Faculty, Staff and Student Publications

Publication Date

9-1-2024

Journal

Leukemia & Lymphoma

DOI

10.1080/10428194.2024.2349700

PMID

38749022

PMCID

PMC11646483

PubMedCentral® Posted Date

9-1-2025

PubMedCentral® Full Text Version

Author MSS

Abstract

We report on the long-term efficacy and safety of a phase 2 trial of sequential cladribine and rituximab in hairy cell leukemia (HCL). One-hundred and thirty-nine patients were enrolled: 111 in the frontline setting, 18 in first relapse, and 10 with variant HCL (HCLv). A complete response (CR) was achieved in 133 of 137 evaluable participants (97%) with measurable residual disease (MRD) negativity in 102 (77%). MRD status was not associated with significant differences in event free survival (EFS) or overall survival (OS). With a median follow up of 7·8 years (range: 0·40–18·8), eight patients have experienced disease relapse (5·8%), 4/111 with newly diagnosed HCL (3·6%) and 4/10 with HCLv (40%) (p=0·002). The 10-year EFS and OS rates were 86·7% and 91·1%, respectively. Grade 3 adverse events were observed in 28 participants (20·1%), mostly due to infections. Treatment of HCL with sequential cladribine followed by rituximab is associated with excellent efficacy and safety results both in the frontline and relapsed settings.

Keywords

Humans, Leukemia, Hairy Cell, Cladribine, Rituximab, Male, Female, Antineoplastic Combined Chemotherapy Protocols, Middle Aged, Aged, Adult, Treatment Outcome, Aged, 80 and over, Follow-Up Studies, Neoplasm, Residual, HCL, HCLv, cladribine, rituximab, clinical trial

Published Open-Access

yes

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