Long-term results of the sequential combination of cladribine and rituximab in Hairy cell leukemia.

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  • Additional Information
    • Source:
      Publisher: Taylor & Francis Country of Publication: United States NLM ID: 9007422 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1029-2403 (Electronic) Linking ISSN: 10268022 NLM ISO Abbreviation: Leuk Lymphoma Subsets: MEDLINE
    • Publication Information:
      Publication: [Philadelphia, PA] : Taylor & Francis
      Original Publication: Chur ; New York : London, UK : Harwood Academic Publishers ; Distributed by STBS, 1989-
    • Subject Terms:
      Leukemia, Hairy Cell*/drug therapy ; Leukemia, Hairy Cell*/mortality ; Leukemia, Hairy Cell*/pathology ; Cladribine*/administration & dosage ; Cladribine*/adverse effects ; Rituximab*/administration & dosage ; Rituximab*/adverse effects ; Antineoplastic Combined Chemotherapy Protocols*/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols*/adverse effects; Humans ; Male ; Female ; Middle Aged ; Aged ; Adult ; Treatment Outcome ; Aged, 80 and over ; Follow-Up Studies ; Neoplasm, Residual
    • 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.
    • Grant Information:
      P30 CA016672 United States CA NCI NIH HHS
    • Contributed Indexing:
      Keywords: HCL; HCLv; cladribine; clinical trial; rituximab
    • Accession Number:
      47M74X9YT5 (Cladribine)
      4F4X42SYQ6 (Rituximab)
    • Publication Date:
      Date Created: 20240515 Date Completed: 20240829 Latest Revision: 20240829
    • Publication Date:
      20240831
    • Accession Number:
      10.1080/10428194.2024.2349700
    • Accession Number:
      38749022