High-Dose Vincristine Sulfate Liposome Injection, for Advanced, Relapsed, or Refractory Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in an Adolescent and Young Adult Subgroup of a Phase 2 Clinical Trial.

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  • Additional Information
    • Source:
      Publisher: Mary Ann Liebert, Inc Country of Publication: United States NLM ID: 101543508 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2156-535X (Electronic) Linking ISSN: 21565333 NLM ISO Abbreviation: J Adolesc Young Adult Oncol Subsets: MEDLINE
    • Publication Information:
      Original Publication: New Rochelle, NY : Mary Ann Liebert, Inc.
    • Subject Terms:
      Injections/*methods ; Liposomes/*therapeutic use ; Philadelphia Chromosome/*drug effects ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/*drug therapy ; Vincristine/*therapeutic use; Adolescent ; Adult ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Infant, Newborn ; Liposomes/pharmacology ; Male ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/pathology ; Recurrence ; Treatment Outcome ; Vincristine/pharmacology ; Young Adult
    • Abstract:
      Purpose: A study of vincristine sulfate (VCR) liposome injection (VSLI) was conducted in patients with advanced, relapsed, or refractory, Philadelphia chromosome-negative acute lymphoblastic/lymphocytic leukemia (ALL). A retrospective subgroup analysis of the results was performed to evaluate the safety and efficacy of VSLI in the adolescent and young adult (AYA) patients.
      Methods: Of the 65 patients treated in the pivotal Phase 2 Study HBS407 (NCT00495079), 44 patients were aged ≤39 years (median 27 [range 19-39] years) and were included in this analysis. Patients received VSLI (2.25 mg/m 2 intravenously every 7 ± 3 days) without dose capping or concurrent steroid administration in continuous 28-day cycles.
      Results: VSLI was well tolerated in the AYA patients over a median of 5 (range 1-15) doses administered. One-third of patients (36%) experienced treatment-related serious adverse events (AEs) with peripheral neuropathy (7%), tumor lysis syndrome (7%), and febrile neutropenia (5%) in >1 patient. Neuropathy-associated AEs occurred in 82% patients; no neuropathy-related deaths occurred. The rate of complete remission (CR) (with or without complete blood count recovery) by investigator assessment was 25% in AYA patients, and the overall response rate was 39%. Median leukemia-free survival in AYA patients attaining CR was 135 (range 32-463) days, and median overall survival was 141 (range 13-620) days.
      Conclusion: VSLI provided a meaningful clinical benefit to AYA patients with ALL, and its safety profile was comparable to that of VCR despite the delivery of higher doses (individual and cumulative).
    • Contributed Indexing:
      Keywords: acute lymphoblastic leukemia; vincristine sulfate liposome injection
    • Molecular Sequence:
      ClinicalTrials.gov NCT00495079
    • Accession Number:
      0 (Liposomes)
      5J49Q6B70F (Vincristine)
    • Publication Date:
      Date Created: 20180922 Date Completed: 20190917 Latest Revision: 20190917
    • Publication Date:
      20240105
    • Accession Number:
      10.1089/jayao.2018.0041
    • Accession Number:
      30239252