Risk-adapted, ofatumumab-based chemoimmunotherapy and consolidation in treatment-naïve chronic lymphocytic leukemia: a phase 2 study.

Antibodies, Monoclonal, Humanized / therapeutic use Antineoplastic Combined Chemotherapy Protocols / adverse effects Humans Immunotherapy Leukemia, Lymphocytic, Chronic, B-Cell / diagnosis Treatment Outcome
Chronic lymphocytic leukemia chemoimmunotherapy minimal residual disease ofatumumab trogocytosis

Journal

Leukemia & lymphoma
ISSN: 1029-2403
Titre abrégé: Leuk Lymphoma
Pays: United States
ID NLM: 9007422

Informations de publication

Date de publication:
08 2021
Historique:
pubmed: 4 3 2021
medline: 17 8 2021
entrez: 3 3 2021
Statut: ppublish

Résumé

High-risk cytogenetics and minimal residual disease (MRD) after chemoimmunotherapy (CIT) predict unfavorable outcome in chronic lymphocytic leukemia (CLL). This phase 2 study investigated risk-adapted CIT in treatment-naïve CLL (NCT01145209). Patients with high-risk cytogenetics received induction with fludarabine, cyclophosphamide, and ofatumumab. Those without high-risk cytogenetics received fludarabine and ofatumumab. After induction, MRD positive (MRD+) patients received 4 doses of ofatumumab consolidation. MRD negative (MRD-) patients had no intervention. Of 28 evaluable for response, all responded to induction and 10 (36%) achieved MRD-. Two-year progression-free survival (PFS) was 71.4% (CI

Identifiants

DOI: 10.1080/10428194.2021.1888379 PMID: 33653216 PMC: PMC9250410
pubmed: 33653216
doi: 10.1080/10428194.2021.1888379
pmc: PMC9250410
mid: NIHMS1814686
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
ofatumumab M95KG522R0

Banques de données

ClinicalTrials.gov
['NCT01145209']

Types de publication

Clinical Trial, Phase II Journal Article Research Support, N.I.H., Intramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1816-1827

Subventions

Organisme : Intramural NIH HHS
ID : ZIA HL006070
Pays : United States

Références

Clin Cancer Res. 2016 Jan 1;22(1):86-95
pubmed: 26283682
J Exp Med. 2006 Mar 20;203(3):743-53
pubmed: 16520392
J Clin Oncol. 2020 Nov 1;38(31):3626-3637
pubmed: 32795224
J Clin Oncol. 2012 Mar 20;30(9):980-8
pubmed: 22331940
Blood. 2008 Jun 15;111(12):5446-56
pubmed: 18216293
Haematologica. 2020 Jan 30;105(11):2671-2674
pubmed: 33131259
J Clin Oncol. 2011 Apr 1;29(10):1349-55
pubmed: 21321292
Blood. 2017 May 11;129(19):2636-2644
pubmed: 28288980
Cancer. 2009 Jan 15;115(2):373-80
pubmed: 19117034
N Engl J Med. 2017 Oct 5;377(14):1331-1344
pubmed: 28976863
J Immunol. 2011 Sep 15;187(6):3438-47
pubmed: 21841127
Leuk Lymphoma. 2015 Jun;56(6):1643-50
pubmed: 25308294
Leukemia. 2015 Jul;29(7):1602-4
pubmed: 25634683
Haematologica. 2010 Feb;95(2):329-32
pubmed: 19679883
Mol Pharmacol. 2014 Nov;86(5):485-91
pubmed: 24944188
Cytometry B Clin Cytom. 2011 Mar;80(2):83-90
pubmed: 20872890
Lancet. 2010 Oct 2;376(9747):1164-74
pubmed: 20888994
N Engl J Med. 2018 Dec 27;379(26):2517-2528
pubmed: 30501481
Blood. 2016 Jan 14;127(2):208-15
pubmed: 26486789
Blood. 2016 Jan 21;127(3):303-9
pubmed: 26492934
Lancet Oncol. 2016 Aug;17(8):1081-1093
pubmed: 27345636
Lancet. 2020 Apr 18;395(10232):1278-1291
pubmed: 32305093
Blood. 2019 Mar 7;133(10):1011-1019
pubmed: 30530801
J Immunol. 2012 Apr 1;188(7):3532-41
pubmed: 22368276
Blood. 2003 Feb 1;101(3):1071-9
pubmed: 12393727
Lancet Oncol. 2015 Oct;16(13):1370-9
pubmed: 26377300
Lancet Haematol. 2016 Jul;3(7):e317-29
pubmed: 27374465
J Immunol. 2014 Feb 15;192(4):1620-9
pubmed: 24431228
N Engl J Med. 2019 Aug 1;381(5):432-443
pubmed: 31365801
Blood. 2019 Jun 27;133(26):2765-2775
pubmed: 30862645
Blood. 2018 Jun 21;131(25):2745-2760
pubmed: 29540348
Lancet Haematol. 2018 Feb;5(2):e82-e94
pubmed: 29275118
J Clin Oncol. 2007 Mar 1;25(7):799-804
pubmed: 17283363
N Engl J Med. 2019 Jun 06;380(23):2225-2236
pubmed: 31166681
J Immunol. 2006 Nov 15;177(10):7435-43
pubmed: 17082663
J Immunol. 2008 Dec 1;181(11):8120-32
pubmed: 19018005
J Exp Med. 2004 Jun 21;199(12):1659-69
pubmed: 15210744
N Engl J Med. 2020 Jul 30;383(5):498-500
pubmed: 32726539
Blood. 2013 Dec 5;122(24):3951-9
pubmed: 24124086
N Engl J Med. 2014 Mar 20;370(12):1101-10
pubmed: 24401022
Nat Immunol. 2003 Sep;4(9):815
pubmed: 12942076
Haematologica. 2013 Aug;98(8):1259-63
pubmed: 23716541
Blood. 2015 Jan 29;125(5):762-6
pubmed: 25498911
Med Oncol. 2014 Aug;31(8):104
pubmed: 24985882
Blood. 2009 Apr 16;113(16):3765-72
pubmed: 19029438
Leukemia. 2017 Jul;31(7):1477-1481
pubmed: 28439111
J Immunol. 2004 Mar 1;172(5):3280-8
pubmed: 14978136

Auteurs

Sanjal Desai (S)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Medstar Washington Hospital Center, Washington, D.C., USA.
ORCID: 0000-0002-7892-2625

Clifton Mo (C)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Walter Reed National Military Medical Center, Bethesda, MD, USA.

Erika M Gaglione (EM)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
Department of Biochemistry and Molecular Genetics, University of Virginia School of Medicine, Charlottesville, VA, USA.

Constance M Yuan (CM)

Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, MD, USA.

Maryalice Stetler-Stevenson (M)

Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, MD, USA.

Xin Tian (X)

Office of Biostatistics Research, NHLBI, NIH, Bethesda, MD, USA.

Irina Maric (I)

Department of Laboratory Medicine, Clinical Research Center, NIH, Bethesda, MD, USA.

Laura Wake (L)

Department of Laboratory Medicine, Clinical Research Center, NIH, Bethesda, MD, USA.

Mohammed Z Farooqui (MZ)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.

Dennis C Drinkwater (DC)

Walter Reed National Military Medical Center, Bethesda, MD, USA.

Susan Soto (S)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.

Janet Valdez (J)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.

Thomas E Hughes (TE)

Department of Pharmacy, Clinical Research Center, NIH, Bethesda, MD, USA.

Pia Nierman (P)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.

Jennifer Lotter (J)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.

Gerald E Marti (GE)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.

Christopher Pleyer (C)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
ORCID: 0000-0002-9569-9605

Clare Sun (C)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
ORCID: 0000-0001-8498-4729

Jeanine Superata (J)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.

Cydney Nichols (C)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.

Sarah E M Herman (SEM)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.

Margaret A Lindorfer (MA)

Department of Biochemistry and Molecular Genetics, University of Virginia School of Medicine, Charlottesville, VA, USA.

Ronald P Taylor (RP)

Department of Biochemistry and Molecular Genetics, University of Virginia School of Medicine, Charlottesville, VA, USA.

Adrian Wiestner (A)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.

Inhye E Ahn (IE)

Hematology Branch, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD, USA.
ORCID: 0000-0003-3717-287X

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Classifications MeSH

questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Globulines › Sérum-globulines › Immunoglobulines › Anticorps › Anticorps monoclonaux › Anticorps monoclonaux humanisés › Risk-adapted, ofatumumab-based...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Association de médicaments › Protocoles de polychimiothérapie antinéoplasique › Risk-adapted, ofatumumab-based...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Risk-adapted, ofatumumab-based...
questionsmedicales.fr › Thérapeutique › Biothérapie › Immunothérapie › Risk-adapted, ofatumumab-based...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Caractéristiques de la maladie › Maladie chronique › Leucémie chronique lymphocytaire à cellules B › Risk-adapted, ofatumumab-based...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Risk-adapted, ofatumumab-based...