Blinatumomab after R-CHOP bridging therapy for patients with Richter transformation: a phase 2 multicentre trial.

Humans Male Female Antibodies, Bispecific / administration & dosage Antineoplastic Combined Chemotherapy Protocols / therapeutic use Middle Aged Cyclophosphamide / therapeutic use Rituximab / administration & dosage Doxorubicin / therapeutic use Aged Prednisone / therapeutic use Vincristine / therapeutic use Lymphoma, Large B-Cell, Diffuse / drug therapy Adult Aged, 80 and over Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy Treatment Outcome

Journal

Nature communications

ISSN: 2041-1723

Titre abrégé: Nat Commun

Pays: England

ID NLM: 101528555

Informations de publication

Date de publication:
09 Aug 2024

Historique:

received: 19 02 2024

accepted: 03 08 2024

medline: 10 8 2024

pubmed: 10 8 2024

entrez: 9 8 2024

Statut: epublish

Résumé

Richter transformation (RT) is an aggressive lymphoma occurring in patients with chronic lymphocytic leukaemia. Here we investigated the anti-CD3/anti-CD19 T-cell-engager blinatumomab after R-CHOP (i.e. rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with untreated RT of diffuse large B-cell lymphoma histology (NCT03931642). In this multicentre phase 2 study, patients without complete response (CR) after two cycles of R-CHOP were eligible to receive an 8-week blinatumomab induction via continuous vein infusion with stepwise dosing until 112 μg/day. The primary endpoint was the CR rate after blinatumomab induction and secondary endpoint included safety, response duration, progression-free and overall survival. Thirty-nine patients started the first cycle of R-CHOP, 25 of whom received blinatumomab. After blinatumomab induction, five (20%) patients achieved CR, four (16%) achieved partial response, and six (24%) were stable. Considering the entire strategy, the overall response rate in the full-analysis-set was 46% (n = 18), with CR in 14 (36%) patients. The most common treatment-emergent adverse events of all grades in the blinatumomab-safety-set included fever (36%), anaemia (24%), and lymphopaenia (24%). Cytokine release syndrome (grade 1/2) was observed in 16% and neurotoxicity in 20% of patients. Blinatumomab demonstrated encouraging anti-tumour activity (the trial met its primary endpoint) and acceptable toxicity in patients with RT.

Identifiants

DOI: 10.1038/s41467-024-51264-2 PMID: 39122717

pubmed: 39122717

doi: 10.1038/s41467-024-51264-2

pii: 10.1038/s41467-024-51264-2

doi:

Substances chimiques

Antibodies, Bispecific 0

Cyclophosphamide 8N3DW7272P

Rituximab 4F4X42SYQ6

Doxorubicin 80168379AG

Prednisone VB0R961HZT

Vincristine 5J49Q6B70F

blinatumomab 4FR53SIF3A

R-CHOP protocol 0

Types de publication

Journal Article Clinical Trial, Phase II Multicenter Study

Langues

eng

Sous-ensembles de citation

Pagination

6822

Informations de copyright

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