First-Line Venetoclax Combinations in Chronic Lymphocytic Leukemia.
(2023) In New England Journal of Medicine 388(19). p.1739-1754- Abstract
- Background Randomized trials of venetoclax plus anti-CD20 antibodies as first-line treatment in fit patients (i.e., those with a low burden of coexisting conditions) with advanced chronic lymphocytic leukemia (CLL) have been lacking. Methods In a phase 3, open-label trial, we randomly assigned, in a 1:1:1:1 ratio, fit patients with CLL who did not have TP53 aberrations to receive six cycles of chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) or 12 cycles of venetoclax-rituximab, venetoclax-obinutuzumab, or venetoclax-obinutuzumab-ibrutinib. Ibrutinib was discontinued after two consecutive measurements of undetectable minimal residual disease or could be extended. The primary end points were undetectable... (More)
- Background Randomized trials of venetoclax plus anti-CD20 antibodies as first-line treatment in fit patients (i.e., those with a low burden of coexisting conditions) with advanced chronic lymphocytic leukemia (CLL) have been lacking. Methods In a phase 3, open-label trial, we randomly assigned, in a 1:1:1:1 ratio, fit patients with CLL who did not have TP53 aberrations to receive six cycles of chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) or 12 cycles of venetoclax-rituximab, venetoclax-obinutuzumab, or venetoclax-obinutuzumab-ibrutinib. Ibrutinib was discontinued after two consecutive measurements of undetectable minimal residual disease or could be extended. The primary end points were undetectable minimal residual disease (sensitivity, (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/42fbc9a8-25f1-4568-8e98-7281f9b05f0f
- author
- Eichhorst, B. ; Juliusson, Gunnar LU and Hallek, M
- author collaboration
- organization
- publishing date
- 2023
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Hematology/Oncology, Leukemia/Lymphoma, Treatments in Oncology, bendamustine, cyclophosphamide, fludarabine, ibrutinib, obinutuzumab, rituximab, venetoclax, aged, alanine aminotransferase level, anemia, Article, atrial fibrillation, blood, breast disease, cancer combination chemotherapy, chronic lymphatic leukemia, connective tissue disease, controlled study, death, diarrhea, disease exacerbation, drug efficacy, drug safety, drug withdrawal, faintness, febrile neutropenia, female, fever, first-line treatment, flow cytometry, genital system disease, human, human cell, hypersensitivity, hypertension, hypophosphatemia, infection, influenza, leukocyte, leukocyte count, leukopenia, major clinical study, male, minimal residual disease, multiple cycle treatment, musculoskeletal disease, neutropenia, neutrophil count, non melanoma skin cancer, open study, phase 3 clinical trial, platelet count, pneumonia, postoperative complication, progression free survival, prospective study, randomized controlled trial, side effect, skin disease, solid tumor, thrombocytopenia, treatment response, tumor lysis syndrome, upper respiratory tract infection, urinary tract infection
- in
- New England Journal of Medicine
- volume
- 388
- issue
- 19
- pages
- 16 pages
- publisher
- Massachusetts Medical Society
- external identifiers
-
- scopus:85160272522
- pmid:37163621
- ISSN
- 0028-4793
- DOI
- 10.1056/NEJMoa2213093
- language
- English
- LU publication?
- yes
- id
- 42fbc9a8-25f1-4568-8e98-7281f9b05f0f
- date added to LUP
- 2023-11-13 15:39:12
- date last changed
- 2023-11-14 03:00:04
@article{42fbc9a8-25f1-4568-8e98-7281f9b05f0f,
abstract = {{Background Randomized trials of venetoclax plus anti-CD20 antibodies as first-line treatment in fit patients (i.e., those with a low burden of coexisting conditions) with advanced chronic lymphocytic leukemia (CLL) have been lacking. Methods In a phase 3, open-label trial, we randomly assigned, in a 1:1:1:1 ratio, fit patients with CLL who did not have TP53 aberrations to receive six cycles of chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) or 12 cycles of venetoclax-rituximab, venetoclax-obinutuzumab, or venetoclax-obinutuzumab-ibrutinib. Ibrutinib was discontinued after two consecutive measurements of undetectable minimal residual disease or could be extended. The primary end points were undetectable minimal residual disease (sensitivity,}},
author = {{Eichhorst, B. and Juliusson, Gunnar and Hallek, M}},
issn = {{0028-4793}},
keywords = {{Hematology/Oncology; Leukemia/Lymphoma; Treatments in Oncology; bendamustine; cyclophosphamide; fludarabine; ibrutinib; obinutuzumab; rituximab; venetoclax; aged; alanine aminotransferase level; anemia; Article; atrial fibrillation; blood; breast disease; cancer combination chemotherapy; chronic lymphatic leukemia; connective tissue disease; controlled study; death; diarrhea; disease exacerbation; drug efficacy; drug safety; drug withdrawal; faintness; febrile neutropenia; female; fever; first-line treatment; flow cytometry; genital system disease; human; human cell; hypersensitivity; hypertension; hypophosphatemia; infection; influenza; leukocyte; leukocyte count; leukopenia; major clinical study; male; minimal residual disease; multiple cycle treatment; musculoskeletal disease; neutropenia; neutrophil count; non melanoma skin cancer; open study; phase 3 clinical trial; platelet count; pneumonia; postoperative complication; progression free survival; prospective study; randomized controlled trial; side effect; skin disease; solid tumor; thrombocytopenia; treatment response; tumor lysis syndrome; upper respiratory tract infection; urinary tract infection}},
language = {{eng}},
number = {{19}},
pages = {{1739--1754}},
publisher = {{Massachusetts Medical Society}},
series = {{New England Journal of Medicine}},
title = {{First-Line Venetoclax Combinations in Chronic Lymphocytic Leukemia.}},
url = {{http://dx.doi.org/10.1056/NEJMoa2213093}},
doi = {{10.1056/NEJMoa2213093}},
volume = {{388}},
year = {{2023}},
}