFS) and overall (OS) with venetoclax-rituximab (VenR) vs bendamustine-rituximab (BR) relapsed/refractory (R/R) CLL. Patients were randomized 2 years VenR (n = 194; rituximab for first 6 months) months BR 195). Although...
To evaluate efficacy and safety of venetoclax + azacitidine in treatment-naïve patients with acute myeloid leukemia harboring poor-risk cytogenetics TP53mut or TP53wt.We analyzed data from a phase III study (NCT02993523) comparing (400 mg orally days 1-28) (75 mg/m2 1-7) placebo azacitidine, Ib (NCT02203773) azacitidine. Patients were ineligible for intensive therapy. TP53 status was centrally; cytogenetic studies performed locally.Patients (n = 127) receiving (TP53wt 50; 54) compared 56)...
Data on long-term outcomes and biological drivers associated with depth of remission after BCL2 inhibition by venetoclax in the treatment chronic lymphocytic leukemia (CLL) are limited. In this open-label parallel-group phase-3 study, 432 patients previously untreated CLL were randomized (1:1) to receive either 1-year venetoclax-obinutuzumab (Ven-Obi, 216 patients) or chlorambucil-Obi (Clb-Obi, therapy (NCT02242942). The primary endpoint was investigator-assessed progression-free survival...
Abstract Venetoclax‐azacitidine is approved for treatment of patients with newly diagnosed acute myeloid leukemia (AML) ineligible intensive chemotherapy based on the interim overall survival (OS) analysis VIALE‐A study (NCT02993523). Here, long‐term follow‐up presented to address benefit and outcomes venetoclax‐azacitidine. Patients AML who were randomized 2:1 receive venetoclax‐azacitidine or placebo‐azacitidine. OS was primary endpoint; complete remission with/without blood count recovery...
Abstract The European LeukemiaNet (ELN) acute myeloid leukemia (AML) genetic risk classification systems are based on response to intensive chemotherapy; their ability discriminate outcomes in older patients treated with venetoclax-azacitidine may be suboptimal. This pooled analysis of the phase 3 VIALE-A trial (NCT02993523) and 1b study (NCT02203773) examined prognostic stratification according 2017 2022 ELN classifications derived new molecular signatures differentiating...
BackgroundMost patients with chronic lymphocytic leukaemia progress after treatment or retreatment targeted therapy chemoimmunotherapy and have limited subsequent options. Response levels to the single-agent venetoclax in relapsed setting is unknown. We aimed assess activity without previous B-cell receptor-associated kinase inhibitor (BCRi) treatment.MethodsThis multicentre, open-label, single-arm, phase 3b trial (VENICE-1) assessed safety of monotherapy adults refractory leukaemia,...